Back to resultsA Study of JNJ-64304500 in Participants With Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-64304500
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
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
Sites / Locations
- Forcare Clinical Research, Inc.
- Indiana Clinical Trial Center
- Dermatology Specialists
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center
- Oregon Dermatology and Research Center
- University of Pittsburgh Department of Dermatology
- Modern Research Associates
- Center for Clinical Studies
- Sinclair Dermatology
- Fremantle Dermatology
- St George Dermatology & Skin Cancer Centre
- Veracity Clinical Research
- CHU Bordeaux - Hopital St Andre
- CHU de Nice Hopital de l Archet
- CHU Rouen - Hopital Charles Nicolle
- Hamamatsu University Hospital
- Kyorin University Hospital
- Osaka City University Hospital
- The Juntendo Tokyo Koto Geriatric Medical Center
- Tokyo Medical University Hospital
- Yamaguchi University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
JNJ-64304500
Placebo
Arm Description
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.
Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Number of Participants With Adverse Events Reasonably Related to Study Intervention
Number of participants with AEs reasonably related to study intervention will be reported.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
Full Information
NCT ID
NCT04740970
First Posted
February 3, 2021
Last Updated
April 29, 2021
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04740970
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor Decision.
Study Start Date
March 24, 2021 (Anticipated)
Primary Completion Date
June 2, 2022 (Anticipated)
Study Completion Date
July 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
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
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-64304500
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo SC injection at Week 0 and then every 2 weeks from Week 2 through Week 22.
Intervention Type
Drug
Intervention Name(s)
JNJ-64304500
Intervention Description
JNJ-64304500 injection will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo injection will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT)90 Response
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Adverse Events Leading to Discontinuation of Study Intervention
Description
Number of participants with AEs leading to discontinuation of study will be reported.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Adverse Events Reasonably Related to Study Intervention
Description
Number of participants with AEs reasonably related to study intervention will be reported.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Adverse Events of Injection-Site Reactions
Description
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.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants with Adverse Events of Infections
Description
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.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Description
Number of participants with clinically significant abnormalities in vital signs including pulse rate, respiratory rate and blood pressure will be reported.
Time Frame
Up to Weeks 24 and 38
Title
Number of Participants With Clinically Significant Abnormalities in Laboratory Tests
Description
Number of participants with clinically significant abnormalities in laboratory tests including hematology and chemistry will be reported.
Time Frame
Up to Weeks 24 and 38
Title
Percentage of Participants Achieving SALT50 Response
Description
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.
Time Frame
Week 24
Title
Percentage of Participants Achieving SALT75 Response
Description
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.
Time Frame
Week 24
Title
Change From Baseline in SALT Score at Week 24
Description
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).
Time Frame
Baseline and Week 24
Title
Percent Change in SALT Score from Baseline at Week 24
Description
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).
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving SALT Score Less Than or Equal to (<=) 10
Description
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).
Time Frame
Week 24
Title
Percentage of Participants Achieving SALT Score <=20
Description
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).
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Forcare Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Indiana Clinical Trial Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pittsburgh Department of Dermatology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Sinclair Dermatology
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
St George Dermatology & Skin Cancer Centre
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
CHU Bordeaux - Hopital St Andre
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Nice Hopital de l Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Rouen - Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
The Juntendo Tokyo Koto Geriatric Medical Center
City
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
ZIP/Postal Code
755-8505
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of JNJ-64304500 in Participants With Alopecia Areata
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