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Trial record 3 of 5 for:    Recruiting Studies | Interventional Studies | Alopecia Areata | United States | Adult | Phase 2 | Industry

A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

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ClinicalTrials.gov Identifier: NCT04784533
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Brief Summary:
This is a two part, double-blind, randomized, multicenter study 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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543 Drug: Placebo Phase 2

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Study Type : Interventional
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A, Period 1 - Low dose
8 mg BID CTP-543 for 24 weeks
Drug: CTP-543
Oral dosing

Experimental: Part A, Period 1 - High dose
12 mg BID CTP-543 for 24 weeks
Drug: CTP-543
Oral dosing

Experimental: Part A, Period 2 - Dose reduction from low dose
Dose reduction for a maximum of 24 weeks for those previously receiving 8 mg BID
Drug: CTP-543
Oral dosing

Placebo Comparator: Part A, Period 2 - Drug discontinuation from low dose
Placebo for a maximum of 24 weeks for those previously receiving 8 mg BID
Drug: Placebo
Oral dosing

Experimental: Part A, Period 2 - Dose reduction from high dose
Dose reduction for a maximum of 24 weeks for those previously receiving 12 mg BID
Drug: CTP-543
Oral dosing

Placebo Comparator: Part A, Period 2 - Drug discontinuation from high dose
Placebo for a maximum of 24 weeks for those previously receiving 12 mg BID
Drug: Placebo
Oral dosing

Experimental: Part B - Low dose
8 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria
Drug: CTP-543
Oral dosing

Experimental: Part B - High dose
12 mg BID CTP-543 for a maximum of 24 weeks for those meeting loss of maintenance criteria
Drug: CTP-543
Oral dosing




Primary Outcome Measures :
  1. Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction [ Time Frame: 24 weeks ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  2. Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation [ Time Frame: 24 weeks ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  3. Proportion of patients by dose group achieving restoration of regrowth [ Time Frame: 24 weeks ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).


Secondary Outcome Measures :
  1. Percentage of patients achieving loss of maintenance criteria following dose reduction [ Time Frame: Weeks 4, 8, 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).

  2. Percentage of patients achieving loss of maintenance criteria following drug discontinuation [ Time Frame: Weeks 4, 8, 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).

  3. Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale [ Time Frame: Weeks 12, 16, 20, and 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.

  4. Part A, Period 1: Percentage of patients achieving an absolute SALT score ≤20 [ Time Frame: Weeks 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).

  5. Part A, Period 1: 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).

  6. Part A, Period 1: 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.

  7. Part A, Period 1: 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.

  8. Part A, Period 1: 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.

  9. Part A, Period 1: 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.

  10. Part A, Period 1: 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.

  11. Part A, Period 1: Percentage of patients achieving the restoration of regrowth [ Time Frame: Weeks 4, 8, 12, 16, and 20 of re-treatment ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  12. Part A, Period 1: Relative change in SALT scores from Part B Baseline [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  13. Number of Participants with Adverse Events (AEs) [ Time Frame: 72 weeks ]
    An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784533


Contacts
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Contact: Colleen E. Hamilton, MS 781-860-0045 AAclinicaltrial_inquiries@concertpharma.com

Locations
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Sponsors and Collaborators
Concert Pharmaceuticals
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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04784533    
Other Study ID Numbers: CP543.2004
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Concert Pharmaceuticals:
CTP-543
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical