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Trial record 10 of 10 for:    ctp-543

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

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: NCT04518995
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: CTP-543, 8 mg BID Drug: CTP-543, 12 mg BID Drug: Placebo, BID Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CTP-543, 8 mg BID
Oral tablet for 24 weeks
Drug: CTP-543, 8 mg BID
8 mg twice-daily (BID)

Experimental: CTP-543, 12 mg BID
Oral tablet for 24 weeks
Drug: CTP-543, 12 mg BID
12 mg twice-daily (BID)

Placebo Comparator: Placebo, BID
Oral tablet for 24 weeks
Drug: Placebo, BID
Placebo, twice-daily (BID)




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I [ Time Frame: Weeks 12 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.

  5. Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I [ Time Frame: Weeks 12 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.

  6. Change from Baseline in the CGI-S [ Time Frame: Weeks 12 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.

  7. Change from Baseline in the PGI-S [ Time Frame: Weeks 12 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.

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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).



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:

  • 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.

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): NCT04518995


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: NCT04518995    
Other Study ID Numbers: CP543.3001
2020-002704-40 ( EudraCT Number )
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020

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