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Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (THRIVE-AA2)

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CTP-543 matching placebo
CTP-543
Sponsored by
Concert Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia, Hair loss, Hair disease, CTP-543

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical presentation compatible with alopecia areata with a current episode 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 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.

Sites / Locations

  • Alliance Dermatology & Mohs Center
  • Johnson Dermatology
  • Dermatology Research Associates
  • University of Miami Hospital
  • Floridian Research Institute LLC
  • MetroBoston Clinical Partners, LLC
  • Clinical Research Institute of Michigan, LLC
  • Hamzavi Dermatology
  • Galen Research
  • Vivida Dermatology
  • The Dermatology Group P.C.
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center - Department of Dermatology
  • University of Rochester
  • Dermatologists of Southwest Ohio
  • Oregon Medical Research
  • Velocity Clinical Research - Providence
  • The Skin Wellness Center
  • North Texas Center for Clinical Research
  • Elixir Research Group
  • Progressive Clinical Research
  • Velocity Clinical Research/Gateway
  • Velocity Clinical Research/Swinyer-Woseth Dermatology
  • Jordan Valley Dermatology Center
  • The Rector and Visitors of the University of Virginia
  • Care Clinic Ltd.
  • Medical Arts Health Research Group
  • Kingsway Clinical Research
  • North Bay Dermatology Centre
  • The Centre for Dermatology
  • Centre de Recherche Saint-Louis
  • Centre de Recherche Dermatologique du Quebec Metropolitan
  • Centre Hospitalier Universitaire de Nice - Hôpital Archet 2
  • Chru de Brest - Hôpital Morvan
  • Universitaetsklinikum Tübingen
  • Klinikum Rechts Der Isar, Technische Universität München
  • Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie
  • Fachklinik Bad Bentheim - Dermatologische Studienambulanz
  • Dermatologische Studienambulanz
  • University Hospital Muenster
  • Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
  • Universitätsklinikum Erlangen Hautklinik
  • Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika
  • Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika
  • Bugát Pál Kórház
  • Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika
  • Wromedica I. Bielicka, A. Strzalkowska S.C.
  • Twoja Przychodnia - Centrum Medyczne Nowa Sól
  • Etg Siedlce
  • Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.
  • Rcmed Oddzial Warszawa
  • Carpe Diem Centrum Medycyny Estetycznej
  • Etg Warszawa
  • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Etg Skierniewice
  • Hospital Del Mar
  • Hospital Santa Creu I Sant Pau
  • Hospital Clinic de Barcelona
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas
  • Hospital Doce de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Infanta Leonor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

CTP-543 8 mg BID

CTP-543 12 mg BID

Arm Description

Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.

Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 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).

Secondary Outcome Measures

Percentage of Responders on the Hair Satisfaction Participants 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. Responders were defined as participants with responses of "satisfied" or "very satisfied".
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
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 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).
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).
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).
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.
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.
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.
Change in the SPRO Scale From Baseline 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. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
SPRO is a questionnaire answered by the participants 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.
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 indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
HADS is questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Percentage of Participants Achieving an Absolute SALT Score of ≤10 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).

Full Information

First Posted
March 10, 2021
Last Updated
June 30, 2023
Sponsor
Concert Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04797650
Brief Title
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Acronym
THRIVE-AA2
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia, Hair loss, Hair disease, CTP-543

