Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04740970
Registration number
NCT04740970
Ethics application status
Date submitted
3/02/2021
Date registered
5/02/2021
Titles & IDs
Public title
A Study of JNJ-64304500 in Participants With Alopecia Areata
Query!
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
Query!
Secondary ID [1]
0
0
2020-004500-34
Query!
Secondary ID [2]
0
0
CR108941
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Autoimmune diseases
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [2]
0
0
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [3]
0
0
Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention
Query!
Assessment method [3]
0
0
Number of participants with AEs leading to discontinuation of study will be reported.
Query!
Timepoint [3]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [4]
0
0
Number of Participants With Adverse Events Reasonably Related to Study Intervention
Query!
Assessment method [4]
0
0
Number of participants with AEs reasonably related to study intervention will be reported.
Query!
Timepoint [4]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [5]
0
0
Number of Participants With Adverse Events of Injection-Site Reactions
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [6]
0
0
Number of Participants with Adverse Events of Infections
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [7]
0
0
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Query!
Assessment method [7]
0
0
Number of participants with clinically significant abnormalities in vital signs including pulse rate, respiratory rate and blood pressure will be reported.
Query!
Timepoint [7]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [8]
0
0
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
Query!
Assessment method [8]
0
0
Number of participants with clinically significant abnormalities in laboratory tests including hematology and chemistry will be reported.
Query!
Timepoint [8]
0
0
Up to Weeks 24 and 38
Query!
Secondary outcome [9]
0
0
Percentage of Participants Achieving SALT50 Response
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Week 24
Query!
Secondary outcome [10]
0
0
Percentage of Participants Achieving SALT75 Response
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Week 24
Query!
Secondary outcome [11]
0
0
Change From Baseline in SALT Score at Week 24
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Baseline and Week 24
Query!
Secondary outcome [12]
0
0
Percent Change in SALT Score from Baseline at Week 24
Query!
Assessment method [12]
0
0
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).
Query!
Timepoint [12]
0
0
Baseline and Week 24
Query!
Secondary outcome [13]
0
0
Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10
Query!
Assessment method [13]
0
0
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).
Query!
Timepoint [13]
0
0
Week 24
Query!
Secondary outcome [14]
0
0
Percentage of Participants Achieving SALT Score <=20
Query!
Assessment method [14]
0
0
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).
Query!
Timepoint [14]
0
0
Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Withdrawn
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
24/03/2021
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
20/07/2022
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
0
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment hospital [2]
0
0
Fremantle Dermatology - Fremantle
Query!
Recruitment hospital [3]
0
0
St George Dermatology & Skin Cancer Centre - Kogarah
Query!
Recruitment hospital [4]
0
0
Veracity Clinical Research - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [2]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Indiana
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kentucky
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Oregon
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Pennsylvania
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Bordeaux
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Nice
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Rouen
Query!
Country [11]
0
0
Japan
Query!
State/province [11]
0
0
Hamamatsu
Query!
Country [12]
0
0
Japan
Query!
State/province [12]
0
0
Mitaka
Query!
Country [13]
0
0
Japan
Query!
State/province [13]
0
0
Osaka
Query!
Country [14]
0
0
Japan
Query!
State/province [14]
0
0
Tokyo
Query!
Country [15]
0
0
Japan
Query!
State/province [15]
0
0
Ube
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04740970
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
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/NCT04740970