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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04797650 |
|
Recruitment Status :
Completed
First Posted : March 15, 2021
Last Update Posted : September 29, 2022
|
Sponsor:
Concert Pharmaceuticals
Information provided by (Responsible Party):
Concert Pharmaceuticals
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 517 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 |
| Actual Study Start Date : | May 27, 2021 |
| Actual Primary Completion Date : | June 8, 2022 |
| Actual Study Completion Date : | June 28, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alopecia areata
| 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 :
- 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 :
- 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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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): NCT04797650
Locations
Show 63 study locations
Sponsors and Collaborators
Concert Pharmaceuticals
| Responsible Party: | Concert Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04797650 |
| Other Study ID Numbers: |
CP543.3002 2021-000387-30 ( EudraCT Number ) |
| First Posted: | March 15, 2021 Key Record Dates |
| Last Update Posted: | September 29, 2022 |
| Last Verified: | September 2022 |
| 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:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |