Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    THRIVE AA-2
Previous Study | Return to List | Next Study

A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA2) (THRIVE-AA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04797650
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 10, 2021
First Posted Date  ICMJE March 15, 2021
Last Update Posted Date September 13, 2021
Actual Study Start Date  ICMJE May 27, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
Percentage of patients achieving an absolute Severity of Alopecia Tool (SALT) score ≤20 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2021)
  • Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) [ Time Frame: Week 24 ]
    SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
  • Percentage of patients achieving an absolute SALT score of ≤20 [ Time Frame: Weeks 12, 16, and 20 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
  • Relative change in SALT scores from Baseline [ Time Frame: 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).
  • Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Clinician Global Impression of Improvement (CGI-I) is a questionnaire that asks the clinician to evaluate the improvement or worsening of the patient's alopecia areata as compared to the start of the study.
  • Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Patient Global Impression of Improvement (PGI-I) is a self-administered questionnaire that asks the patient to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study.
  • Change from Baseline in the CGI-S [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Clinician Global Impression of Severity (CGI-S) is a questionnaire that asks the clinician to evaluate the severity of the patient's alopecia areata at the time of assessment.
  • Change from Baseline in the PGI-S [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Patient Global Impression of Severity (PGI-S) is a self-administered questionnaire that asks the patient to evaluate the severity of their alopecia areata at the time of assessment.
  • Percentage of patients achieving at least a 75% relative reduction in SALT score from Baseline [ Time Frame: Weeks 12 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).
  • Percentage of patients achieving at least a 90% relative reduction in SALT score from Baseline [ Time Frame: Weeks 12 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).
  • Change from Baseline on an eyebrow score [ Time Frame: Weeks 12 and 24 ]
    A clinician-rated scale that assesses the total eyebrow hair present. The score is derived by assessment of density and surface area of the patient's eyebrows.
  • Change from Baseline on an eyelash score [ Time Frame: Weeks 12 and 24 ]
    A clinician-rated scale that assesses the total eyelash hair present. The score is derived by assessment of density and distribution of the patient's eyelashes.
  • Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome scale [ Time Frame: Weeks 12, 16, and 20 ]
    SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
  • Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale [ Time Frame: 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.
  • Change from Baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 24 ]
    HADS is a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale.
  • Change from Baseline in the anxiety scale of the Hospital Anxiety and Depression Scale [ Time Frame: Week 24 ]
    HADS is a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale.
  • Percentage of patients achieving an absolute SALT score of ≤10 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) [ Time Frame: Week 24 ]
    SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
  • Percentage of patients achieving an absolute SALT score of ≤20 [ Time Frame: Weeks 12, 16, and 20 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
  • Relative change in SALT scores from Baseline [ Time Frame: 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).
  • Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I [ Time Frame: Weeks 12, 16, 20, and 24 ]
    he Clinician Global Impression of Improvement (CGI-I) is a questionnaire that asks the clinician to evaluate the improvement or worsening of the patient's alopecia areata as compared to the start of the study.
  • Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Patient Global Impression of Improvement (PGI-I) is a self-administered questionnaire that asks the patient to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study.
  • Change from Baseline in the CGI-S [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Clinician Global Impression of Severity (CGI-S) is a questionnaire that asks the clinician to evaluate the severity of the patient's alopecia areata at the time of assessment.
  • Change from Baseline in the PGI-S [ Time Frame: Weeks 12, 16, 20, and 24 ]
    The Patient Global Impression of Severity (PGI-S) is a self-administered questionnaire that asks the patient to evaluate the severity of their alopecia areata at the time of assessment.
  • Percentage of patients achieving at least a 75% relative reduction in SALT score from Baseline [ Time Frame: Weeks 12 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).
  • Percentage of patients achieving at least a 90% relative reduction in SALT score from Baseline [ Time Frame: Weeks 12 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).
  • Change from Baseline on an eyebrow score [ Time Frame: Weeks 12 and 24 ]
    A clinician-rated scale that assesses the total eyebrow hair present. The score is derived by assessment of density and surface area of the patient's eyebrows.
  • Change from Baseline on an eyelash score [ Time Frame: Weeks 12 and 24 ]
    A clinician-rated scale that assesses the total eyelash hair present. The score is derived by assessment of density and distribution of the patient's eyelashes.
  • Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome scale [ Time Frame: Weeks 12, 16, and 20 ]
    SPRO is a questionnaire answered by the patient designed to measure how satisfied alopecia areata patients are with their hair at the time of the assessment.
  • Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale [ Time Frame: 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.
  • Change from Baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Week 24 ]
    HADS is a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale.
  • Change from Baseline in the anxiety scale of the Hospital Anxiety and Depression Scale [ Time Frame: Week 24 ]
    HADS is a 14-item measure designed to assess anxiety and depression symptoms in medical patients. Items are rated on a 4-point severity scale.
  • Percentage of patients achieving an absolute SALT score of ≤10 [ Time Frame: 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Official Title  ICMJE 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
Brief Summary This is a multi-center Phase 3 study to evaluate 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. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: CTP-543, 8 mg BID
    8 mg twice-daily (BID)
  • Drug: CTP-543, 12 mg BID
    12 mg twice-daily (BID)
  • Drug: Placebo, BID
    Placebo, twice-daily (BID)
Study Arms  ICMJE
  • Experimental: CTP-543, 8 mg BID
    Oral tablet for 24 weeks
    Intervention: Drug: CTP-543, 8 mg BID
  • Experimental: CTP-543, 12 mg BID
    Oral tablet for 24 weeks
    Intervention: Drug: CTP-543, 12 mg BID
  • Placebo Comparator: Placebo, BID
    Oral tablet for 24 weeks
    Intervention: Drug: Placebo, BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2021)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Colleen E. Hamilton, MS 781-860-0045 AAclinicaltrial_inquiries@concertpharma.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hungary,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04797650
Other Study ID Numbers  ICMJE CP543.3002
2021-000387-30 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Concert Pharmaceuticals
Study Sponsor  ICMJE Concert Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Concert Pharmaceuticals
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP