Trial · NCT03941548
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
NCT03941548, Phase 2, Completed, Concert Pharmaceuticals; results first posted 2023-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata. Trials, record NCT03941548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03941548
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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 Dosing Regimens of CTP-543 in Adults With Alopecia Areata
- NCT number
- NCT03941548
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Concert Pharmaceuticals
- Conditions
- Alopecia Areata
- Interventions
- CTP-543, CTP-543 Matching Placebo
- First posted
- 2019-05-08
- Last updated
- 2023-04-05
- Results first posted
- 2023-04-05
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% 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 From Baseline in SALT Scores 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 From Baseline in SALT Scores 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 From Baseline | Baseline, Weeks 8, 12 and 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 Weeks 8, 12 and 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 Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 28 weeks | 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. |
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 | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | percent change | MEAN |
| SECONDARY | Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24 | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | score on a scale | MEAN |
| SECONDARY | Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20 | Baseline, Weeks 4, 8, 12, 16 and 20 | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline | Baseline, Weeks 8, 12 and 24 | mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized, with data available for analysis. Number analyzed indicates the number of participants with available data for analysis at the specific timepoint. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 28 weeks | Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group86
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 12 mg BID | 58.44 | Standard Deviation 34.747 | percent change | |
| Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 | CTP-543 24 mg QD | 51.96 | Standard Deviation 37.887 | percent change | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 12 mg BID | 90% Reduction: Week 4 | 0.0 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 24 mg QD | 90% Reduction: Week 4 | 0.0 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 12 mg BID | 90% Reduction: Week 8 | 0.0 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 24 mg QD | 90% Reduction: Week 8 | 0.0 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 12 mg BID | 90% Reduction: Week 12 | 8.8 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 24 mg QD | 90% Reduction: Week 12 | 6.3 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 12 mg BID | 90% Reduction: Week 16 | 20.6 | percentage of participants | |
| Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline | CTP-543 24 mg QD | 90% Reduction: Week 16 | 12.5 | percentage of participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CTP-543 12 mg BID | 34 | |
| Overall Study | STARTED | CTP-543 24 mg QD | 32 | |
| Overall Study | Safety Population | CTP-543 12 mg BID | 34 | |
| Overall Study | Safety Population | CTP-543 24 mg QD | 32 | |
| Overall Study | mITT Population | CTP-543 12 mg BID | 34 | |
| Overall Study | mITT Population | CTP-543 24 mg QD | 32 | |
| Overall Study | COMPLETED | CTP-543 12 mg BID | 33 | |
| Overall Study | COMPLETED | CTP-543 24 mg QD | 30 | |
| Overall Study | NOT COMPLETED | CTP-543 12 mg BID | 1 | |
| Overall Study | NOT COMPLETED | CTP-543 24 mg QD | 2 |
Source ClinicalTrials.gov
Adverse events52
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 | Palpitations | Cardiac disorders | CTP-543 12 mg BID | 0 | 34 | |
| other | Palpitations | Cardiac disorders | CTP-543 24 mg QD | 2 | 32 | |
| other | Dyspepsia | Gastrointestinal disorders | CTP-543 12 mg BID | 2 | 34 | |
| other | Dyspepsia | Gastrointestinal disorders | CTP-543 24 mg QD | 1 | 32 | |
| other | Fatigue | General disorders | CTP-543 12 mg BID | 2 | 34 | |
| other | Fatigue | General disorders | CTP-543 24 mg QD | 1 | 32 | |
| other | Seasonal allergy | General disorders | CTP-543 12 mg BID | 2 | 34 | |
| other | Seasonal allergy | General disorders | CTP-543 24 mg QD | 0 | 32 | |
| other | Folliculitis | General disorders | CTP-543 12 mg BID | 0 | 34 | |
| other | Folliculitis | General disorders | CTP-543 24 mg QD | 3 | 32 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CTP-543 12 mg BID | 0 | 34 |
| Total, all-cause mortality | CTP-543 24 mg QD | 0 | 32 |
| Total, other adverse events | CTP-543 12 mg BID | 28 | 34 |
| Total, other adverse events | CTP-543 24 mg QD | 24 | 32 |
| Total, serious adverse events | CTP-543 12 mg BID | 0 | 34 |
| Total, serious adverse events | CTP-543 24 mg QD | 1 | 32 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CTP-543 12 mg BID vs CTP-543 24 mg QD: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Trial comparisons |
| CTP-543 12 mg BID vs CTP-543 24 mg QD: deaths from any cause | Trial comparisons |
| CTP-543 12 mg BID vs CTP-543 24 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.
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