CTP-543 for Alopecia Areata

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alopecia Areata+1 More
CTP-543 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Alopecia Areata

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alopecia Areata

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Weeks 4, 8, 12, 16, 20, and 24

24 weeks
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
72 weeks
Number of Participants with Adverse Events (AEs)
Week 12
Part A, Period 1: Change from Baseline in the CGI-S
Part A, Period 1: Change from Baseline in the PGI-S
Part A, Period 1: Change from Baseline on the individual items of the Hair Quality Patient Reported Outcome (QPRO) scale
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the CGI-I
Part A, Period 1: Percentage of responders (defined as "much improved" or "very much improved") using the PGI-I
Part A, Period 1: Percentage of responders (defined as "satisfied" or "very satisfied") on the Hair Satisfaction Patient Reported Outcome (SPRO) scale
Week 4
Part A, Period 1: Relative change in SALT scores from Baseline
Week 4
Part A, Period 1: Relative change in SALT scores from Part B Baseline
Week 4
Percentage of patients achieving loss of maintenance criteria following dose reduction
Percentage of patients achieving loss of maintenance criteria following drug discontinuation
Week 4
Part A, Period 1: Percentage of patients achieving the restoration of regrowth
Week 8
Part A, Period 1: Percentage of patients achieving an absolute SALT score ≤20

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Alopecia Areata

Side Effects for

Cohort 1: CTP-543 4 mg BID
17%Headache
14%Cough
14%Acne
14%Nausea
10%Diarrhea
10%Oropharyngeal pain
10%Blood creatine phosphokinase increased
10%Nasopharyngitis
10%Folliculitis
7%Dermatitis contact
7%Abdominal pain
7%Upper respiratory tract infection
7%Body tinea
7%Viral upper respiratory tract infection
7%Aspartate aminotransferase increased
7%Vomiting
7%Fatigue
3%Sinus congestion
3%Dysgeusia
3%Hemoglobin decreased
3%Influenza
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03137381) in the Cohort 1: CTP-543 4 mg BID ARM group. Side effects include: Headache with 17%, Cough with 14%, Acne with 14%, Nausea with 14%, Diarrhea with 10%.

Trial Design

8 Treatment Groups

Part B - Low dose
1 of 8
Part B - High dose
1 of 8
Part A, Period 2 - Dose reduction from high dose
1 of 8
Part A, Period 1 - High dose
1 of 8
Part A, Period 2 - Dose reduction from low dose
1 of 8
Part A, Period 1 - Low dose
1 of 8
Part A, Period 2 - Drug discontinuation from high dose
1 of 8
Part A, Period 2 - Drug discontinuation from low dose
1 of 8
Experimental Treatment
Non-Treatment Group

300 Total Participants · 8 Treatment Groups

Primary Treatment: CTP-543 · Has Placebo Group · Phase 2

Part B - Low dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part B - High dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part A, Period 2 - Dose reduction from high dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part A, Period 1 - High dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part A, Period 2 - Dose reduction from low dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part A, Period 1 - Low dose
Drug
Experimental Group · 1 Intervention: CTP-543 · Intervention Types: Drug
Part A, Period 2 - Drug discontinuation from high dose
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part A, Period 2 - Drug discontinuation from low dose
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTP-543
2022
Completed Phase 2
~410

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4, 8, 12, 16, 20, and 24

Who is running the clinical trial?

Concert PharmaceuticalsLead Sponsor
34 Previous Clinical Trials
3,987 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,795 Patients Enrolled for Alopecia Areata

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
At least 50% of the scalp is covered in hair, as measured by the SALT score, at Screening and Baseline.
I am willing to comply with the study visits and requirements of the study protocol.
The person has been diagnosed with alopecia areata, which is a condition that results in scalp hair loss

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%