Trial · NCT03811912
Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
NCT03811912, Phase 2, Completed, Concert Pharmaceuticals; results first posted 2022-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata. Trials, record NCT03811912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03811912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Tolerability Study of Two Dose Regimens of CTP-543 in Adults With Alopecia Areata
- NCT number
- NCT03811912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Concert Pharmaceuticals
- Conditions
- Alopecia Areata
- Interventions
- CTP-543, CTP-543 Matching Placebo
- First posted
- 2019-01-22
- Last updated
- 2022-12-09
- Results first posted
- 2022-12-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline, 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). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score). |
| Secondary | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | Baseline, Weeks 4, 8, 12, 16, 20, and 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). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported. |
| Secondary | Absolute Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 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). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score). |
| Secondary | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Baseline, Weeks 4, 8, 12, 16 and 20 | 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). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score). |
| Secondary | Percentage of Participants With Change in Satisfaction of Hair Coverage | Baseline, Week 24 | Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to the Week 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level. |
| Other | Number of Participants With Adverse Events as a Measure of Safety | 24 Weeks |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline, Week 24 | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | percent change | MEAN |
| SECONDARY | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Percentage of participants | NUMBER |
| SECONDARY | Absolute 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 received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Score on a scale | MEAN |
| SECONDARY | Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20 | Baseline, Weeks 4, 8, 12, 16 and 20 | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Change in Satisfaction of Hair Coverage | Baseline, Week 24 | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment. Participants in the efficacy population were analyzed according to their randomized dosing regimen. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events as a Measure of Safety | 24 Weeks |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | CTP-543 8 mg BID | 46.4 | Standard Deviation 38.21 | percent change | |
| Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | CTP-543 16 mg QD | 18.0 | Standard Deviation 32.32 | percent change | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 8 mg BID | 90% Reduction: Week 4 | 0 | 90% Confidence Interval 0 to 1.7 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 16 mg QD | 90% Reduction: Week 4 | 0 | 90% Confidence Interval 0 to 1.8 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 8 mg BID | 90% Reduction: Week 8 | 0 | 90% Confidence Interval 0 to 1.7 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 16 mg QD | 90% Reduction: Week 8 | 0 | 90% Confidence Interval 0 to 1.8 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 8 mg BID | 90% Reduction: Week 12 | 3.4 | 90% Confidence Interval 0 to 10.7 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 16 mg QD | 90% Reduction: Week 12 | 0 | 90% Confidence Interval 0 to 1.8 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 8 mg BID | 90% Reduction: Week 16 | 6.9 | 90% Confidence Interval 0 to 16.4 | Percentage of participants |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline | CTP-543 16 mg QD | 90% Reduction: Week 16 | 0 | 90% Confidence Interval 0 to 1.8 | Percentage of participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CTP-543 8 mg BID | 29 | |
| Overall Study | STARTED | CTP-543 16 mg QD | 28 | |
| Overall Study | Safety Population | CTP-543 8 mg BID | 29 | |
| Overall Study | Safety Population | CTP-543 16 mg QD | 28 | |
| Overall Study | COMPLETED | CTP-543 8 mg BID | 25 | |
| Overall Study | COMPLETED | CTP-543 16 mg QD | 26 | |
| Overall Study | NOT COMPLETED | CTP-543 8 mg BID | 4 | |
| Overall Study | NOT COMPLETED | CTP-543 16 mg QD | 2 |
Source ClinicalTrials.gov
Adverse events24
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 | Nasopharyngitis | Infections and infestations | CTP-543 8 mg BID | 5 | 29 | |
| other | Nasopharyngitis | Infections and infestations | CTP-543 16 mg QD | 5 | 28 | |
| other | Upper respiratory tract infection | Infections and infestations | CTP-543 8 mg BID | 5 | 29 | |
| other | Upper respiratory tract infection | Infections and infestations | CTP-543 16 mg QD | 3 | 28 | |
| other | Constipation | Gastrointestinal disorders | CTP-543 8 mg BID | 3 | 29 | |
| other | Constipation | Gastrointestinal disorders | CTP-543 16 mg QD | 1 | 28 | |
| other | Nausea | Gastrointestinal disorders | CTP-543 8 mg BID | 2 | 29 | |
| other | Nausea | Gastrointestinal disorders | CTP-543 16 mg QD | 0 | 28 | |
| other | Acne | Skin and subcutaneous tissue disorders | CTP-543 8 mg BID | 4 | 29 | |
| other | Acne | Skin and subcutaneous tissue disorders | CTP-543 16 mg QD | 4 | 28 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CTP-543 8 mg BID | 0 | 29 |
| Total, all-cause mortality | CTP-543 16 mg QD | 0 | 28 |
| Total, other adverse events | CTP-543 8 mg BID | 23 | 29 |
| Total, other adverse events | CTP-543 16 mg QD | 23 | 28 |
| Total, serious adverse events | CTP-543 8 mg BID | 0 | 29 |
| Total, serious adverse events | CTP-543 16 mg QD | 0 | 28 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CTP-543 8 mg BID vs CTP-543 16 mg QD: deaths from any cause | Trial comparisons |
| CTP-543 8 mg BID vs CTP-543 16 mg QD: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03811912
GET https://conductscience.org/api/trials/v1/NCT03811912/results?page=2