A Study of JNJ-64304500 in Participants With Alopecia Areata

NCT04740970 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: CR1089412020-004500-3464304500ALA2001
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 22

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).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

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

  The SALT score is a global severity score that captures percentage of hair loss by dividing the scalp into 4 quadrants (left side, right side, top and back quadrant) with assigned percent of scalp surface area (SSA) in each quadrant. After indicating the percent of loss per quadrant the value is multiplied by the percent (%) of hair for each section (18% sides, 40% top, and 24% back) and the values are summed to generate the total percentage of scalp hair loss or SALT score. The range in score is from 0-100 reflecting the percent hair loss on the scalp (0=no hair loss and 100= total hair loss). SALT90 is defined as 90% or more regrowth compared with baseline.

  Week 24

Secondary Outcomes (14)

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

  Up to Weeks 24 and 38

• Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

  Up to Weeks 24 and 38

• Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention

  Up to Weeks 24 and 38

• Number of Participants With Adverse Events Reasonably Related to Study Intervention

  Up to Weeks 24 and 38

• Number of Participants With Adverse Events of Injection-Site Reactions

  Up to Weeks 24 and 38

Study Arms (2)

JNJ-64304500

EXPERIMENTAL

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.

Drug: JNJ-64304500

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.

Drug: Placebo

Interventions

JNJ-64304500 DRUG

JNJ-64304500 injection will be administered subcutaneously.

JNJ-64304500

Placebo DRUG

Matching placebo injection will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (22)

Forcare Clinical Research, Inc.

Tampa, Florida, 33613, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40241, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Sinclair Dermatology

East Melbourne, 3002, Australia

Location

Fremantle Dermatology

Fremantle, 6160, Australia

Location

St George Dermatology & Skin Cancer Centre

Kogarah, 2217, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

CHU Bordeaux - Hopital St Andre

Bordeaux, 33000, France

Location

CHU de Nice Hopital de l Archet

Nice, 06200, France

Location

CHU Rouen - Hopital Charles Nicolle

Rouen, 76031, France

Location

Hamamatsu University Hospital

Hamamatsu, 431-3192, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

The Juntendo Tokyo Koto Geriatric Medical Center

Tokyo, 136-0075, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Yamaguchi University Hospital

Ube, 755-8505, Japan

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: March 24, 2021
• Primary Completion: June 2, 2022
• Study Completion: July 20, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (6); FR (3); AU (4); US (9)