A Study to Evaluate the Durability of Response of CTP-543... | NCT04784533 | Trialant
NCT04784533
Sponsor
Concert Pharmaceuticals
Status
Completed
Last Update Posted
Oct 9, 2024Actual
Enrollment
317Actual
Phase
Phase 2
Conditions
Alopecia Areata
Interventions
CTP-543
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04784533
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CP543.2004
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Official Title
A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Acronym
Not provided
Organization
Concert PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 26, 2021Actual
Primary Completion Date
May 16, 2023Actual
Completion Date
May 16, 2023Actual
First Submitted Date
Mar 3, 2021
First Submission Date that Met QC Criteria
Mar 3, 2021
First Posted Date
Mar 5, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 23, 2024
Results First Submitted that Met QC Criteria
Oct 3, 2024
Results First Posted Date
Oct 9, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 4, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 9, 2024Actual
Last Update Submitted Date
Oct 3, 2024
Last Update Posted Date
Oct 9, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Concert PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia Areata
Keywords
CTP-543
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
317Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Period 1 - CTP-543 8 mg BID
Experimental
Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.
Drug: CTP-543
Part A: Period 1 - CTP-543 12 mg BID
Experimental
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Drug: CTP-543
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Experimental
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Experimental
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Placebo Comparator
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CTP-543
Drug
Oral dosing
Part A: Period 1 - CTP-543 12 mg BID
Part A: Period 1 - CTP-543 8 mg BID
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
From Week 24 to Week 48
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
From Week 24 to Week 48
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
Week 24 of re-treatment
Secondary Outcomes
Measure
Description
Time Frame
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Weeks 28, 32, 36, 40, 44, and 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
At least 50% scalp hair loss, as defined by a severity of alopecia tool (SALT) score ≥50, at Screening and Baseline.
Willing to comply with the study visits and requirements of the study protocol.
Exclusion Criteria:
Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Total Skin and Beauty Dermatology Center, PC
Birmingham
Alabama
35205
United States
Center for Dermatology and Plastic Surgery/CCT Research
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
429 participants were screened, out of which 317 participants who experienced moderate to severe hair loss due to alopecia areata were enrolled to receive CTP-543 or placebo.
Recruitment Details
Participants were enrolled at study centers in the United States from 26 February 2021 to 16 May 2023.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
Drug: Placebo
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Experimental
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Experimental
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Experimental
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Experimental
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Drug: CTP-543
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Placebo
Drug
Oral dosing
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Weeks 28, 32, 36, 40, 44, and 48
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.
Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score). Negative change indicates no hair loss.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'.
Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Baseline, Weeks 12, 16, 20, and 24
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.
Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).
Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.
From first dose of study drug up to last follow up visit (Week 76)
Scottsdale
Arizona
85260
United States
Kern Research, Inc.
Bakersfield
California
93301
United States
Hope Clinical Research
Canoga Park
California
91303
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
University of California, Irvine
Irvine
California
92697
United States
Quest Dermatology Research
Northridge
California
91324
United States
Kaiser Permanente
Oakland
California
94611
United States
Palmtree Clinical Research, Inc.
Palm Springs
California
92262
United States
Kaiser Permanente
San Francisco
California
94118
United States
Colorado Center for Dermatology and Skin Surgery
Centennial
Colorado
80111
United States
Colorado Medical Research Center, Inc.
Denver
Colorado
80210
United States
Yale University Church Street Research Unit
New Haven
Connecticut
06519
United States
Skin Care Research, LLC
Boca Raton
Florida
33486
United States
Skin Care Research, LLC
Hollywood
Florida
33021
United States
DeNova Research
Chicago
Illinois
60611
United States
The Indiana Clinical Trials Center, PC
Plainfield
Indiana
46168
United States
DS Research
Louisville
Kentucky
40241
United States
Michigan Center for Research Company, LLC
Clarkston
Michigan
48346
United States
University of Minnesota Department of Dermatology
Minneapolis
Minnesota
55455
United States
Minnesota Clinical Study Center
New Brighton
Minnesota
55112
United States
Skin Specialists, PC
Omaha
Nebraska
68144
United States
Skin Laser and Surgery Specialists of New Jersey
Hackensack
New Jersey
07601
United States
Darst Dermatology
Charlotte
North Carolina
28277
United States
Dermatology Specialists of Charlotte
Charlotte
North Carolina
28277
United States
North Carolina Dermatology Associates, PLLC
Raleigh
North Carolina
27617
United States
Bexley Dermatology Research
Bexley
Ohio
43209
United States
Remington Davis
Columbus
Ohio
43215
United States
Vital Prospects Clinical Research Institute, PC
Tulsa
Oklahoma
74136
United States
Northwest Dermatology
Portland
Oregon
97210
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
Pennsylvania
19462
United States
PEAK Research, LLC
Upper Saint Clair
Pennsylvania
15241
United States
Rhode Island Hospital
Providence
Rhode Island
02903
United States
Clinical Research Center of the Carolinas
Charleston
South Carolina
29407
United States
Dermatology Treatment and Research Center, PA
Dallas
Texas
75230
United States
Austin Institute for Clinical Research
Houston
Texas
77056
United States
Austin Institute for Clinical Research, Inc.
Pflugerville
Texas
78660
United States
Springville Dermatology/CCT Research
Springville
Utah
84663
United States
West End Dermatology Associates
Richmond
Virginia
23233
United States
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
FG002
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
FG003
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
FG004
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
FG005
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
FG006
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
FG007
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
FG008
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
FG009
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
FG000180 subjects
FG001137 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Efficacy Population
Efficacy population included all participants who were randomized in the study, dispensed study drug, and had at least 1 post treatment severity of alopecia tool (SALT) assessment.
FG000178 subjects
FG001135 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG000162 subjects
FG001118 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG00018 subjects
FG00119 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Treatment Emergent or Worsening Adverse Event
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-compliance With Study Drug
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Reason not Specified
FG0005 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0005 subjects
FG0016 subjects
FG0020 subjects
FG0030 subjects
FG004
Part A: Period 2 (Week 24 to Week 48)
Type
Comment
Milestone Data
STARTED
The Part A Period 2 consists of participants from Part A Period 1 from each dose group who achieved an absolute SALT score of ≤20 at Week 24.
FG0000 subjects
FG0010 subjects
FG00218 subjects
FG00325 subjects
FG00418 subjects
FG00525 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00217 subjects
FG00325 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Part B (Day 1 to Week 24)
Type
Comment
Milestone Data
STARTED
The Part B consists of participants who achieved loss of regrowth maintenance (absolute SALT score of > 20) from Part A Period 2.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0078 subjects
FG00815 subjects
FG00919 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants included all participants who were randomized in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
BG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000180
BG001137
BG002317
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.0± 14.05
BG00139.6± 13.21
BG00239.8± 13.68
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000119
BG00193
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00013
BG00111
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG00014
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
From Week 24 to Week 48
ID
Title
Description
OG000
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
OG00018
OG00125
Title
Denominators
Categories
Title
Measurements
OG00027.8(7.1 to 48.5)
OG00132.0(13.7 to 50.3)
Primary
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
From Week 24 to Week 48
ID
Title
Description
OG000
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Primary
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Week 24 of re-treatment
ID
Title
Description
OG000
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
OG002
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Secondary
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 28, 32, 36, 40, 44, and 48
ID
Title
Description
OG000
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Secondary
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 28, 32, 36, 40, 44, and 48
ID
Title
Description
OG000
Part A: Period 2 - CTP-543 8 mg to Placebo
Participants who responded with an absolute SALT score of ≤20 at week 24 of the treatment period with 8 mg in Period 1, received CTP-543-matched placebo tablets, orally, for up to 24 weeks.
OG001
Part A, Period 2 - CTP-543 12 mg to CTP-543 Matched Placebo
Participants who responded with an absolute SALT score of ≤20 at week 24 of the treatment period with 12 mg in Period 1, received CTP-543 matched placebo tablets, orally, for up to 24 weeks
Units
Counts
Secondary
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
Secondary
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 8, 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
OG000
Secondary
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score). Negative change indicates no hair loss.
Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
Percent change
Baseline, Weeks 4, 8, 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Secondary
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of responders
Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
Secondary
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of responders
Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
Secondary
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Secondary
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
The Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Secondary
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 12, 16, 20, and 24
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Secondary
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.
Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment.
Posted
Number
95% Confidence Interval
Percentage of participants
Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
ID
Title
Description
OG000
Part B: CTP-543 8 mg to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
OG002
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Secondary
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).
Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
Percent change
Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
ID
Title
Description
OG000
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Secondary
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.
Safety population included all participants who received study drug during the treatment period.
Posted
Count of Participants
Participants
From first dose of study drug up to last follow up visit (Week 76)
ID
Title
Description
OG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
OG002
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Time Frame
From first dose of study drug up to last follow up visit (Week 76)
Description
All-cause mortality: All randomized participants included all participants who were randomized in the study.
Adverse events: Safety population included all participants who received study drug during the treatment period.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
0
180
1
180
91
180
EG001
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
0
137
5
137
82
137
EG002
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
0
18
0
18
9
18
EG003
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
0
25
0
25
10
25
EG004
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
0
18
2
18
7
18
EG005
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
0
25
0
25
9
25
EG006
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
0
5
0
5
2
5
EG007
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
0
8
0
8
5
8
EG008
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
0
15
0
15
12
15
EG009
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
0
19
0
19
14
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG0030 affected25 at risk
EG0040 affected18 at risk
EG0050 affected25 at risk
EG0060 affected5 at risk
EG0070 affected8 at risk
EG0080 affected15 at risk
EG0090 affected19 at risk
Thrombocytosis
Blood and lymphatic system disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Malignant Melanoma in Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Pancreatic Carcinoma Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Electrocardiogram T Wave Inversion
Investigations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Suicidal Ideation
Psychiatric disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asymptomatic COVID-19
Infections and infestations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0010 affected137 at risk
EG0021 affected18 at risk
EG0030 affected25 at risk
EG0040 affected18 at risk
EG0050 affected25 at risk
EG0060 affected5 at risk
EG0070 affected8 at risk
EG0080 affected15 at risk
EG0091 affected19 at risk
Candida infection
Infections and infestations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Conjunctivitis
Infections and infestations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
23.1
Systematic Assessment
EG00023 affected180 at risk
EG00121 affected137 at risk
EG0023 affected18 at risk
EG003
Folliculitis
Infections and infestations
23.1
Systematic Assessment
EG0004 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Fungal skin infection
Infections and infestations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
23.1
Systematic Assessment
EG00011 affected180 at risk
EG00110 affected137 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
23.1
Systematic Assessment
EG00011 affected180 at risk
EG0013 affected137 at risk
EG0020 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0014 affected137 at risk
EG0020 affected18 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0012 affected137 at risk
EG0021 affected18 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
23.1
Systematic Assessment
EG00023 affected180 at risk
EG00117 affected137 at risk
EG0020 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0014 affected137 at risk
EG0020 affected18 at risk
EG003
Dysaesthesia
Nervous system disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0021 affected18 at risk
EG003
Headache
Nervous system disorders
23.1
Systematic Assessment
EG00019 affected180 at risk
EG00120 affected137 at risk
EG0020 affected18 at risk
EG003
Memory impairment
Nervous system disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0021 affected18 at risk
EG003
Migraine
Nervous system disorders
23.1
Systematic Assessment
EG0003 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
23.1
Systematic Assessment
EG0003 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Contusion
Injury, poisoning and procedural complications
23.1
Systematic Assessment
EG0003 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0021 affected18 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
23.1
Systematic Assessment
EG0003 affected180 at risk
EG0012 affected137 at risk
EG0021 affected18 at risk
EG003
Amylase increased
Investigations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0021 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
