A Study of JNJ-64304500 in Participants With Alopecia Areata

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Brief Title

A Study of JNJ-64304500 in Participants With Alopecia Areata

Official 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

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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response

Secondary Outcome

 Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Condition

Alopecia Areata

Intervention

JNJ-64304500

Study Arms / Comparison Groups

 JNJ-64304500
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

March 24, 2021

Completion Date

July 20, 2022

Primary Completion Date

June 2, 2022

Eligibility Criteria

        Key Inclusion Criteria:

          -  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 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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Janssen Research & Development, LLC Clinical Trial, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04740970

Organization ID

CR108941

Secondary IDs

2020-004500-34

Responsible Party

Sponsor

Study Sponsor

Janssen Research & Development, LLC


Study Sponsor

Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC


Verification Date

April 2021