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JAK Inhibitor

CTP-543 8 mg BID for Alopecia Areata (THRIVE-AA2 Trial)

Phase 3
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 baseline, weeks 4, 8, 12, 16, 20, and 24
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug called CTP-543 to see if it can help adults who have lost at least half of their scalp hair. The drug works by blocking signals that cause hair loss, which might help hair grow back.

Eligible Conditions
  • Alopecia Areata

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 12, 16, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12, 16, 20, and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
Secondary study objectives
Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24
Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24
Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24
+12 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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CTP-543 8 mg BIDExperimental Treatment1 Intervention
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
Group II: CTP-543 12 mg BIDExperimental Treatment1 Intervention
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants received CTP-543 matched placebo tablets, orally, twice daily (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
3,894 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,702 Patients Enrolled for Alopecia Areata
~117 spots leftby Dec 2025
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