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JAK Inhibitor

CTP-543 for Alopecia Areata

Phase 2

Waitlist Available

Research Sponsored by Concert Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 28, 32, 36, 40, 44, and 48

Summary

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.

Eligible Conditions

Alopecia Areata

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 28, 32, 36, 40, 44, and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 28, 32, 36, 40, 44, and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 28, 32, 36, 40, 44, and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation

Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction

Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24

Secondary study objectives

Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)

Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24

Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24

+10 more

Side effects data

From 2022 Phase 3 trial • 706 Patients • NCT04518995

12%

Headache

Acne

Blood creatine phosphokinase (increased)

COVID-19

Nasopharyngitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

CTP-543 8 mg BID

CTP-543 12 mg BID

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: CTP-543 8 mg BID to Placebo to 8 mg BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 BIDExperimental Treatment1 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 PlaceboPlacebo Group1 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 PlaceboPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CTP-543

2021

Completed Phase 3

~2520

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