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CTP-543 for Alopecia Areata

Phase-Based Progress Estimates

1

Effectiveness

2

Safety

Alopecia Areata+1 More

CTP-543 - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

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

1

1

1

KX- 826 dosed at 2.5mg

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

1

2

2

KX- 826 dosed at 2.5mg

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 - 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?

Tennessee	100.0%

How old are they?

18 - 65	100.0%

What portion of applicants met pre-screening criteria?

Did not meet criteria	100.0%

References

2021. "A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04784533.

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