A Study of JNJ-64304500 in Participants With Alopecia Areata
NCT ID: NCT04740970
Last Updated: 2021-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-03-24
2022-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
JNJ-64304500
JNJ-64304500 injection will be administered subcutaneously.
Placebo
Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.
Placebo
Matching placebo injection will be administered subcutaneously.
Interventions
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JNJ-64304500
JNJ-64304500 injection will be administered subcutaneously.
Placebo
Matching placebo injection will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Forcare Clinical Research, Inc.
Tampa, Florida, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
Dermatology Specialists
Louisville, Kentucky, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
University of Pittsburgh Department of Dermatology
Pittsburgh, Pennsylvania, United States
Modern Research Associates
Dallas, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Sinclair Dermatology
East Melbourne, , Australia
Fremantle Dermatology
Fremantle, , Australia
St George Dermatology & Skin Cancer Centre
Kogarah, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
CHU Bordeaux - Hopital St Andre
Bordeaux, , France
CHU de Nice Hopital de l Archet
Nice, , France
CHU Rouen - Hopital Charles Nicolle
Rouen, , France
Hamamatsu University Hospital
Hamamatsu, , Japan
Kyorin University Hospital
Mitaka, , Japan
Osaka City University Hospital
Osaka, , Japan
The Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Yamaguchi University Hospital
Ube, , Japan
Countries
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Other Identifiers
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2020-004500-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64304500ALA2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108941
Identifier Type: -
Identifier Source: org_study_id
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