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
517 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
Arm Title
CTP-543 8 mg BID
Arm Type
Experimental
Arm Description
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Arm Title
CTP-543 12 mg BID
Arm Type
Experimental
Arm Description
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
CTP-543 matching placebo
Intervention Description
Administered as tablets.
Intervention Type
Drug
Intervention Name(s)
CTP-543
Intervention Description
Administered as tablets.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
Description
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).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Description
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. Responders were defined as participants with responses of "satisfied" or "very satisfied".
Time Frame
Weeks 12, 16, 20, and 24
Title
Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20
Description
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).
Time Frame
Weeks 4, 8, 12, 16, and 20
Title
Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Description
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).
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24
Description
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).
Time Frame
Weeks 12, 16, 20, and 24
Title
Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Description
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).
Time Frame
Weeks 12, 16, 20, and 24
Title
Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Weeks 12, 16, 20, and 24
Title
Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Weeks 12, 16, 20, and 24
Title
Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24
Description
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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported.
Time Frame
Baseline, Weeks 12, and 24
Title
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Description
BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows.
Time Frame
Baseline, Weeks 12, and 24
Title
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
Description
BELA is a clinician-rated scale that assesses the total eyelash hair present. The BELA is calculated based on distribution and grade values, ranging from 0 (no eyelashes) to 3 (full eyelashes). The BELA score is the sum of the individual scores for the left and right eyes, ranging from 0 to 6. Higher scores indicate less hair loss of eyelashes. A positive change from baseline indicates less hair loss of eyelashes.
Time Frame
Baseline, Weeks 12, and 24
Title
Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24
Description
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. Higher scores indicate the greater hair dissatisfaction. A negative change from baseline indicate the greater hair satisfaction.
Time Frame
Baseline, Weeks 12, 16, 20 and 24
Title
Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24
Description
SPRO is a questionnaire answered by the participants 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.
Time Frame
Weeks 12, 16, 20, and 24
Title
Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Description
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 indicate the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Time Frame
Baseline, Weeks 12, 16, 20, and 24
Title
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Description
HADS is questionnaire designed to assess anxiety and depression symptoms which is completed by participants. The questionnaire is comprised of two separate scales with a total of 14 items: A 7-item scale related to anxiety and 7-item scale related to depression. Each item within both scales is scored using a 4-point scale, ranging from 0 to 3 and the total scores in each scale can range from 0 to 21. Separate scores were created for anxiety and depression. A score between 0-7 is considered normal, 8-10 is mild, 11-14 is moderate, and >14 is severe anxiety or depression. Higher scores indicate greater severity. A negative change from baseline indicates less severity.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24
Description
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical presentation compatible with alopecia areata with a current episode 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.
Facility Information:
Facility Name
Alliance Dermatology & Mohs Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Facility Name
Floridian Research Institute LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
MetroBoston Clinical Partners, LLC
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48087
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Galen Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Vivida Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
The Dermatology Group P.C.
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center - Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Oregon Medical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Velocity Clinical Research - Providence
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
North Texas Center for Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Elixir Research Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Velocity Clinical Research/Gateway
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84101
Country
United States
Facility Name
Velocity Clinical Research/Swinyer-Woseth Dermatology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Jordan Valley Dermatology Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
The Rector and Visitors of the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Care Clinic Ltd.
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N6V7
Country
Canada
Facility Name
Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X1Y9
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B1A5
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitan
City
Quebec
ZIP/Postal Code
L4B1A5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital Archet 2
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06202 CEDEX 3
Country
France
Facility Name
Chru de Brest - Hôpital Morvan
City
Brest
State/Province
Finestère
ZIP/Postal Code
29609 CEDEX
Country
France
Facility Name
Universitaetsklinikum Tübingen
City
Tübingen
State/Province
Baden-württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum Rechts Der Isar, Technische Universität München
City
Munich
State/Province
Bayern
ZIP/Postal Code
80802
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Klinik Für Dermatologie, Venerologie Und Allergologie
City
Frankfurt am main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Fachklinik Bad Bentheim - Dermatologische Studienambulanz
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Facility Name
Dermatologische Studienambulanz
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
University Hospital Muenster
City
Münster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Erlangen Hautklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Pécsi Tudományegyetem Klinikai Központ, Bőr-, Nemikórtani És Onkodermatológiai Klinika
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Facility Name
Szte Áok Szent-Györgyi Albert Klinikai Központ Bőrgyógyászati És Allergológiai Klinika
City
Szeged
State/Province
Csongrád-csanád
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Bugát Pál Kórház
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Semmelweis Egyetem, Általános Orvostudományi Kar, Bőr-, Nemikórtani És Bőronkológiai Klinika
City
Budapest
State/Province
Pest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Wromedica I. Bielicka, A. Strzalkowska S.C.
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-685
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sól
City
Nowa Sól
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Etg Siedlce
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-716
Country
Poland
Facility Name
Rcmed Oddzial Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-892
Country
Poland
Facility Name
Carpe Diem Centrum Medycyny Estetycznej
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-664
Country
Poland
Facility Name
Etg Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Etg Skierniewice
City
Skierniewice
State/Province
Łódzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Hospital Del Mar
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08001
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal - Edificio Consultas Externas
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28081
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

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