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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
Date last updated
4/05/2021

Titles & IDs
Public title
A Study of JNJ-64304500 in Participants With Alopecia Areata
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
Secondary ID [1] 0 0
2020-004500-34
Secondary ID [2] 0 0
CR108941
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Weeks 24 and 38
Secondary outcome [2] 0 0
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to Weeks 24 and 38
Secondary outcome [3] 0 0
Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention
Timepoint [3] 0 0
Up to Weeks 24 and 38
Secondary outcome [4] 0 0
Number of Participants With Adverse Events Reasonably Related to Study Intervention
Timepoint [4] 0 0
Up to Weeks 24 and 38
Secondary outcome [5] 0 0
Number of Participants With Adverse Events of Injection-Site Reactions
Timepoint [5] 0 0
Up to Weeks 24 and 38
Secondary outcome [6] 0 0
Number of Participants with Adverse Events of Infections
Timepoint [6] 0 0
Up to Weeks 24 and 38
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Timepoint [7] 0 0
Up to Weeks 24 and 38
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
Timepoint [8] 0 0
Up to Weeks 24 and 38
Secondary outcome [9] 0 0
Percentage of Participants Achieving SALT50 Response
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Percentage of Participants Achieving SALT75 Response
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Change From Baseline in SALT Score at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Percent Change in SALT Score from Baseline at Week 24
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10
Timepoint [13] 0 0
Week 24
Secondary outcome [14] 0 0
Percentage of Participants Achieving SALT Score <=20
Timepoint [14] 0 0
Week 24

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
24/03/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/07/2022
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [2] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [3] 0 0
St George Dermatology & Skin Cancer Centre - Kogarah
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
6160 - Fremantle
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Nice
Country [10] 0 0
France
State/province [10] 0 0
Rouen
Country [11] 0 0
Japan
State/province [11] 0 0
Hamamatsu
Country [12] 0 0
Japan
State/province [12] 0 0
Mitaka
Country [13] 0 0
Japan
State/province [13] 0 0
Osaka
Country [14] 0 0
Japan
State/province [14] 0 0
Tokyo
Country [15] 0 0
Japan
State/province [15] 0 0
Ube

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT04740970
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04740970