C-reactive protein increased
Investigations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Haemoglobin decreased
Investigations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0013 affected137 at risk
EG0020 affected18 at risk
EG003
Lipase increased
Investigations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0011 affected137 at risk
EG0021 affected18 at risk
EG003
Neutrophil count decreased
Investigations
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Neutrophil percentage decreased
Investigations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Platelet count increased
Investigations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0011 affected137 at risk
EG0021 affected18 at risk
EG003
Red blood cell count decreased
Investigations
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Weight increased
Investigations
23.1
Systematic Assessment
EG0008 affected180 at risk
EG0018 affected137 at risk
EG0020 affected18 at risk
EG003
White blood cell count decreased
Investigations
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0019 affected137 at risk
EG0020 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
23.1
Systematic Assessment
EG0003 affected180 at risk
EG0013 affected137 at risk
EG0020 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0016 affected137 at risk
EG0020 affected18 at risk
EG003
Tonsillolith
Respiratory, thoracic and mediastinal disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Depression
Psychiatric disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Suicidal ideation
Psychiatric disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Eye disorder
Eye disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Visual impairment
Eye disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Crohn's disease
Gastrointestinal disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
23.1
Systematic Assessment
EG0004 affected180 at risk
EG0014 affected137 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
23.1
Systematic Assessment
EG0004 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Anaemia
Blood and lymphatic system disorders
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0012 affected137 at risk
EG0020 affected18 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
23.1
Systematic Assessment
EG0002 affected180 at risk
EG0014 affected137 at risk
EG0020 affected18 at risk
EG003
Bundle branch block left
Cardiac disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
23.1
Systematic Assessment
EG0000 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Blood creatine phosphokinase increased
Investigations
23.1
Systematic Assessment
EG0004 affected180 at risk
EG0011 affected137 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis
Infections and infestations
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
23.1
Systematic Assessment
EG0001 affected180 at risk
EG0010 affected137 at risk
EG0020 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG003
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
OG0005
OG0018
OG00215
OG00319
Title
Denominators
Categories
Title
Measurements
OG00060.0(17.1 to 100.0)
OG00150.0(15.4 to 84.6)
OG00266.7(54.0 to 99.8)
OG00373.7(58.6 to 97.0)
Participants
OG00018
OG00125
Title
Denominators
Categories
Week 28
Title
Measurements
OG0000(NA to NA)Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20
OG00112(2.5 to 31.2)
Week 32
Title
Measurements
OG0006.3(0.2 to 30.2)
OG0014.5(0.1 to 22.8)
Week 36
Title
Measurements
OG0000(NA to NA)Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20
OG0014.8(0.1 to 23.8)
Week 40
Title
Measurements
OG00012.5(1.6 to 38.3)
OG00110.5(1.3 to 33.1)
Week 44
Title
Measurements
OG0007.7(0.2 to 36.0)
OG0010(NA to NA)Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20
Week 48
Title
Measurements
OG0007.7(0.2 to 36.0)
OG0015.6(0.1 to 27.3)
Participants
OG00018
OG00125
Title
Denominators
Categories
Week 28
Title
Measurements
OG0000(NA to NA)Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20
OG00116.7(4.7 to 37.4)
Week 32
Title
Measurements
OG00016.7(3.6 to 41.4)
OG00114.3(3.0 to 36.3)
Week 36
Title
Measurements
OG00026.7(7.8 to 55.1)
OG00143.8(19.8 to 70.1)
Week 40
Title
Measurements
OG00036.4(10.9 to 69.2)
OG00122.2(2.8 to 60.0)
Week 44
Title
Measurements
OG00028.6(3.7 to 71.0)
OG0010(NA to NA)Not estimable as 0 participants achieved LOM criteria of SALT Score \> 20
Week 48
Title
Measurements
OG00040.0(5.3 to 85.3)
OG00128.6(3.7 to 71.0)
OG000178
OG001135
Title
Denominators
Categories
Week 12
Title
Measurements
OG00024.0(17.6 to 30.4)
OG00140.2(31.6 to 48.7)
Week 16
Title
Measurements
OG00026.9(20.2 to 33.7)
OG00139.1(30.6 to 47.5)
Week 20
Title
Measurements
OG00025.6(18.9 to 32.3)
OG00152.0(43.2 to 60.9)
Week 24
Title
Measurements
OG00028.8(21.9 to 35.8)
OG00148.7(39.8 to 57.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12
