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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03952559
Registration number
NCT03952559
Ethics application status
Date submitted
15/05/2019
Date registered
16/05/2019
Date last updated
29/05/2024
Titles & IDs
Public title
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis
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Secondary ID [1]
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I4V-MC-JAIP
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Secondary ID [2]
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16966
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Universal Trial Number (UTN)
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Trial acronym
BREEZE-AD-PEDS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Topical corticosteroid
Experimental: Baricitinib Open Label High Dose (PK Lead-in) - Participants 10 to < 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD.
Participants 2 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.
Experimental: Baricitinib High Dose - Participants 10 to < 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD.
Participants 2 to < 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Experimental: Baricitinib Medium Dose - Participants 10 to < 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.
Participants 2 to < 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Experimental: Baricitinib Low Dose - Participants 10 to < 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD.
Participants 2 to < 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
Placebo Comparator: Placebo - Participants 10 to < 18 years received placebo tablets. Participants 2 to < 10 years received placebo as oral suspension.
Treatment: Drugs: Baricitinib
Administered orally
Treatment: Drugs: Placebo
Administered orally
Treatment: Drugs: Topical corticosteroid
Administered as standard-of-care
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a =2 Point Improvement
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Assessment method [1]
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Percentage of participants achieving IGA of 0 or 1 with a =2 point improvement is presented. The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
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Assessment method [2]
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Open label Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
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Timepoint [2]
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Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
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Primary outcome [3]
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Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
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Assessment method [3]
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Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
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Timepoint [3]
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Predose; 0.25 h; 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
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Secondary outcome [1]
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Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
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Assessment method [1]
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The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a = 75% improvement from baseline in the EASI score.
The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants Achieving EASI90
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Assessment method [2]
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The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a = 90% improvement from baseline in the EASI score.
The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI90.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Change From Baseline in EASI Score
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Assessment method [3]
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The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [3]
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Baseline, Week 16
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Secondary outcome [4]
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Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)
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Assessment method [4]
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The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a = 75% improvement from baseline in the SCORAD score.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) for Participants 10 to <18 Years Old at Study Entry
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Assessment method [5]
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The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Percentage of Participants Achieving EASI50
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Assessment method [6]
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The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a = 50% improvement from baseline in EASI score.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Percentage of Participants Achieving IGA of 0
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Assessment method [7]
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The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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Change From Baseline in SCORAD
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Assessment method [8]
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The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.
LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Percentage of Participants Achieving SCORAD90
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Assessment method [9]
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The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a = 90% improvement from baseline in the SCORAD score.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Change From Baseline in Body Surface Area (BSA) Affected
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Assessment method [10]
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Body surface area affected by atopic dermatitis will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of atopic dermatitis. LS Means calculated using MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [10]
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Baseline, Week 16
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Secondary outcome [11]
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Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment
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Assessment method [11]
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Percentage of participants developing skin infections requiring antibiotic treatment
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Mean Number of Days Without Use of Background Topical Corticosteroid (TCS)
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Assessment method [12]
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Mean number of days without use of background TCS was presented. The ANOVA model includes treatment, age cohort, region, and baseline disease severity (IGA) as factors.
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Timepoint [12]
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Baseline Through 16 Weeks
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Secondary outcome [13]
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Mean Gram Quantity of TCS Use (Tube Weights)
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Assessment method [13]
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The dispensed TCS tubes were weighed with cap (without the carton) to determine the dispensed amount of TCS in grams. Returned tubes were weighed with cap (without the carton) to determine the amount of TCS in grams used at each visit. Analysis was done via analysis of variance (ANOVA), with geographic region, baseline disease severity, and treatment as factors in the model.
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Timepoint [13]
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Baseline through 16 Weeks
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Secondary outcome [14]
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Change From Baseline in Itch NRS for Participants 10 to <18 Years at Study Entry
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Assessment method [14]
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The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [14]
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Baseline, Week 16
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Secondary outcome [15]
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Change From Baseline in the Parent-Reported Itch Severity Measure (PRISM) for Participants 2 to <10 Years at Study Entry
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Assessment method [15]
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The Parent-Reported Itch Severity Measure (PRISM) is a single-item, parent/caregiver administered scale that reports the overall severity of their child's itching. Parent/Caregiver's report the overall severity of their child's itching based on observed actions of the child in the past 24 hours. Response options range include "No Itch," "Mild," "Moderate," "Severe," and "Very Severe." The PRISM will be completed for participants <10 years old by the parent/caregiver.
LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [15]
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Baseline, Week 16
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Secondary outcome [16]
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Change From Baseline on the Patient-Oriented Eczema Measure (POEM) Total Score
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Assessment method [16]
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The POEM is a simple, 7-item, patient-administered scale that assesses disease severity in children and adults. Participants respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). Scores range from 0-28 with higher total scores indicating greater disease severity.
