A Study of JNJ-64304500 in Participants With Alopecia Areata

Alopecia Areata Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04740970
• Other study ID #: CR108941
• Secondary ID: 2020-004500-3464
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 24, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: April 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 20, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• JNJ-64304500
JNJ-64304500 injection will be administered subcutaneously.
• Placebo
Matching placebo injection will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	Sinclair Dermatology	East Melbourne
Australia	Fremantle Dermatology	Fremantle
Australia	St George Dermatology & Skin Cancer Centre	Kogarah
Australia	Veracity Clinical Research	Woolloongabba
France	CHU Bordeaux - Hopital St Andre	Bordeaux
France	CHU de Nice Hopital de l Archet	Nice
France	CHU Rouen - Hopital Charles Nicolle	Rouen
Japan	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
United States	Modern Research Associates	Dallas	Texas
United States	Dermatology Specialists	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Pittsburgh Department of Dermatology	Pittsburgh	Pennsylvania
United States	Indiana Clinical Trial Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Forcare Clinical Research, Inc.	Tampa	Florida
United States	Center for Clinical Studies	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Number of participants with TEAEs will be reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Weeks 24 and 38
Secondary	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Number of participants with treatment-emergent SAEs will be reported. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Up to Weeks 24 and 38
Secondary	Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study will be reported.	Up to Weeks 24 and 38
Secondary	Number of Participants With Adverse Events Reasonably Related to Study Intervention	Number of participants with AEs reasonably related to study intervention will be reported.	Up to Weeks 24 and 38
Secondary	Number of Participants With Adverse Events of Injection-Site Reactions	Number of participants with AEs of injection-site reactions will be reported. An injection-site reaction is any AE at a subcutaneous (SC) study intervention injection-site.	Up to Weeks 24 and 38
Secondary	Number of Participants with Adverse Events of Infections	Number of participants with AEs of infections, including serious infections (including reactivation of latent infections) and infections requiring oral or parenteral antimicrobial treatment will be reported.	Up to Weeks 24 and 38
Secondary	Number of Participants With Clinically Significant Abnormalities in Vital Signs	Number of participants with clinically significant abnormalities in vital signs including pulse rate, respiratory rate and blood pressure will be reported.	Up to Weeks 24 and 38
Secondary	Number of Participants With Clinically Significant Abnormalities in Laboratory Tests	Number of participants with clinically significant abnormalities in laboratory tests including hematology and chemistry will be reported.	Up to Weeks 24 and 38
Secondary	Percentage of Participants Achieving SALT50 Response	Percentage of participants achieving SALT50 response will be reported. 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 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). SALT50 is defined as 50% or more regrowth from baseline.	Week 24
Secondary	Percentage of Participants Achieving SALT75 Response	Percentage of participants achieving SALT75 response will be reported. 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 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). SALT75 is defined as 75% or more regrowth from baseline.	Week 24
Secondary	Change From Baseline in SALT Score at Week 24	Change from baseline in SALT score at Week 24 will be reported. 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 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).	Baseline and Week 24
Secondary	Percent Change in SALT Score from Baseline at Week 24	Percent change from baseline in SALT score at Week 24 will be reported. 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 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).	Baseline and Week 24
Secondary	Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10	Percentage of participants with SALT score <=10 will be reported. 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 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).	Week 24
Secondary	Percentage of Participants Achieving SALT Score <=20	Percentage of participants with SALT score <=20 will be reported. 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 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).	Week 24