Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata

NCT03811912 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CP543.2002
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 10

Brief Summary

This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24

  The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).

  Baseline, Week 24

Secondary Outcomes (4)

• Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline

  Baseline, Weeks 4, 8, 12, 16, 20, and 24

• Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24

  Baseline, Weeks 4, 8, 12, 16, 20, and 24

• Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20

  Baseline, Weeks 4, 8, 12, 16 and 20

• Percentage of Participants With Change in Satisfaction of Hair Coverage

  Baseline, Week 24

Other Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety

  24 Weeks

Study Arms (2)

CTP-543 8 mg BID

EXPERIMENTAL

Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.

Drug: CTP-543; Drug: CTP-543 Matching Placebo

CTP-543 16 mg QD

EXPERIMENTAL

Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.

Drug: CTP-543; Drug: CTP-543 Matching Placebo

Interventions

CTP-543 DRUG

CTP-543 administered as 8 mg tablet.

CTP-543 16 mg QD; CTP-543 8 mg BID

CTP-543 Matching Placebo DRUG

Administered as tablets to aid treatment masking.

CTP-543 16 mg QD; CTP-543 8 mg BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitive diagnosis of alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
• At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
• Clinical lab results within the normal range

You may not qualify if:

• Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
• Treatment with systemic immunosuppressive medications or biologics.
• Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study

Sponsors & Collaborators

• Concert Pharmaceuticals: lead

Study Sites (10)

Investigative Site

Irvine, California, 92697, United States

Location

Investigative Site

San Francisco, California, 94118, United States

Location

Investigative Site

New Haven, Connecticut, 06519, United States

Location

Investigative Site

Boynton Beach, Florida, 33472, United States

Location

Investigative Site

Boston, Massachusetts, 02114, United States

Location

Investigative Site

Boston, Massachusetts, 02115, United States

Location

Investigative Site

Fridley, Minnesota, 55432, United States

Location

Investigative Site

Portsmouth, New Hampshire, 03801, United States

Location

Investigative Site

Winston-Salem, North Carolina, 27104, United States

Location

Investigative Site

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Colleen E. Hamilton
• Organization: Concert Pharmaceuticals, Inc.

AAclinicaltrial_inquiries@concertpharma.com

781-860-0045

Study Officials

• Colleen E Hamilton, MS

  Concert Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: March 21, 2019
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: December 9, 2022
• Results First Posted: December 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)