Difference in percentages
16.2
2-Sided
95
5.5
26.8
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 16
Difference in percentages
12.1
2-Sided
95
1.3
22.9
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 20
Difference in percentages
26.4
2-Sided
95
15.4
37.5
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 24
Difference in percentages
19.9
2-Sided
95
8.5
31.3
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
178
OG001135
Title
Denominators
Categories
Week 4
Title
Measurements
OG0000(NA to NA)Not estimable as 0 participants achieved SALT score criteria of ≤20
OG0010(NA to NA)Not estimable as 0 participants achieved SALT score criteria of ≤20
Week 8
Title
Measurements
OG0001.7(0.0 to 3.7)
OG0012.3(0.0 to 5.0)
Week 12
Title
Measurements
OG0005.8(2.3 to 9.3)
OG00116.4(10.0 to 22.8)
Week 16
Title
Measurements
OG00010.2(5.6 to 14.8)
OG00124.2(16.8 to 31.6)
Week 20
Title
Measurements
OG00015.9(10.3 to 21.4)
OG00135.2(26.8 to 43.7)
Week 24
Title
Measurements
OG00022.1(15.7 to 28.5)
OG00142.9(34.0 to 51.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 8
Difference in percentages
0.6
2-Sided
95
-2.7
3.9
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 12
Difference in percentages
10.6
2-Sided
95
3.3
17.9
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 16
Difference in percentages
14.0
2-Sided
95
5.3
22.8
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 20
Difference in percentages
19.4
2-Sided
95
9.2
29.5
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 24
Difference in percentages
20.8
2-Sided
95
9.8
31.7
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
Participants
OG000177
OG001132
Title
Denominators
Categories
Relative Change From Baseline at Week 4
ParticipantsOG000177
ParticipantsOG001132
Title
Measurements
OG000-0.5± 11.17
OG001-1.0± 8.73
Relative Change From Baseline at Week 8
ParticipantsOG000173
ParticipantsOG001128
Title
Measurements
OG000-7.4± 18.41
OG001
Relative Change From Baseline at Week 12
ParticipantsOG000172
ParticipantsOG001128
Title
Measurements
OG000-18.1± 27.42
OG001
Relative Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-26.3± 31.68
OG001
Relative Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001122
Title
Measurements
OG000-32.1± 34.26
OG001
Relative Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-38.2± 36.85
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 4
Least Square (LS) Mean Difference
-0.5
Standard Error of the Mean
1.18
2-Sided
95
-2.8
1.8
LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.
Superiority
OG000
OG001
Week 8
LS Mean Difference
-7.3
Standard Error of the Mean
2.32
2-Sided
95
-11.9
-2.7
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 12
LS Mean Difference
-12.4
Standard Error of the Mean
3.50
2-Sided
95
-19.3
-5.5
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 16
LS Mean Difference
-14.6
Standard Error of the Mean
3.90
2-Sided
95
-22.2
-6.9
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 20
LS Mean Difference
-15.4
Standard Error of the Mean
4.20
2-Sided
95
-23.7
-7.2
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 24
LS Mean Difference
-15.4
Standard Error of the Mean
4.36
2-Sided
95
-24.0
-6.8
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000178
OG001135
Title
Denominators
Categories
Week 12
Title
Measurements
OG00026.7(20.1 to 33.4)
OG00147.6(38.9 to 56.3)
Week 16
Title
Measurements
OG00037.7(30.4 to 45.1)
OG00151.6(42.9 to 60.2)
Week 20
Title
Measurements
OG00047.6(39.2 to 55.2)
OG00163.1(54.6 to 71.7)
Week 24
Title
Measurements
OG00050.3(42.6 to 58.0)
OG00164.7(56.1 to 73.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12
Difference in percentages
20.9
2-Sided
95
9.9
31.8
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 16
Difference in percentages
13.8
2-Sided
95
2.5
25.2
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 20
Difference in percentages
15.6
2-Sided
95
4.1
27.0
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 24
Difference in percentages
14.4
2-Sided
95
2.9
25.9
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000178
OG001135
Title
Denominators
Categories
Week 12
Title
Measurements
OG00029.8(23.0 to 36.7)
OG00152.8(44.1 to 61.4)
Week 16
Title
Measurements
OG00033.5(26.4 to 40.7)
OG00155.5(46.9 to 64.1)
Week 20
Title
Measurements
OG00040.9(33.3 to 48.4)
OG00163.4(54.9 to 71.9)
Week 24
Title
Measurements
OG00046.0(38.4 to 53.7)
OG00165.5(57.0 to 74.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12
Difference in percentages
22.9
2-Sided
95
11.9
34.0
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 16
Difference in percentages
21.9
2-Sided
95
10.7
33.1
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 20
Difference in percentages
22.6
2-Sided
95
11.2
33.9
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
OG000
OG001
Week 24
Difference in percentages
19.5
2-Sided
95
8.1
31.0
Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.
