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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 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
9%
Acne
6%
Blood creatine phosphokinase (increased)
5%
COVID-19
5%
Nasopharyngitis
3%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Concert PharmaceuticalsLead Sponsor
34 Previous Clinical Trials
4,094 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,902 Patients Enrolled for Alopecia Areata
~69 spots leftby Oct 2025