A Study of JNJ-64304500 in Participants With Alopecia Areata

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: JNJ-64304500
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |