## Protocol Section
### Identification Module
**NCT ID:** NCT03898479

**Brief Title:** Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

**Official Title:** A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

#### Organization Study ID Info
**ID:** CP543.5001
#### Organization
**Class:** INDUSTRY
**Full Name:** Concert Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-02

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-04

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2019-04-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-03-29
**Study First Submit QC Date:** 2019-03-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Concert Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.

### Conditions Module

**Conditions:**

- Alopecia Areata

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who previously completed a qualifying CTP-543 clinical trial

**Intervention Names:**

- Drug: CTP-543

**Label:** CTP-543

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CTP-543

**Description:** Twice daily dosing

**Name:** CTP-543

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Participants with Adverse Events as a Measure of Safety

**Time Frame:** 276 weeks

**Measure:** Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)

**Time Frame:** 276 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion Criteria:

* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
* Donation of blood at any point throughout the study and for 30 days after last dose of study medication

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Total Skin and Beauty Dermatology Center

**State:** Alabama

**Zip:** 35203

**Location 2:**

**City:** Phoenix

**Country:** United States

**Facility:** Alliance Dermatology & MOHS Center

**State:** Arizona

**Zip:** 85032

**Location 3:**

**City:** Scottsdale

**Country:** United States

**Facility:** Center for Dermatology and Plastic Surgery/CCT Research

**State:** Arizona

**Zip:** 85260

**Location 4:**

**City:** Fort Smith

**Country:** United States

**Facility:** Johnson Dermatology

**State:** Arkansas

**Zip:** 72916

**Location 5:**

**City:** Rogers

**Country:** United States

**Facility:** Northwest Arkansas Clinical Trials Center, PLLC

**State:** Arkansas

**Zip:** 72758

**Location 6:**

**City:** Bakersfield

**Country:** United States

**Facility:** Kern Research Inc.

**State:** California

**Zip:** 93301

**Location 7:**

**City:** Canoga Park

**Country:** United States

**Facility:** Hope Clinical Research

**State:** California

**Zip:** 91303

**Location 8:**

**City:** Encinitas

**Country:** United States

**Facility:** California Dermatology & Clinical Research Institute

**State:** California

**Zip:** 92024

**Location 9:**

**City:** Irvine

**Country:** United States

**Facility:** University of California, Irvine

**State:** California

**Zip:** 92697

**Location 10:**

**City:** Los Angeles

**Country:** United States

**Facility:** Dermatology Research Associates

**State:** California

**Zip:** 90045

**Location 11:**

**City:** Northridge

**Country:** United States

**Facility:** Quest Dermatology Research

**State:** California

**Zip:** 91324

**Location 12:**

**City:** Oakland

**Country:** United States

**Facility:** Kaiser Permanente Northern California - Oakland

**State:** California

**Zip:** 94611

**Location 13:**

**City:** Palm Springs

**Country:** United States

**Facility:** Palmtree Clinical Research, Inc.

**State:** California

**Zip:** 92262

**Location 14:**

**City:** Redwood City

**Country:** United States

**Facility:** Stanford University School of Medicine - Medical Dermatology Clinic

**State:** California

**Zip:** 94063

**Location 15:**

**City:** Sacramento

**Country:** United States

**Facility:** Kaiser Permanente South Sacramento

**State:** California

**Zip:** 95823

**Location 16:**

**City:** San Francisco

**Country:** United States

**Facility:** Kaiser Permanente Clinical Trials Unit

**State:** California

**Zip:** 94118

**Location 17:**

**City:** Centennial

**Country:** United States

**Facility:** Colorado Center for Dermatology, PLLC d/b/a CODerm Research

**State:** Colorado

**Zip:** 80111

**Location 18:**

**City:** Denver

**Country:** United States

**Facility:** Colorado Medical Research Center

**State:** Colorado

**Zip:** 80210

**Location 19:**

**City:** New Haven

**Country:** United States

**Facility:** Yale University Church Street Research Unit

**State:** Connecticut

**Zip:** 06519

**Location 20:**

**City:** Boca Raton

**Country:** United States

**Facility:** Skin Care Research, LLC

**State:** Florida

**Zip:** 33486

**Location 21:**

**City:** Hollywood

**Country:** United States

**Facility:** Skin Care Research, LLC

**State:** Florida

**Zip:** 33021

**Location 22:**

**City:** Miami

**Country:** United States

**Facility:** University of Miami Hospital

**State:** Florida

**Zip:** 33125

**Location 23:**

**City:** Miami

**Country:** United States

**Facility:** Floridian Research Institute, LLC

**State:** Florida

**Zip:** 33179

**Location 24:**

**City:** Sweetwater

**Country:** United States

**Facility:** Lenus Research & Medical Group, LLC

**State:** Florida

**Zip:** 33172

**Location 25:**

**City:** Tampa

**Country:** United States

**Facility:** Clinical Research Trials of Florida, Inc.

**State:** Florida

**Zip:** 33607

**Location 26:**

**City:** Tampa

**Country:** United States

**Facility:** ForCare Clinical Research

**State:** Florida

**Zip:** 33613

**Location 27:**

**City:** Boise

**Country:** United States

**Facility:** ASR, LLC

**State:** Idaho

**Zip:** 83702

**Location 28:**

**City:** Chicago

**Country:** United States

**Facility:** Denova Research

**State:** Illinois

**Zip:** 60611

**Location 29:**

**City:** Indianapolis

**Country:** United States

**Facility:** Dawes Fretzin Clinical Research Group, LLC

**State:** Indiana

**Zip:** 46250

**Location 30:**

**City:** New Albany

**Country:** United States

**Facility:** DS Research

**State:** Indiana

**Zip:** 47150

**Location 31:**

**City:** Plainfield

**Country:** United States

**Facility:** The Indiana Clinical Trials Center, PC

**State:** Indiana

**Zip:** 46168

**Location 32:**

**City:** Louisville

**Country:** United States

**Facility:** DS Research

**State:** Kentucky

**Zip:** 40241

**Location 33:**

**City:** Owensboro

**Country:** United States

**Facility:** Qualmedica Research

**State:** Kentucky

**Zip:** 42301

**Location 34:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114

**Location 35:**

**City:** Boston

**Country:** United States

**Facility:** Brigham and Women's Hospital

**State:** Massachusetts

**Zip:** 02115

**Location 36:**

**City:** Clarkston

**Country:** United States

**Facility:** Clarkston Skin Research

**State:** Michigan

**Zip:** 48346

**Location 37:**

**City:** Fridley

**Country:** United States

**Facility:** Minnesota Clinical Study Center

**State:** Minnesota

**Zip:** 55432

**Location 38:**

**City:** Minneapolis

**Country:** United States

**Facility:** University of Minnesota Department of Dermatology

**State:** Minnesota

**Zip:** 55417

**Location 39:**

**City:** Las Vegas

**Country:** United States

**Facility:** Vivida Dermatology

**State:** Nevada

**Zip:** 89119

**Location 40:**

**City:** Hackensack

**Country:** United States

**Facility:** Skin Laser and Surgery Specialists of NJ

**State:** New Jersey

**Zip:** 07601

**Location 41:**

**City:** Verona

**Country:** United States

**Facility:** Schweiger Dermatology, P.C.

**State:** New Jersey

**Zip:** 07044

**Location 42:**

**City:** New York

**Country:** United States

**Facility:** Icahn School of Medicine at Mount Sinai

**State:** New York

**Zip:** 10029

**Location 43:**

**City:** New York

**Country:** United States

**Facility:** Sadick Research Group

**State:** New York

**Zip:** 10075

**Location 44:**

**City:** Rochester

**Country:** United States

**Facility:** UR Dermatology at College Town

**State:** New York

**Zip:** 14620

**Location 45:**

**City:** Charlotte

**Country:** United States

**Facility:** Darst Dermatology

**State:** North Carolina

**Zip:** 28277

**Location 46:**

**City:** Charlotte

**Country:** United States

**Facility:** Dermatology Specialists of Charlotte

**State:** North Carolina

**Zip:** 28277

**Location 47:**

**City:** Raleigh

**Country:** United States

**Facility:** North Carolina Dermatology Associates, PLLC

**State:** North Carolina

**Zip:** 27617

**Location 48:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University Health Sciences, Department of Dermatology

**State:** North Carolina

**Zip:** 27104

**Location 49:**

**City:** Bexley

**Country:** United States

**Facility:** Bexley Dermatology Research

**State:** Ohio

**Zip:** 43209

**Location 50:**

**City:** Columbus

**Country:** United States

**Facility:** Remington-Davis, Inc.

**State:** Ohio

**Zip:** 43215

**Location 51:**

**City:** Tulsa

**Country:** United States

**Facility:** Vital Prospects Clinical Research Institute, P.C.

**State:** Oklahoma

**Zip:** 74136

**Location 52:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Medical Research Center

**State:** Oregon

**Zip:** 97201

**Location 53:**

**City:** Portland

**Country:** United States

**Facility:** NW Dermatology Institute

**State:** Oregon

**Zip:** 97210

**Location 54:**

**City:** Philadelphia

**Country:** United States

**Facility:** Hospital of the University of Pennsylvania Dept of Dermatology

**State:** Pennsylvania

**Zip:** 19104

**Location 55:**

**City:** Plymouth Meeting

**Country:** United States

**Facility:** Dermatology Associates of Plymouth Meeting

**State:** Pennsylvania

**Zip:** 19462

**Location 56:**

**City:** Upper Saint Clair

**Country:** United States

**Facility:** Peak Research - Pennsylvania

**State:** Pennsylvania

**Zip:** 15241

**Location 57:**

**City:** East Greenwich

**Country:** United States

**Facility:** Velocity Clinical Research-Providence

**State:** Rhode Island

**Zip:** 02818

**Location 58:**

**City:** Providence

**Country:** United States

**Facility:** Rhode Island Hospital

**State:** Rhode Island

**Zip:** 02903

**Location 59:**

**City:** Charleston

**Country:** United States

**Facility:** Clinical Research Center of the Carolinas

**State:** South Carolina

**Zip:** 29407

**Location 60:**

**City:** Fountain Inn

**Country:** United States

**Facility:** Palmetto Clinical Trial Services

**State:** South Carolina

**Zip:** 29644

**Location 61:**

**City:** Dallas

**Country:** United States

**Facility:** Dermatology Treatment and Research Center - Dallas

**State:** Texas

**Zip:** 75230

**Location 62:**

**City:** Frisco

**Country:** United States

**Facility:** North Texas Center for Clinical Research

**State:** Texas

**Zip:** 75034

**Location 63:**

**City:** Houston

**Country:** United States

**Facility:** Suzanne Bruce and Associates, PA

**State:** Texas

**Zip:** 77056

**Location 64:**

**City:** Pflugerville

**Country:** United States

**Facility:** Austin Institute for Clinical Research, Inc.