Superiority
Units
Counts
Participants
OG000172
OG001130
Title
Denominators
Categories
Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0006.4± 0.78
OG0016.3± 0.95
Change From Baseline at Week 12
ParticipantsOG000172
ParticipantsOG001127
Title
Measurements
OG000-0.8± 1.15
OG001
Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-1.1± 1.37
OG001
Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001122
Title
Measurements
OG000-1.3± 1.38
OG001
Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-1.6± 1.64
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12
LS Mean Difference
-0.6
Standard Error of the Mean
0.16
2-Sided
95
-0.9
-0.3
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 16
LS Mean Difference
-0.7
Standard Error of the Mean
0.18
2-Sided
95
-1.1
-0.4
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 20
LS Mean Difference
-0.8
Standard Error of the Mean
0.19
2-Sided
95
-1.2
-0.4
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 24
LS Mean Difference
-0.7
Standard Error of the Mean
0.20
2-Sided
95
-1.2
-0.3
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.
Superiority
Units
Counts
Participants
OG000172
OG001130
Title
Denominators
Categories
Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0006.4± 0.75
OG0016.4± 0.84
Change From Baseline at Week 12
ParticipantsOG000171
ParticipantsOG001127
Title
Measurements
OG000-0.8± 1.31
OG001
Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-1.0± 1.41
OG001
Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001123
Title
Measurements
OG000-1.1± 1.41
OG001
Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-1.4± 1.66
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Week 12
Least Square (LS) Mean Difference
-0.4
Standard Error of the Mean
0.16
2-Sided
95
-0.7
-0.1
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 16
LS Mean Difference
-0.7
Standard Error of the Mean
0.18
2-Sided
95
-1.0
-0.3
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 20
LS Mean Difference
-0.8
Standard Error of the Mean
0.18
2-Sided
95
-1.2
-0.5
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Week 24
LS Mean Difference
-0.8
Standard Error of the Mean
0.21
2-Sided
95
-1.2
-0.4
LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
Units
Counts
Participants
OG000172
OG001130
Title
Denominators
Categories
Satisfied Thickness Hair Coverage: Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0004.6± 0.74
OG0014.6± 0.67
Satisfied Thickness Hair Coverage: Change From Baseline at Week 12
ParticipantsOG000171
ParticipantsOG001127
Title
Measurements
OG000-0.9± 1.17
OG001
Satisfied Thickness Hair Coverage: Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-1.0± 1.15
OG001
Satisfied Thickness Hair Coverage: Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001123
Title
Measurements
OG000-1.1± 1.23
OG001
Satisfied Thickness Hair Coverage: Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-1.2± 1.38
OG001
Satisfied Evenness Hair Coverage: Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0004.7± 0.62
OG001
Satisfied Evenness Hair Coverage: Change From Baseline at Week 12
ParticipantsOG000171
ParticipantsOG001127
Title
Measurements
OG000-0.8± 1.09
OG001
Satisfied Evenness Hair Coverage: Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-0.9± 1.07
OG001
Satisfied Evenness Hair Coverage: Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001123
Title
Measurements
OG000-1.0± 1.11
OG001
Satisfied Evenness Hair Coverage: Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-1.1± 1.22
OG001
How Satisfied With Your Eyebrows: Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0004.0± 1.23
OG001
How Satisfied With Your Eyebrows: Change From Baseline at Week 12
ParticipantsOG000171
ParticipantsOG001127
Title
Measurements
OG000-0.8± 1.20
OG001
How Satisfied With Your Eyebrows: Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-1.0± 1.17
OG001
How Satisfied With Your Eyebrows: Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001123
Title
Measurements
OG000-1.0± 1.28
OG001
How Satisfied With Your Eyebrows: Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-1.1± 1.29
OG001
How Satisfied With Your Eyelashes: Baseline
ParticipantsOG000172
ParticipantsOG001130
Title
Measurements
OG0003.7± 1.40
OG001
How Satisfied With Your Eyelashes: Change From Baseline at Week 12
ParticipantsOG000171
ParticipantsOG001127
Title
Measurements
OG000-0.7± 1.12
OG001
How Satisfied With Your Eyelashes: Change From Baseline at Week 16
ParticipantsOG000167
ParticipantsOG001128
Title
Measurements
OG000-0.8± 1.25
OG001
How Satisfied With Your Eyelashes: Change From Baseline at Week 20
ParticipantsOG000164
ParticipantsOG001123
Title
Measurements
OG000-0.8± 1.22
OG001
How Satisfied With Your Eyelashes: Change From Baseline at Week 24
ParticipantsOG000163
ParticipantsOG001119
Title
Measurements
OG000-0.9± 1.28
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Satisfied Thickness Hair Coverage: Week 12
LS Mean Difference
-0.5
Standard Error of the Mean
0.13
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Thickness Hair Coverage: Week 16
LS Mean Difference
-0.4
Standard Error of the Mean
0.13
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Thickness Hair Coverage: Week 20
LS Mean Difference
-0.5
Standard Error of the Mean
0.13
2-Sided
95
-0.8
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Thickness Hair Coverage: Week 24
LS Mean Difference
-0.5
Standard Error of the Mean
0.14
2-Sided
95
-0.8
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Evenness Hair Coverage: Week 12
LS Mean Difference
-0.5
Standard Error of the Mean
0.12
2-Sided
95
-0.8
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Evenness Hair Coverage: Week 16
LS Mean Difference
-0.5
Standard Error of the Mean
0.12
2-Sided
95
-0.7
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Evenness Hair Coverage: Week 20
LS Mean Difference
-0.6
Standard Error of the Mean
0.13
2-Sided
95
-0.8
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
Satisfied Evenness Hair Coverage: Week 24
LS Mean Difference
-0.5
Standard Error of the Mean
0.14
2-Sided
95
-0.8
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyebrows: Week 12
LS Mean Difference
-0.5
Standard Error of the Mean
0.14
2-Sided
95
-0.8
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyebrows: Week 16
LS Mean Difference
-0.4
Standard Error of the Mean
0.13
2-Sided
95
-0.6
-0.1
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyebrows: Week 20
LS Mean Difference
-0.4
Standard Error of the Mean
0.14
2-Sided
95
-0.7
-0.1
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyebrows: Week 24
LS Mean Difference
-0.4
Standard Error of the Mean
0.14
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyelashes: Week 12
LS Mean Difference
-0.5
Standard Error of the Mean
0.13
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyelashes: Week 16
LS Mean Difference
-0.5
Standard Error of the Mean
0.13
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyelashes: Week 20
LS Mean Difference
-0.5
Standard Error of the Mean
0.13
2-Sided
95
-0.7
-0.2
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
OG000
OG001
How Satisfied With Your Eyelashes: Week 24
LS Mean Difference
-0.5
Standard Error of the Mean
0.14
2-Sided
95
-0.8
-0.3
LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.
Superiority
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG003
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
OG0005
OG0018
OG00215
OG00319
Title
Denominators
Categories
Week 4
Title
Measurements
OG00060.0(17.1 to 100.0)
OG00162.5(29.0 to 96.0)
OG00226.7(4.3 to 49.0)
OG00315.8(0.0 to 32.2)
Week 8
Title
Measurements
OG000100.0(100.0 to 100.0)
OG00162.5(29.0 to 96.0)
OG00223.1(0.2 to 46.0)
OG003
Week 12
Title
Measurements
OG00080.0(44.9 to 100.0)
OG00162.5(29.0 to 96.0)
OG00230.8(5.7 to 55.9)
OG003
Week 16
Title
Measurements
OG00060.0(17.1 to 100.0)
OG00162.5(29.0 to 96.0)
OG00250.0(21.7 to 78.3)
OG003
Week 20
Title
Measurements
OG00060.0(17.1 to 100.0)
OG00162.5(29.0 to 96.0)
OG00269.2(44.1 to 94.3)
OG003
Week 24
Title
Measurements
OG00060.0(17.1 to 100.0)
OG00150.0(15.4 to 84.6)
OG00276.9(54.0 to 99.8)
OG003
OG002
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG003
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
Units
Counts
Participants
OG0005
OG0018
OG00215
OG00319
Title
Denominators
Categories
Relative Change From Baseline at Week 4
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00215
ParticipantsOG00319
Title
Measurements
OG000-20.8± 15.27
OG001-1.5± 69.43
OG00212.1± 39.44
OG003
Relative Change From Baseline at Week 8
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG00318
Relative Change From Baseline at Week 12
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG00316
Relative Change From Baseline at Week 16
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00318
Relative Change From Baseline at Week 20
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG00317
Relative Change From Baseline at Week 24
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG00213
ParticipantsOG00318
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
OG003
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG004
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
OG005
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
OG006
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG007
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
OG008
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
OG009
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.