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

Recruiting at 38 trial locations

Overseen By Colleen E. Hamilton, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Concert Pharmaceuticals

Must not be taking: Immunosuppressives, Biologics

Disqualifiers: Psoriasis, Pregnancy, Psychiatric disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

317 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that may affect hair regrowth or immune response within 1 month of starting the study. Additionally, you must not take systemic immunosuppressive medications within 3 months or biologics within 6 months of starting the study.

What is the purpose of this trial?

This trial is testing a medication called CTP-543 to see if it can help adults with moderate to severe alopecia areata regrow their hair. The study will also check if the hair continues to grow when the dose of the medication is reduced. The goal is to find an effective treatment for significant hair loss.

Eligibility Criteria

Inclusion Criteria

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.

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.

Exclusion Criteria

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.

You cannot take any medication or treatment that may affect hair growth or your immune system 1 month before or during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A, Period 1

Participants receive CTP-543 8 mg or 12 mg tablets, orally, BID for up to 24 weeks

24 weeks

Treatment Part A, Period 2

Participants receive dose reduction or placebo for up to 24 weeks

24 weeks

Treatment Part B

Participants who met LOM criteria receive re-treatment with CTP-543 for up to 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CTP-543

Participant Groups

Group I: Part B: CTP-543 8 mg BID to Placebo to 8 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.

Group II: Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.

Group III: Part B: CTP-543 12 mg BID to Placebo to 12 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.

Group IV: Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.

Group V: Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.

Group VI: Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID Experimental Treatment 1 Intervention

Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.

Group VII: Part A: Period 1 - CTP-543 8 mg BID Experimental Treatment 1 Intervention

Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.

Group VIII: Part A: Period 1 - CTP-543 12 mg BID Experimental Treatment 1 Intervention

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

Group IX: Part A: Period 2 - CTP-543 8 mg BID to Placebo Placebo Group 1 Intervention

Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.

Group X: Part A: Period 2 - CTP-543 12 mg BID to Placebo Placebo Group 1 Intervention

Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.

Who Is Running the Clinical Trial?

Concert Pharmaceuticals

Lead Sponsor

Trials

35

Recruited

4,400+