LS Means were calculated using MMRM model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [16]
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Baseline, Week 16
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Secondary outcome [17]
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Change From Baseline in Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score for Participants 10 to <18 Years at Study Entry
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Assessment method [17]
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The PGI-S-AD is a single-item question asked to the participants on how they would rate their overall atopic dermatitis symptoms over the past 24 hours to evaluate the severity of the disease at that point in time. The 5 categories of responses range from "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe".
LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [17]
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Baseline, Week 16
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Secondary outcome [18]
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Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Pediatric Depression for Participants 5 to <18 Years at Study Entry
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Assessment method [18]
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PROMIS is a set of person-centered measures that evaluates and monitors physical, mental and social health in adults and children. The PROMIS Depression item bank assesses self-reported negative mood (sadness, guilt), views on self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive affect and engagement (loss of interest, meaning, and purpose). The PROMIS Depression Short Form (8a v2.0 and 6a v2.0) is available in pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for children (ages 5 to <8 years). Children aged <5 years will not complete assessment. Both pediatric self-report and proxy-report versions assess depression "in past seven days." Response options range from 1 = Never;2 = Rarely;3 = Sometimes;4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean= 50 and a standard deviation = 10) with higher scores representing greater depression.
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Timepoint [18]
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Baseline, Week 16
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Secondary outcome [19]
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Change From Baseline in the PROMIS-Pediatric Anxiety for Participants 5 to <18 Years at Study Entry
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Assessment method [19]
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PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS Anxiety item bank assesses self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Anxiety Short Form (8 questions, 8a v2.0) is available in a pediatric self-report (ages 8 to <18 years) and for parents/caregivers serving as proxy reporters for their children (youth ages 5 to <8 years old). Children aged <5 years will not complete this assessment. Both pediatric self-report and proxy-report versions assess anxiety "in the past seven days." Response options range from 1= Never; 2 = Rarely; 3 = Sometimes; 4 = Often; to 5 = Almost always. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.
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Timepoint [19]
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Baseline, Week 16
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Secondary outcome [20]
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Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) at Week 16 for Participants 4 to <18 Years at Study Entry
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Assessment method [20]
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CDLQI is a validated 10 question tool to measure impact of skin disease on QOL in children by assessing how much the skin problem has affected the subjects over past week. Nine questions were scored as follows: Very much = 3, Quite a lot = 2, Only a little = 1, Not at all or unanswered = 0. Question 7 has an added possible response, which was scored as 3. CDLQI equals the sum of the score of each question (max. = 30, min. = 0). Higher the score, the greater the impact on QOL. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [20]
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Baseline, Week 16
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Secondary outcome [21]
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Change From Baseline in Infants' Dermatology Quality of Life Index (IDQOL) at Week 16 for Participants 2 to <4 Years at Study Entry
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Assessment method [21]
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Infants' Dermatitis Quality of Life Index (IDQOL) is used to evaluate quality of life for subjects of age less than 4 years. IDQOL questionnaires were designed for infants (below the age of 4 years) with atopic dermatitis. The IDQOL was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. A negative change from baseline indicated improvement. LS Means were calculated using mixed model repeated measures (MMRM) model includes treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [21]
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Week 16
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Secondary outcome [22]
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Change From Baseline on the Work Productivity and Activity Impairment: Atopic Dermatitis - Caregiver (WPAI-AD-CG) Score
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Assessment method [22]
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The Atopic Dermatitis Caregiver (WPAI-AD-CG) assesses the effect of a child's atopic dermatitis on the parent/caregiver's work productivity during the past 7 days. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, Scores are calculated as impairment percentages with higher scores indicating greater impairment and less productivity.
LS Mean were calculated using a MMRM model with treatment, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [22]
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0
Baseline, Week 16
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Secondary outcome [23]
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Change From Baseline on the European Quality of Life-5 Dimensions-Youth (EQ-5D-Y) for Participants 4 to <18 Years at Study Entry
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Assessment method [23]
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The EQ-5D-Y questionnaire is health status related and self-completed for pediatric participants =8 years old and completed by parents/caregivers for children 4 to <8 years old. Health state profile assessed health in 5 dimensions (Mobility,selfcare,usual activities,pain/discomfort, anxiety/depression) to obtain index score, each with three levels of response (no problems,some problems,a lot of problems). Participants indicated their health state by choosing appropriate level from each dimension. Visual analog scale on which participant rates their perceived health state from 0 ("worst health you can imagine") to 100 ("best health you can imagine") is presented.Higher the score the better the health status. LS Means uses MMRM model which includes treatment,age cohort,region,baseline disease severity(IGA),visit,treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [23]
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Baseline, Week 16
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Secondary outcome [24]
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Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) for Participants 10 to <18 Years at Study Entry
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Assessment method [24]
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Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually.
LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects.
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Timepoint [24]
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0
Baseline, Week 16
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Secondary outcome [25]
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Change From Baseline in Skin Pain NRS for Participants 10 to <18 Years at Study Entry
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Assessment method [25]
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Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.
LS Means were calculated using a MMRM model with treatment, age cohort, region, baseline disease severity (IGA), visit, treatment-by-age cohort interaction and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.
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Timepoint [25]
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0
Baseline, Week 16
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Secondary outcome [26]
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Number of Participant Responses With Suspension Acceptability and Palatability Assessment (PK Lead-In) for Participants <10 Years Old at Study Entry
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Assessment method [26]
0
0
The questionnaire for Suspension acceptability and palatability assessed the participants ability to swallow the oral suspension product, experience relating to the taste, smell and ease of administering and taking the suspension. The questionnaire contained following Questions: Question 1) How did you (your child) like the taste of the medicine? Question 2) How did you (your child) like the smell of the medicine? Question 3) How easy was it for you (your child) to take the medicine today? Question 4) How easy was it for you to use the oral syringe to give your child the dose today? Responses: Liked Very Much, Liked, Neither Liked nor Disliked, Disliked, Disliked Very Much, Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Query!
Timepoint [26]
0
0
Week 2
Query!
Secondary outcome [27]
0
0
Number of Participant Responses With Tablet Acceptability and Palatability Assessment (PK Lead-In) for Participants >=10 Years Old at Study Entry
Query!
Assessment method [27]
0
0
The questionnaire for tablet acceptability and palatability assessed the participants ability to swallow the tablet. The questionnaire contained the question 1) How easy was it for you (your child) to swallow the medicine today? Responses: Very Easy, Easy, Neither Easy nor Hard, Difficult (or Hard) and Very Difficult (or Hard). The number of participants with these responses are presented. Data is presented as "Question Number-Response-Time point".
Query!
Timepoint [27]
0
0
Week 2
Query!
Secondary outcome [28]
0
0
Height, Weight and Body Mass Index (BMI) Growth Rate
Query!
Assessment method [28]
0
0
Height, Weight and BMI Growth Rate will be reported.
Query!
Timepoint [28]
0
0
124 Weeks
Query!
Secondary outcome [29]
0
0
Change of Immunoglobulin G (IgG) Titers
Query!
Assessment method [29]
0
0
Number of participants with change of IgG titers for tetanus vaccine and pneumococcal conjugate will be presented. A primary immune response was assessed in participants who had never received tetanus or pneumococcal conjugate vaccines previously and secondary/booster responses were assessed if the participants had previously received the vaccines. For pneumococcal conjugate vaccine, number of participants with >= 2-fold increase in >=6 pneumococcal serotypes from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented. For tetanus vaccine, number of participants with >= 2-fold increase in participants with baseline titer >=0.1 IU/mL from pre-vaccination timepoint to specified post-vaccination timepoints through the end of the study will be presented.
Query!
Timepoint [29]
0
0
Baseline Through End of Study Completion
Query!
Secondary outcome [30]
0
0
Pop PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104
Query!
Assessment method [30]
0
0
Pop PK: Cmax,ss was derived by a population pharmacokinetics approach.
Query!
Timepoint [30]
0
0
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Query!
Secondary outcome [31]
0
0
Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104
Query!
Assessment method [31]
0
0
Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach.
Query!
Timepoint [31]
0
0
Predose; 0.25 hours (h); 0.5 h; 1 h; 2-4 h; 4 h and 4-6 h post dose
Query!
Eligibility
Key inclusion criteria
- At or above the 5th percentile of weight for age.
- Have been diagnosed with moderate to severe atopic dermatitis for at least 12 months
(if 6 years old or older) or at least 6 months (if 2 up to 6 years old).
- Have had inadequate response or intolerance to existing topical (applied to the skin)
medications within 6 months preceding screening.
- Are willing to discontinue certain treatments for eczema (such as systemic and topical
treatments during a washout period).
- Agree to use emollients daily.
Query!
Minimum age
2
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Are currently experiencing or have a history of other concomitant skin conditions
(e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory,
or unstable skin disease that requires frequent hospitalizations and/or intravenous
treatment for skin infections.
- A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode
of eczema herpeticum in the past.
- Participants who are currently experiencing a skin infection that requires treatment,
or is currently being treated, with topical or systemic antibiotics.
- Have any serious illness that is anticipated to require the use of systemic
corticosteroids or otherwise interfere with study participation or require active
frequent monitoring (e.g., unstable chronic asthma).
- Have been treated with the following therapies:
- Monoclonal antibody for less than 5 half-lives prior to beginning study
treatment.
