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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 4, 8, 12, 16, 20, and 24
Awards & highlights

Study Summary

This trial is testing a new drug for hair regrowth in people with alopecia areata.

Eligible Conditions
  • Alopecia Areata

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients achieving loss of maintenance criteria defined by SALT following dose reduction
Percentage of patients achieving loss of maintenance criteria defined by SALT following drug discontinuation
Proportion of patients by dose group achieving restoration of regrowth
Secondary outcome measures
Number of Participants with Adverse Events (AEs)
Part A, Period 1: Change from Baseline in the CGI-S
Part A, Period 1: Change from Baseline in the PGI-S
+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
~2110

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for willing participants in this research?

"The clinical trial in question, while no longer recruiting patients, was last updated on 10/28/2022. This is according to information found on clinicaltrials.gov. There are currently 93 other active studies that are enrolling patients."

Answered by AI

Is CTP-543 safe for human use?

"CTP-543 is a Phase 2 drug, meaning that while there is some data supporting its safety, there is no clinical evidence yet of the medication's efficacy. Our team at Power rates it as a 2 on our safety scale."

Answered by AI

How many different medical clinics are participating in this study?

"This study is currently enrolling patients from 40 different locations, including Center for Dermatology and Plastic Surgery/CCT Research in Scottsdale, Arizona, Austin Institute for Clinical Research in Houston, Texas, and Kaiser Permanente in Oakland, California."

Answered by AI

Could I possibly be included as a test subject in this experiment?

"This trial is looking for 300 patients with alopecia areata, between the ages of 18 and 65. Patients must also meet the following 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.."

Answered by AI

Does this research project allow for participants who are over the age of 40?

"The age group of 18 to 65 is eligible for this trial, with 10 other trials offered to those under 18 and 67 options available for seniors."

Answered by AI

What are the most important goals of this research project?

"The primary outcome of this 24-week study, as stated by the trial's sponsor, Concert Pharmaceuticals, will be measuring the Proportion of patients by dose group achieving restoration of regrowth. However, there are also secondary outcomes being assessed which include Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale which is defined as 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., Part A, Period 1:"

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Skin Laser and Surgery Specialists of New Jersey
~76 spots leftby May 2025