Trial · NCT04784533
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
NCT04784533, Phase 2, Completed, Concert Pharmaceuticals; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata. Trials, record NCT04784533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04784533
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
- NCT number
- NCT04784533
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 317 participants, actual
- Lead sponsor
- Concert Pharmaceuticals
- Conditions
- Alopecia Areata
- Interventions
- CTP-543, Placebo
- First posted
- 2021-03-05
- Last updated
- 2024-10-09
- Results first posted
- 2024-10-09
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Primary | Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | 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. |
| Primary | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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'. |
| Secondary | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | 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). |
| Secondary | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, 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. |
| Secondary | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | 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). |
| Secondary | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | 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'. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | From Week 24 to Week 48 | Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| PRIMARY | Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | From Week 24 to Week 48 | Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| PRIMARY | Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Week 24 of re-treatment | Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Weeks 28, 32, 36, 40, 44, and 48 | Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Weeks 28, 32, 36, 40, 44, and 48 | Efficacy Population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Weeks 12, 16, 20, and 24 | Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of participants | NUMBER |
| SECONDARY | Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24 | Weeks 4, 8, 12, 16, 20, and 24 | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Part A, Period 1: Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. Overall number of participants analyzed indicates the number of participants with data available for analysis of this outcome measure. Number analyzed indicates the number of participants with data available for analysis at the specified timepoint. | Percent change | MEAN |
| SECONDARY | Part A, Period 1: Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20 and 24 | Weeks 12, 16, 20, and 24 | Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of responders | NUMBER |
| SECONDARY | Part A, Period 1: Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24 | Weeks 12, 16, 20, and 24 | Efficacy population included all participants who were randomized, dispensed study drug, and had at least 1 post-treatment SALT assessment. | Percentage of responders | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group198
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | 27.8 | 95% Confidence Interval 7.1 to 48.5 | Percentage of participants | |
| 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 | Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | 32.0 | 95% Confidence Interval 13.7 to 50.3 | Percentage of participants | |
| Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | Part A: Period 2 - CTP-543 8 mg BID to Placebo | 83.3 | 95% Confidence Interval 66.1 to 100.0 | Percentage of participants | |
| Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation | Part A: Period 2 - CTP-543 12 mg BID to Placebo | 80.0 | 95% Confidence Interval 64.3 to 95.7 | Percentage of participants | |
| Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | 60.0 | 95% Confidence Interval 17.1 to 100.0 | Percentage of participants | |
| Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | 50.0 | 95% Confidence Interval 15.4 to 84.6 | Percentage of participants | |
| Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | 66.7 | 95% Confidence Interval 54.0 to 99.8 | Percentage of participants | |
| Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24 | Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | 73.7 | 95% Confidence Interval 58.6 to 97.0 | Percentage of participants | |
| 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 | Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Week 28 | 0 | 95% Confidence Interval NA to NA | Percentage of participants |
| 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 | Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Week 28 | 12 | 95% Confidence Interval 2.5 to 31.2 | Percentage of participants |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow100
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 1 - CTP-543 8 mg BID | 180 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 1 - CTP-543 12 mg BID | 137 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 2 - CTP-543 8 mg BID to Placebo | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part A: Period 2 - CTP-543 12 mg BID to Placebo | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | 0 | |
| Part A: Period 1 (Day 1 to Week 24) | STARTED | Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | 0 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 participant flowAdverse events720
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 1 - CTP-543 8 mg BID | 2 | 180 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 1 - CTP-543 12 mg BID | 0 | 137 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | 1 | 18 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | 0 | 25 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 2 - CTP-543 8 mg BID to Placebo | 0 | 18 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part A: Period 2 - CTP-543 12 mg BID to Placebo | 0 | 25 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | 0 | 5 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | 0 | 8 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | 0 | 15 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | 1 | 19 |
1 to 10 of 720Source ClinicalTrials.gov
See all 720 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Period 1 - CTP-543 8 mg BID | 0 | 180 |
| Total, all-cause mortality | Part A: Period 1 - CTP-543 12 mg BID | 0 | 137 |
| Total, all-cause mortality | Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | 0 | 18 |
| Total, all-cause mortality | Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | 0 | 25 |
| Total, all-cause mortality | Part A: Period 2 - CTP-543 8 mg BID to Placebo | 0 | 18 |
| Total, all-cause mortality | Part A: Period 2 - CTP-543 12 mg BID to Placebo | 0 | 25 |
| Total, all-cause mortality | Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | 0 | 5 |
| Total, all-cause mortality | Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | 0 | 8 |
| Total, all-cause mortality | Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | 0 | 15 |
| Total, all-cause mortality | Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | 0 | 19 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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