- Received prior treatment with any oral Janus kinase (JAK) inhibitor.
- Received any parenteral corticosteroids administered by intramuscular or
intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks
prior to planned initiation of study drug or are anticipated to require
parenteral injection of corticosteroids during the study.
- Have had an intra-articular corticosteroid injection within 2 weeks prior to study
entry or within 6 weeks prior to planned initiation of study drug.
- Have high blood pressure characterized by a repeated systolic or diastolic blood
pressure >95th percentile based on age, sex and height.
- Have had major surgery within the past eight weeks or are planning major surgery
during the study.
- Have experienced any of the following within 12 weeks of screening: venous
thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart
disease, stroke, or New York Heart Association Stage III/IV heart failure.
- Have a history of VTE or are considered at high risk of VTE as deemed by the
investigator.
- Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver
disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative
disease or neuropsychiatric disorders or any other serious and/or unstable illness.
- Have a current or recent clinically serious viral, bacterial, fungal, or parasitic
infection including herpes zoster (shingles or chicken pox), tuberculosis.
- Have specific laboratory abnormalities.
- Have received certain treatments that are contraindicated.
- Pregnant or breastfeeding.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
Query!
Phase
Phase 3
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Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/05/2019
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/05/2026
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Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
516
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
The Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
0
0
Veracity Clinical Research Pty Ltd - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Royal Children's Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
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Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [3]
0
0
3052 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Ciudad Autonoma Buenos Aires
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Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Steiermark
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Vienna
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Wien
Query!
Country [6]
0
0
Brazil
Query!
State/province [6]
0
0
Rio Grande Do Sul
Query!
Country [7]
0
0
Brazil
Query!
State/province [7]
0
0
Sao Paulo
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Country [8]
0
0
Brazil
Query!
State/province [8]
0
0
Rio de Janeiro
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Country [9]
0
0
Brazil
Query!
State/province [9]
0
0
São Paulo
Query!
Country [10]
0
0
Czechia
Query!
State/province [10]
0
0
Hradec Králové
Query!
Country [11]
0
0
Czechia
Query!
State/province [11]
0
0
Nový Jicín
Query!
Country [12]
0
0
Czechia
Query!
State/province [12]
0
0
Praha 5
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Praha 8
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Praha 2
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Alpes-Maritimes
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Drôme
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Finistère
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Languedoc-Roussillon
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Loire-Atlantique
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Midi-Pyrénées
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Nord-Pas-de-Calais
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Hessen
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Nordrhein-Westfalen
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Sachsen
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Hamburg
Query!
Country [26]
0
0
Hungary
Query!
State/province [26]
0
0
Csongrad
Query!
Country [27]
0
0
Hungary
Query!
State/province [27]
0
0
Jasz-Nagykun-Szolnok
Query!
Country [28]
0
0
India
Query!
State/province [28]
0
0
Delhi
Query!
Country [29]
0
0
India
Query!
State/province [29]
0
0
Gujarat
Query!
Country [30]
0
0
Israel
Query!
State/province [30]
0
0
HaDarom
Query!
Country [31]
0
0
Israel
Query!
State/province [31]
0
0
HaMerkaz
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
HaTsafon
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Tell Abib
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Aichi
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Hiroshima
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Hokkaido
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Kanagawa
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Mie
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Osaka
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Tochigi
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Fukuoka
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Tokyo
Query!
Country [43]
0
0
Mexico
Query!
State/province [43]
0
0
Jalisco
Query!
Country [44]
0
0
Mexico
Query!
State/province [44]
0
0
Nuevo León
Query!
Country [45]
0
0
Mexico
Query!
State/province [45]
0
0
Durango
Query!
Country [46]
0
0
Mexico
Query!
State/province [46]
0
0
Veracruz
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Lodzkie
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Malopolskie
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Pomorskie
Query!
Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Krasnodarskiy Kray
Query!
Country [51]
0
0
Russian Federation
Query!
State/province [51]
0
0
Moskva
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
Tul'skaya Oblast'
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Barcelona [Barcelona]
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Madrid, Comunidad De
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Madrid
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Navarra
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Pontevedra [Pontevedra]
Query!
Country [58]
0
0
Taiwan
Query!
State/province [58]
0
0
Kaohsiung
Query!
Country [59]
0
0
Taiwan
Query!
State/province [59]
0
0
Taichung City
Query!
Country [60]
0
0
Taiwan
Query!
State/province [60]
0
0
Taipei
Query!
Country [61]
0
0
Taiwan
Query!
State/province [61]
0
0
Taoyuan
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Glasgow City
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
London, City Of
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
Nottinghamshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Eli Lilly and Company
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Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Incyte Corporation
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The reason for this study is to see if the study drug called baricitinib works and is safe in
children and teenage participants with atopic dermatitis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03952559
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03952559
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