Alopecia AreataPhase 2/3NCT03898479
Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
A Phase 2/3 study testing CTP-543 in people with Alopecia Areata, run by Sun Pharmaceutical Industries, Inc. at 91 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- CTP-543
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 91 sitesin 2 countries
- Study dates
- 4 Apr 2019to Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Who cannot join
- 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
Trial locations and contacts
91 sites in 2 countries.
91 sites in 2 countries
United States72 sites
Kern Research Inc.
Bakersfield, California, 93301
Bexley Dermatology Research
Bexley, Ohio, 43209
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35203
Skin Care Research, LLC
Boca Raton, Florida, 33486
ASR, LLC
Boise, Idaho, 83702
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Hope Clinical Research
Canoga Park, California, 91303
Colorado Center for Dermatology, PLLC d/b/a CODerm Research
Centennial, Colorado, 80111
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28211
Darst Dermatology
Charlotte, North Carolina, 28277
University of Virginia Health System
Charlottesville, Virginia, 22903
Denova Research
Chicago, Illinois, 60611
Clarkston Skin Research
Clarkston, Michigan, 48346
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48038
Remington-Davis, Inc.
Columbus, Ohio, 43215
Dermatology Treatment and Research Center - Dallas
Dallas, Texas, 75230
Colorado Medical Research Center
Denver, Colorado, 80210
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Johnson Dermatology
Fort Smith, Arkansas, 72916
Palmetto Clinical Trial Services
Fountain Inn, South Carolina, 29644
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
North Texas Center for Clinical Research
Frisco, Texas, 75034
Skin Laser and Surgery Specialists of NJ
Hackensack, New Jersey, 07601
Skin Care Research, LLC
Hollywood, Florida, 33021
Suzanne Bruce and Associates, PA
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
University of California, Irvine
Irvine, California, 92697
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53144
Vivida Dermatology
Las Vegas, Nevada, 89119
Dermatology Research Associates
Los Angeles, California, 90045
DS Research
Louisville, Kentucky, 40241
University of Miami Hospital
Miami, Florida, 33125
Floridian Research Institute, LLC
Miami, Florida, 33179
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55417
DS Research
New Albany, Indiana, 47150
Yale University Church Street Research Unit
New Haven, Connecticut, 06519
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sadick Research Group
New York, New York, 10075
Quest Dermatology Research
Northridge, California, 91324
Kaiser Permanente Northern California - Oakland
Oakland, California, 94611
Qualmedica Research
Owensboro, Kentucky, 42301
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Hospital of the University of Pennsylvania Dept of Dermatology
Philadelphia, Pennsylvania, 19104
Alliance Dermatology & MOHS Center
Phoenix, Arizona, 85032
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Oregon Medical Research Center
Portland, Oregon, 97201
NW Dermatology Institute
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
North Carolina Dermatology Associates, PLLC
Raleigh, North Carolina, 27617
Stanford University School of Medicine - Medical Dermatology Clinic
Redwood City, California, 94063
West End Dermatology Associates
Richmond, Virginia, 23233
UR Dermatology at College Town
Rochester, New York, 14620
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
Kaiser Permanente South Sacramento
Sacramento, California, 95823
Progressive Clinical Research
San Antonio, Texas, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Kaiser Permanente Clinical Trials Unit
San Francisco, California, 94118
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, 85260
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
ForCare Clinical Research
Tampa, Florida, 33613
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Peak Research - Pennsylvania
Upper Saint Clair, Pennsylvania, 15241
Schweiger Dermatology, P.C.
Verona, New Jersey, 07044
Jordan Valley Dermatology
West Jordan, Utah, 84088
Wake Forest University Health Sciences, Department of Dermatology
Winston-Salem, North Carolina, 27104
Canada19 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T1Y 0B4
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Kingsway Clinical Research
Etobicoke, Ontario, M8X 1Y9
Guelph Dermatology Research
Guelph, Ontario, N1L 0B7
Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7
DermEffects
London, Ontario, N6H 5L5
Lynderm Research Inc.
Markham, Ontario, L3P 1X3
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, L3Y 5G8
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
JRB research Inc.
Ottawa, Ontario, K1K 4L2
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
Québec, G1V 4X7
Care Clinic
Red Deer, Alberta, T4P 1K4
Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
Research Toronto
Toronto, Ontario, M4W 2N4
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
About this study
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
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
- Alopecia Areata
- Being tested
- CTP-543
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTP-543Drug
Twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| CTP-543 | Experimental | Patients who previously completed a qualifying CTP-543 clinical trial Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety
Measured: 332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Measured: 332 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start4 Apr 2019
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898479
- Sponsor's protocol ID
- CP543.5001
- Status last verified
- Oct 2025
- First submitted
- 29 Mar 2019
- Last updated
- 22 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03898479
- Acronym / sponsor ID
- CP543.5001
- Conditions
- Alopecia Areata
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTP-543 | Experimental | Drug: CTP-543Patients who previously completed a qualifying CTP-543 clinical trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTP-543Twice daily dosing | Drug | CTP-543 |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 332 weeks
Effect of CTP-543 on treating hair loss as measured by the Severity of Alopecia Tool (SALT)
Time frame: 332 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CTP-543 in people with Alopecia Areata, run by Sun Pharmaceutical Industries, Inc. at 91 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety (time frame: 332 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.