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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05158023
Registration number
NCT05158023
Ethics application status
Date submitted
2/12/2021
Date registered
15/12/2021
Titles & IDs
Public title
Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis
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Secondary ID [1]
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ASLAN004-003
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Universal Trial Number (UTN)
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Trial acronym
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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 - Placebo Comparator
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004
Treatment: Other - ASLAN004
Placebo comparator: Placebo every two weeks q2w - Placebo q2w - placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every 2 weeks (q2w) from Week 2 to Week 14.
Experimental: ASLAN004 300 mg q2w - ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.
Experimental: ASLAN004 400 mg q2w - ASLAN004 400 mg q2w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14.
Experimental: ASLAN004 400 mg every four weeks q4w - ASLAN004 400 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg or alternating placebo (q2W) to Week 14.
Experimental: ASLAN004 600 mg q4w - ASLAN004 600 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 600 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14.
Treatment: Drugs: Placebo Comparator
Sterile solution for subcutaneous injection
Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection
Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection
Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection
Treatment: Other: ASLAN004
Sterile solution for subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
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Assessment method [1]
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The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
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Timepoint [1]
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Baseline, Week 16
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Secondary outcome [1]
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Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16
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Assessment method [1]
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IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Proportion of patients with EASI 50, 75 and 90 at Week 16
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Assessment method [2]
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EASI scores range from 0 to 72 (severe)The EASI responder is defined as a participant who achieves a =50% improvement (EASI 50), =75% improvement (EASI 75), or =90% improvement (EASI 90) from baseline in the EASI score.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Proportion of patients with EASI <7 at Week 16
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Assessment method [3]
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EASI scores range from 0 to 72 (severe)
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Percent Change in EASI score from Baseline over time
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Assessment method [4]
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EASI scores range from 0 to 72 (severe)
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [5]
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Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time
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Assessment method [5]
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The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [6]
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Proportion of patients achieving a 4-point reduction in P-NRS
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Assessment method [6]
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The P-NRS is an 11-point scale used by patients to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating the worst itch imaginable. Pruritus assessments will be recorded daily by the patient using an electronic diary.
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Timepoint [6]
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Baseline, Week 16
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Secondary outcome [7]
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Change in Body Surface Area (BSA) affected with AD
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Assessment method [7]
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BSA ranges from 0% to 100 % with higher values representing greater extent of AD.
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Timepoint [7]
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Baseline, Week 16
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Secondary outcome [8]
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Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16
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Assessment method [8]
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The SCORAD is a validated measure of the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16
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Assessment method [9]
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The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the patient's perception of the impact of AD disease symptoms and treatment on their quality of life (QoL). The 10 questions assess QoL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease). A high score is indicative of a poor QoL.
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Timepoint [9]
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Baseline, Week 16
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Secondary outcome [10]
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Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16
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Assessment method [10]
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The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life \[QOL\])
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Timepoint [10]
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Baseline to Week 16
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Secondary outcome [11]
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Change in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm from Baseline to Week 16
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Assessment method [11]
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The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine
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Timepoint [11]
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Baseline, Week 16
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Secondary outcome [12]
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Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16
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Assessment method [12]
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HADS is a 14-item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The total HADS score or subscores may be regarded as a global measure of psychological distress; higher scores indicate greater levels of anxiety or depression.
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Timepoint [12]
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Baseline to Week 16
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Secondary outcome [13]
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Absolute and percent change in sleep disturbance SD-NRS over time
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Assessment method [13]
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The SD-NRS is an 11-point scale used by patients to assess their sleep disturbance severity over the past 24 hours, with 0 indicating no or minimal sleep disturbance and 10 indicating the worst imaginable sleep disturbance. SD-NRS assessments will be recorded daily by the patient using an electronic diary.
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Timepoint [13]
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Baseline to Week 16
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Secondary outcome [14]
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Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16
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Assessment method [14]
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Timepoint [14]
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Baseline to Week 16
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Secondary outcome [15]
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Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28
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Assessment method [15]
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TEAEs are defined as AEs that develop or worsen or become serious during on-treatment period (time from the first dose of study drug until Week 28. A TESAE is defined as any untoward medical occurrence that results in any of the following outcomes: death, life-threatening, requires initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or is considered as medically important event. Any TEAE includes participants with both serious and non-serious AEs.
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Timepoint [15]
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: Baseline to Week 28
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Eligibility
Key inclusion criteria
1. Male or female patients with a clinical diagnosis of AD for at least 1 year;
2. vIGA score of =3 at Screening and Baseline;
3. =10% BSA of AD involvement at Screening and Baseline;
4. EASI score =16 at Screening and Baseline;
5. History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
6. Twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
2. Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
3. Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
4. Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;
1. Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
2. Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004;
3. Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
4. Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit;
5. Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
6. History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
7. History of immunosuppression including history of invasive opportunistic infections;
8. Treatment with live attenuated vaccine within 8 weeks prior to randomization;
9. Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
10. Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
11. Pregnant or breastfeeding women;
12. Patients unwilling to use adequate birth control.
13. Active COVID infection at baseline.
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Study design
Purpose of the study
Treatment
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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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/09/2023
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Sample size
Target
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Premier Specialist - Kogarah
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Recruitment hospital [2]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [3]
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Veracity Clinical Research - Woolloongabba
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Recruitment hospital [4]
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Eastern Clinical Research - Box Hill
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Recruitment hospital [5]
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Skin Health Institute - Carlton
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Recruitment hospital [6]
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Fremantle Dermatology - Fremantle
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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6160 - Fremantle
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Indiana
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Visakhapatnam
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Hamilton
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Poland
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Bydgoszcz
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Katowice
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Lódz
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Singapore
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
ASLAN Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).
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Trial website
https://clinicaltrials.gov/study/NCT05158023
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Chief Medical Officer
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Address
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ASLAN Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05158023