A Study of JNJ-64304500 in Participants With Alopecia Areata

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04740970
• Collaborator: (none)
• Enrollment: 0
• Locations: 22
• Arms: 2
• Anticipated Duration (Months): 15.9
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: JNJ-64304500; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 24, 2021
• Anticipated Primary Completion Date: Jun 2, 2022
• Anticipated Study Completion Date: Jul 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-64304500 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; JNJ-64304500 injection will be administered subcutaneously.
Placebo Comparator: Placebo Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.	Drug: Placebo; Matching placebo injection will be administered subcutaneously.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response [Week 24]

   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.

Secondary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Up to Weeks 24 and 38]

   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.

2. Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) [Up to Weeks 24 and 38]

   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.

3. Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention [Up to Weeks 24 and 38]

   Number of participants with AEs leading to discontinuation of study will be reported.

4. Number of Participants With Adverse Events Reasonably Related to Study Intervention [Up to Weeks 24 and 38]

   Number of participants with AEs reasonably related to study intervention will be reported.

5. Number of Participants With Adverse Events of Injection-Site Reactions [Up to Weeks 24 and 38]

   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.

6. Number of Participants with Adverse Events of Infections [Up to Weeks 24 and 38]

   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.

7. Number of Participants With Clinically Significant Abnormalities in Vital Signs [Up to Weeks 24 and 38]

   Number of participants with clinically significant abnormalities in vital signs including pulse rate, respiratory rate and blood pressure will be reported.

8. Number of Participants With Clinically Significant Abnormalities in Laboratory Tests [Up to Weeks 24 and 38]

   Number of participants with clinically significant abnormalities in laboratory tests including hematology and chemistry will be reported.

9. Percentage of Participants Achieving SALT50 Response [Week 24]

   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.

10. Percentage of Participants Achieving SALT75 Response [Week 24]

    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.

11. Change From Baseline in SALT Score at Week 24 [Baseline and 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).

12. Percent Change in SALT Score from Baseline at Week 24 [Baseline and 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).

13. Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10 [Week 24]

    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).

14. Percentage of Participants Achieving SALT Score <=20 [Week 24]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Columbia University Medical Center	New York	New York	United States	10032
6	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
7	University of Pittsburgh Department of Dermatology	Pittsburgh	Pennsylvania	United States	15213
8	Modern Research Associates	Dallas	Texas	United States	75231
9	Center for Clinical Studies	Webster	Texas	United States	77598
10	Sinclair Dermatology	East Melbourne		Australia	3002
11	Fremantle Dermatology	Fremantle		Australia	6160
12	St George Dermatology & Skin Cancer Centre	Kogarah		Australia	2217
13	Veracity Clinical Research	Woolloongabba		Australia	4102
14	CHU Bordeaux - Hopital St Andre	Bordeaux		France	33000
15	CHU de Nice Hopital de l Archet	Nice		France	06200
16	CHU Rouen - Hopital Charles Nicolle	Rouen		France	76031
17	Hamamatsu University Hospital	Hamamatsu		Japan	431-3192
18	Kyorin University Hospital	Mitaka		Japan	181-8611
19	Osaka City University Hospital	Osaka		Japan	545-8586
20	The Juntendo Tokyo Koto Geriatric Medical Center	Tokyo		Japan	136-0075
21	Tokyo Medical University Hospital	Tokyo		Japan	160-0023
22	Yamaguchi University Hospital	Ube		Japan	755-8505

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04740970
• Other Study ID Numbers: CR108941; 2020-004500-34; 64304500ALA2001
• First Posted: Feb 5, 2021
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

No Results Posted as of May 4, 2021