Status:
WITHDRAWN
A Study of JNJ-64304500 in Participants With Alopecia Areata
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04740970
Start Date
March 24 2021
End Date
July 20 2022
Last Update
May 4 2021
Active Locations (22)
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1
Forcare Clinical Research, Inc.
Tampa, Florida, United States, 33613
2
Indiana Clinical Trial Center
Plainfield, Indiana, United States, 46168
3
Dermatology Specialists
Louisville, Kentucky, United States, 40241
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029