Clinical trial NCT04740970: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Adverse Events Reasonably Related to Study Intervention
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Adverse Events of Injection-Site Reactions
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants with Adverse Events of Infections
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Weeks 24 and 38
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
timeFrame: Up to Weeks 24 and 38
measure: Percentage of Participants Achieving SALT50 Response
timeFrame: Week 24
measure: Percentage of Participants Achieving SALT75 Response
timeFrame: Week 24
measure: Change From Baseline in SALT Score at Week 24
timeFrame: Baseline and Week 24
measure: Percent Change in SALT Score from Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10
timeFrame: Week 24
measure: Percentage of Participants Achieving SALT Score <=20
timeFrame: Week 24
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Forcare Clinical Research, Inc.
state: Florida
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Dermatology
state: Pennsylvania
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
city: Fremantle
country: Australia
facility: Fremantle Dermatology
city: Kogarah
country: Australia
facility: St George Dermatology & Skin Cancer Centre
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Bordeaux
country: France
facility: CHU Bordeaux - Hopital St Andre
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet
city: Rouen
country: France
facility: CHU Rouen - Hopital Charles Nicolle
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Mitaka
country: Japan
facility: Kyorin University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Tokyo
country: Japan
facility: The Juntendo Tokyo Koto Geriatric Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Ube
country: Japan
facility: Yamaguchi University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: