Alopecia AreataPhase 2NCT04784533
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
A Phase 2 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 39 sites in United States.
Trial summary
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 39 sitesUnited States
- Study dates
- 26 Feb 2021to 16 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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.
- Willing to comply with the study visits and requirements of the study protocol.
Who cannot join
- Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
- Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Kern Research, Inc.
Bakersfield, California, 93301
Bexley Dermatology Research
Bexley, Ohio, 43209
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Skin Care Research, LLC
Boca Raton, Florida, 33486
Hope Clinical Research
Canoga Park, California, 91303
Colorado Center for Dermatology and Skin Surgery
Centennial, Colorado, 80111
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Darst Dermatology
Charlotte, North Carolina, 28277
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
DeNova Research
Chicago, Illinois, 60611
Michigan Center for Research Company, LLC
Clarkston, Michigan, 48346
Remington Davis
Columbus, Ohio, 43215
Dermatology Treatment and Research Center, PA
Dallas, Texas, 75230
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Skin Laser and Surgery Specialists of New Jersey
Hackensack, New Jersey, 07601
Skin Care Research, LLC
Hollywood, Florida, 33021
Austin Institute for Clinical Research
Houston, Texas, 77056
University of California, Irvine
Irvine, California, 92697
DS Research
Louisville, Kentucky, 40241
University of Minnesota Department of Dermatology
Minneapolis, Minnesota, 55455
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Yale University Church Street Research Unit
New Haven, Connecticut, 06519
Quest Dermatology Research
Northridge, California, 91324
Kaiser Permanente
Oakland, California, 94611
Skin Specialists, PC
Omaha, Nebraska, 68144
Palmtree Clinical Research, Inc.
Palm Springs, California, 92262
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Northwest Dermatology
Portland, Oregon, 97210
Rhode Island Hospital
Providence, Rhode Island, 02903
North Carolina Dermatology Associates, PLLC
Raleigh, North Carolina, 27617
West End Dermatology Associates
Richmond, Virginia, 23233
Kaiser Permanente
San Francisco, California, 94118
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, 85260
Springville Dermatology/CCT Research
Springville, Utah, 84663
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, 74136
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241
About this study
Official title: A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.
- Conditions
- Alopecia Areata
- Being tested
- CTP-543, Placebo
- Keywords
- 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
Oral dosing
PlaceboDrug
Oral dosing
| Study group | Role | What they receive |
|---|---|---|
| Part A: Period 1 - CTP-543 8 mg BID | Experimental | Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks. Receives: Drug: CTP-543 |
| Part A: Period 1 - CTP-543 12 mg BID | Experimental | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. Receives: Drug: CTP-543 |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Experimental | Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Experimental | Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
| Part A: Period 2 - CTP-543 8 mg BID to Placebo | Placebo comparator | Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. Receives: Drug: Placebo |
| Part A: Period 2 - CTP-543 12 mg BID to Placebo | Placebo comparator | Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. Receives: Drug: Placebo |
| Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | Experimental | Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
| Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | Experimental | Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Experimental | Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Experimental | Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks. Receives: Drug: CTP-543 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Measured: From Week 24 to Week 48
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Measured: From Week 24 to Week 48
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
Measured: Week 24 of re-treatment
Secondary outcomes (13)
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Measured: Weeks 28, 32, 36, 40, 44, and 48
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20.
Measured: Weeks 28, 32, 36, 40, 44, and 48
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
SPRO is a questionnaire answered by the participant and designed to measure how satisfied alopecia areata participants are with their hair at the time of the assessment. The responses range from 1 to 5: 1= very satisfied, 2= satisfied, 3= neither satisfied nor dissatisfied, 4= dissatisfied, and 5= very dissatisfied. SPRO responder is defined as a post-baseline response of 'very satisfied' or 'satisfied'.
Measured: Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Measured: Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score). Negative change indicates no hair loss.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24
The CGI-I is a questionnaire that asks the clinician to evaluate the improvement or worsening of the participant's alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved).
Measured: Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
The PGI-I is a self-administered questionnaire that asks the participant to evaluate the improvement or worsening of their alopecia areata as compared to the start of the study on a 7-point scale. Responses range from 1 (very much worse) to 7 (very much improved). Responders were defined as participants with responses of 6 (much improved) or 7 (very much improved). PGI responder is a response of 'very much improved' or 'much improved'.
