---
title: Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
nct_id: NCT03137381
overall_status: COMPLETED
phase: PHASE2
sponsor: Concert Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Alopecia Areata
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03137381.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03137381"
ct_last_update_post_date: 2022-07-19
last_seen_at: "2026-05-12T07:16:24.395Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata

**Official Title:** A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

**NCT ID:** [NCT03137381](https://clinicaltrials.gov/study/NCT03137381)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 149
- **Lead Sponsor:** Concert Pharmaceuticals
- **Conditions:** Alopecia Areata
- **Start Date:** 2017-08-09
- **Completion Date:** 2019-07-08
- **CT.gov Last Update:** 2022-07-19

## Brief Summary

This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.

## Detailed Description

This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Participants will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
```

## Arms

- **Cohort 1: CTP-543 4 mg BID** (EXPERIMENTAL) — Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.
- **Cohort 2: CTP-543 8 mg BID** (EXPERIMENTAL) — Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.
- **Cohort 3: CTP-543 12 mg BID** (EXPERIMENTAL) — Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.
- **Combined Placebo** (PLACEBO_COMPARATOR) — Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.

## Interventions

- **CTP-543** (DRUG) — Administered as tablets.
- **CTP-543 matching placebo** (DRUG) — Administered as tablets.

## Primary Outcomes

- **Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24** _(time frame: 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.
- **Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)** _(time frame: From first dose of study drug up to safety follow up at Week 28)_ — An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.

## Locations (13)

- University of California, Irvine, Irvine, California, United States
- Contour Dermatology & Cosmetic Surgery Center, Rancho Mirage, California, United States
- Stanford University School of Medicine, Redwood City, California, United States
- Kaiser Permanente Northern California, San Francisco, California, United States
- Yale School of Medicine, New Haven, Connecticut, United States
- Siperstein Dermatology Group, Boynton Beach, Florida, United States
- Northwestern University, Chicago, Illinois, United States
- Minnesota Clinical Study Center, Fridley, Minnesota, United States
- Icahn School of Medicine at Mt. Sinai, New York, New York, United States
- Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
- Cleveland Clinic, Cleveland, Ohio, United States
- Northwest Dermatology, Portland, Oregon, United States
- Suzanne Bruce & Associates, PA, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `locations.minnesota clinical study center|fridley|minnesota|united states` — added _(2026-05-12)_
- `locations.icahn school of medicine at mt. sinai|new york|new york|united states` — added _(2026-05-12)_
- `locations.wake forest university health sciences|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of california, irvine|irvine|california|united states` — added _(2026-05-12)_
- `locations.contour dermatology & cosmetic surgery center|rancho mirage|california|united states` — added _(2026-05-12)_
- `locations.stanford university school of medicine|redwood city|california|united states` — added _(2026-05-12)_
- `locations.kaiser permanente northern california|san francisco|california|united states` — added _(2026-05-12)_
- `locations.yale school of medicine|new haven|connecticut|united states` — added _(2026-05-12)_
- `locations.siperstein dermatology group|boynton beach|florida|united states` — added _(2026-05-12)_
- `locations.northwestern university|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.cleveland clinic|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.northwest dermatology|portland|oregon|united states` — added _(2026-05-12)_
- `locations.suzanne bruce & associates, pa|houston|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03137381.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03137381*  
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