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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/NCT04740970
Registration number
NCT04740970
Ethics application status
Date submitted
3/02/2021
Date registered
5/02/2021
Date last updated
4/05/2021
Titles & IDs
Public title
A Study of JNJ-64304500 in Participants With Alopecia Areata
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Scientific title
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata
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Secondary ID [1]
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2020-004500-34
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Secondary ID [2]
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CR108941
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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:
Alopecia Areata
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Condition category
Condition code
Inflammatory and Immune System
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Autoimmune diseases
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-64304500
Treatment: Drugs - Placebo
Experimental: JNJ-64304500 - Participants will receive JNJ-64304500 dose 1 subcutaneous (SC) injection at Week 0 and then dose 2 SC injection every 2 weeks from Week 2 through Week 22.
Placebo Comparator: Placebo - Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.
Treatment: Drugs: JNJ-64304500
JNJ-64304500 injection will be administered subcutaneously.
Treatment: Drugs: Placebo
Matching placebo injection will be administered subcutaneously.
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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 a Severity of Alopecia Tool (SALT)90 Response
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Assessment method [1]
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The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of scalp surface area (SSA) in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent (%) of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss). SALT90 is defined as 90% or more regrowth compared with baseline.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [1]
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Number of participants with TEAEs will be reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Timepoint [1]
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Up to Weeks 24 and 38
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Secondary outcome [2]
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Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
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Assessment method [2]
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Number of participants with treatment-emergent SAEs will be reported. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [2]
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Up to Weeks 24 and 38
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Secondary outcome [3]
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Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention
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Assessment method [3]
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Number of participants with AEs leading to discontinuation of study will be reported.
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Timepoint [3]
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Up to Weeks 24 and 38
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Secondary outcome [4]
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Number of Participants With Adverse Events Reasonably Related to Study Intervention
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Assessment method [4]
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Number of participants with AEs reasonably related to study intervention will be reported.
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Timepoint [4]
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Up to Weeks 24 and 38
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Secondary outcome [5]
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Number of Participants With Adverse Events of Injection-Site Reactions
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Assessment method [5]
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Number of participants with AEs of injection-site reactions will be reported. An injection-site reaction is any AE at a subcutaneous (SC) study intervention injection-site.
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Timepoint [5]
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Up to Weeks 24 and 38
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Secondary outcome [6]
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Number of Participants with Adverse Events of Infections
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Assessment method [6]
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Number of participants with AEs of infections, including serious infections (including reactivation of latent infections) and infections requiring oral or parenteral antimicrobial treatment will be reported.
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Timepoint [6]
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Up to Weeks 24 and 38
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Secondary outcome [7]
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Number of Participants With Clinically Significant Abnormalities in Vital Signs
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Assessment method [7]
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Number of participants with clinically significant abnormalities in vital signs including pulse rate, respiratory rate and blood pressure will be reported.
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Timepoint [7]
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Up to Weeks 24 and 38
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Secondary outcome [8]
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Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
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Assessment method [8]
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Number of participants with clinically significant abnormalities in laboratory tests including hematology and chemistry will be reported.
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Timepoint [8]
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Up to Weeks 24 and 38
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Secondary outcome [9]
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Percentage of Participants Achieving SALT50 Response
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Assessment method [9]
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Percentage of participants achieving SALT50 response will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss). SALT50 is defined as 50% or more regrowth from baseline.
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Timepoint [9]
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Week 24
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Secondary outcome [10]
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Percentage of Participants Achieving SALT75 Response
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Assessment method [10]
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Percentage of participants achieving SALT75 response will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss). SALT75 is defined as 75% or more regrowth from baseline.
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Timepoint [10]
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Week 24
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Secondary outcome [11]
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Change From Baseline in SALT Score at Week 24
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Assessment method [11]
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Change from baseline in SALT score at Week 24 will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss).
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Timepoint [11]
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Baseline and Week 24
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Secondary outcome [12]
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Percent Change in SALT Score from Baseline at Week 24
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Assessment method [12]
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Percent change from baseline in SALT score at Week 24 will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss).
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Timepoint [12]
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Baseline and Week 24
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Secondary outcome [13]
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Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10
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Assessment method [13]
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Percentage of participants with SALT score <=10 will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss).
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Timepoint [13]
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Week 24
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Secondary outcome [14]
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Percentage of Participants Achieving SALT Score <=20
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Assessment method [14]
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Percentage of participants with SALT score <=20 will be reported. The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of SSA in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss).
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Timepoint [14]
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Week 24
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Eligibility
Key inclusion criteria
Key
- Participant has a physician confirmed diagnosis of moderate to severe Alopecia Areata
(AA) (greater than or equal to [>=] 50 percent [%] scalp involvement) as measured
using the severity of Alopecia tool (SALT) score; or participant has >=95% loss of
scalp hair for enrollment as alopecia totalis (AT) or alopecia universalis (AU)
subtypes at the time of screening and baseline
- Current episode of hair loss is greater than (>) 6 months (without evidence of
spontaneous terminal hair regrowth within 6 months at the time of screening and
baseline), but less than or equal to (<=8) years
- Medically stable on the basis of physical examination, medical history, vital signs,
and 12-lead electrocardiogram (ECG) performed at either screening or Week 0. Any
abnormalities, must be consistent with the underlying illness in the study population
and this determination must be recorded in the participant's source documents and
initialed by the investigator
- Medically stable on the basis of clinical laboratory tests performed at screening. If
the results of the serum chemistry panel or hematology are outside the normal
reference ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination must be
recorded in the participant's source documents and initialed by the investigator
Key
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Minimum age
18
Years
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Maximum age
65
Years
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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
- History of liver or renal insufficiency (estimated creatinine clearance below 60
milliliters per minute (mL/min)); significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine (except stable thyroid diseases), neurologic, hematologic,
rheumatologic, psychiatric disorders, or metabolic disturbances
- Currently has a malignancy or has a history of malignancy (with the exceptions of
participants having adequately treated and cured basal or squamous cell carcinoma of
the skin, or cervical carcinoma in situ occurring more than 5 years prior to
randomization)
- Known allergies, hypersensitivity, or intolerance to JNJ-64304500 or its excipients
- Participants with current episode of hair loss for >8 years
- Has previous treatment with an oral janus kinase (JAK) inhibitor
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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 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
Withdrawn
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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
24/03/2021
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Actual
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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
20/07/2022
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sinclair Dermatology - East Melbourne
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Recruitment hospital [2]
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Fremantle Dermatology - Fremantle
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Recruitment hospital [3]
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St George Dermatology & Skin Cancer Centre - Kogarah
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Recruitment hospital [4]
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Veracity Clinical Research - Woolloongabba
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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6160 - Fremantle
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Indiana
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Oregon
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Country [6]
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United States of America
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State/province [6]
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Pennsylvania
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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France
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State/province [8]
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Bordeaux
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Country [9]
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France
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State/province [9]
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Nice
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Country [10]
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France
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State/province [10]
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Rouen
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Country [11]
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Japan
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State/province [11]
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Hamamatsu
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Country [12]
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Japan
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State/province [12]
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Mitaka
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Country [13]
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Japan
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State/province [13]
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Osaka
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Country [14]
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Japan
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State/province [14]
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Tokyo
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Country [15]
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Japan
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State/province [15]
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Ube
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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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
The purpose of this study is to evaluate the clinical response of 22 weeks of study
intervention with JNJ-64304500, compared with placebo, in participants with moderate to
severe alopecia areata (AA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04740970
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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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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04740970
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