Measured: Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The CGI-S is a questionnaire that asks the clinician to evaluate the symptom severity of the participant's alopecia areata at the time of assessment. The symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Measured: Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
The PGI-S is a self-administered questionnaire that asks the participant to evaluate the symptom severity of their alopecia areata at the time of assessment. Symptom severity was rated on a scale ranging from 1 to 7, where 1=normal, no hair loss; 2=borderline hair loss; 3=mild hair loss; 4=moderate hair loss; 5=marked hair loss; 6=severe hair loss; 7=among the most extreme hair loss. Higher scores indicate more hair loss. A negative change from baseline indicates less hair loss.
Measured: Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
The QPRO questionnaire provides additional details on key attributes of hair and helps provide context to the SPRO response. The individual items of QPRO are: Satisfied thickness hair coverage; Satisfied evenness hair coverage; How satisfied with your eyebrows; How satisfied with your eyelashes, scored on a scale ranging from 1 to 5 where 1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied. Higher scores indicates the greater dissatisfaction on hair quality. A negative change from baseline indicate the greater satisfaction on hair quality.
Measured: Baseline, Weeks 12, 16, 20, and 24
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 during re-treatment.
Measured: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). Relative change (percent change) to baseline is calculated as: 100 x ([post-baseline SALT score - baseline SALT score]/baseline SALT score).
Measured: Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
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. TEAEs were defined as any adverse event that occurs after administration of the first dose of study drug in each Part/Period (ie, on or after the day of the first dose in each Part/Period). TEAEs included both serious and non-serious TEAEs.
Measured: From first dose of study drug up to last follow up visit (Week 76)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start26 Feb 2021
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784533
- Sponsor's protocol ID
- CP543.2004
- Status last verified
- Oct 2024
- First submitted
- 3 Mar 2021
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT04784533
- Acronym / sponsor ID
- CP543.2004
- Conditions
- Alopecia Areata
- Keywords
- CTP-543
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: Period 1 - CTP-543 8 mg BID | Experimental | Drug: CTP-543Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks. |
| Part A: Period 1 - CTP-543 12 mg BID | Experimental | Drug: CTP-543Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks. |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. |
| Part A: Period 2 - CTP-543 8 mg BID to Placebo | Placebo comparator | Drug: PlaceboParticipants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. |
| Part A: Period 2 - CTP-543 12 mg BID to Placebo | Placebo comparator | Drug: PlaceboParticipants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. |
| Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. |
| Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks. |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Experimental | Drug: CTP-543Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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.
- Willing to comply with the study visits and requirements of the study protocol.
Key exclusion criteria (5 listed)
- Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
- Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
- Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
- Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
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-543Oral dosing | Drug | Part A: Period 1 - CTP-543 12 mg BID, Part A: Period 1 - CTP-543 8 mg BID, Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID, Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID, Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID, Part B: CTP-543 12 mg BID to Placebo to 12 mg BID, Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID, Part B: CTP-543 8 mg BID to Placebo to 8 mg BID |
| PlaceboOral dosing | Drug | Part A: Period 2 - CTP-543 12 mg BID to Placebo, Part A: Period 2 - CTP-543 8 mg BID to Placebo |
Primary outcome
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
Time frame: From Week 24 to Week 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
Time frame: From Week 24 to Week 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score >20. The percentage of participants achieving LOM criteria (SALT >20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
Time frame: Week 24 of re-treatment
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
13 secondary outcomes
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48
Time frame: Weeks 28, 32, 36, 40, 44, and 48
Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48
Time frame: Weeks 28, 32, 36, 40, 44, and 48
Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24
Time frame: Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24
Time frame: Weeks 12, 16, 20, and 24
Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24
Time frame: Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Time frame: Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24
Time frame: Baseline, Weeks 12, 16, 20, and 24
Part A, Period 1: Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24
Time frame: Baseline, Weeks 12, 16, 20, and 24
Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24
Time frame: Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to last follow up visit (Week 76)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTP-543 in people with Alopecia Areata, run by Concert Pharmaceuticals at 39 sites in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction (time frame: From Week 24 to Week 48). The study lists 3 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 9 Oct 2024.