**State:** Texas

**Zip:** 78660

**Location 65:**

**City:** San Antonio

**Country:** United States

**Facility:** Progressive Clinical Research

**State:** Texas

**Zip:** 78213

**Location 66:**

**City:** San Antonio

**Country:** United States

**Facility:** Texas Dermatology and Laser Specialists

**State:** Texas

**Zip:** 78218

**Location 67:**

**City:** San Antonio

**Country:** United States

**Facility:** Dermatology Clinical Research Center of San Antonio

**State:** Texas

**Zip:** 78229

**Location 68:**

**City:** West Jordan

**Country:** United States

**Facility:** Jordan Valley Dermatology

**State:** Utah

**Zip:** 84088

**Location 69:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia Health System

**State:** Virginia

**Zip:** 22903

**Location 70:**

**City:** Richmond

**Country:** United States

**Facility:** West End Dermatology Associates

**State:** Virginia

**Zip:** 23233

**Location 71:**

**City:** Kenosha

**Country:** United States

**Facility:** Clinical Investigation Specialists, Inc.

**State:** Wisconsin

**Zip:** 53144

**Location 72:**

**City:** Calgary

**Country:** Canada

**Facility:** Dermatology Research Institute

**State:** Alberta

**Zip:** T1Y 0B4

**Location 73:**

**City:** Calgary

**Country:** Canada

**Facility:** Kirk Barber Research

**State:** Alberta

**Zip:** T2G 1B1

**Location 74:**

**City:** Red Deer

**Country:** Canada

**Facility:** Care Clinic

**State:** Alberta

**Zip:** T4P 1K4

**Location 75:**

**City:** Kelowna

**Country:** Canada

**Facility:** Medical Arts Health Research Group

**State:** British Columbia

**Zip:** V1Y 4N7

**Location 76:**

**City:** Surrey

**Country:** Canada

**Facility:** Enverus Medical Research

**State:** British Columbia

**Zip:** V3V 0C6

**Location 77:**

**City:** Winnipeg

**Country:** Canada

**Facility:** Wiseman Dermatology Research Inc.

**State:** Manitoba

**Zip:** R3M 3Z4

**Location 78:**

**City:** Barrie

**Country:** Canada

**Facility:** SimcoDerm Medical and Surgical Dermatology Center

**State:** Ontario

**Zip:** L4M 7G1

**Location 79:**

**City:** Etobicoke

**Country:** Canada

**Facility:** Kingsway Clinical Research

**State:** Ontario

**Zip:** M8X 1Y9

**Location 80:**

**City:** Guelph

**Country:** Canada

**Facility:** Guelph Dermatology Research

**State:** Ontario

**Zip:** N1L 0B7

**Location 81:**

**City:** London

**Country:** Canada

**Facility:** DermEffects

**State:** Ontario

**Zip:** N6H 5L5

**Location 82:**

**City:** Markham

**Country:** Canada

**Facility:** Lynderm Research Inc.

**State:** Ontario

**Zip:** L3P 1X3

**Location 83:**

**City:** Newmarket

**Country:** Canada

**Facility:** Dr. S. K. Siddha Medicine Professional Corporation

**State:** Ontario

**Zip:** L3Y 5G8

**Location 84:**

**City:** Oakville

**Country:** Canada

**Facility:** The Centre for Clinical Trials

**State:** Ontario

**Zip:** L6J 7W5

**Location 85:**

**City:** Ottawa

**Country:** Canada

**Facility:** JRB research Inc.

**State:** Ontario

**Zip:** K1H 7X3

**Location 86:**

**City:** Richmond Hill

**Country:** Canada

**Facility:** Centre for Dermatology

**State:** Ontario

**Zip:** L4B 1A5

**Location 87:**

**City:** Toronto

**Country:** Canada

**Facility:** Research Toronto

**State:** Ontario

**Zip:** M4W 2N4

**Location 88:**

**City:** Waterloo

**Country:** Canada

**Facility:** Alliance Clinical Trials

**State:** Ontario

**Zip:** N2J 1C4

**Location 89:**

**City:** Montreal

**Country:** Canada

**Facility:** Innovaderm Research Inc.

**State:** Quebec

**Zip:** H2X 2V1

**Location 90:**

**City:** Québec

**Country:** Canada

**Facility:** Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)

**Zip:** G1V 4X7

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007039

- Term: Hypotrichosis

- ID: D000006201

- Term: Hair Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3846

- Name: Alopecia

- Relevance: HIGH

- As Found: Alopecia

- ID: M3847

- Name: Alopecia Areata

- Relevance: HIGH

- As Found: Alopecia Areata

- ID: M10089

- Name: Hypotrichosis

- Relevance: LOW

- As Found: Unknown

- ID: M9293

- Name: Hair Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000505

- Term: Alopecia

- ID: D000000506

- Term: Alopecia Areata

### Misc Info Module

- Version Holder: 2024-05-24
