Trial · NCT03137381
Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
NCT03137381, Phase 2, Completed, Concert Pharmaceuticals; results first posted 2022-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata. Trials, record NCT03137381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03137381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
- NCT number
- NCT03137381
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 149 participants, actual
- Lead sponsor
- Concert Pharmaceuticals
- Conditions
- Alopecia Areata
- Interventions
- CTP-543, CTP-543 matching placebo
- First posted
- 2017-05-02
- Last updated
- 2022-07-19
- Results first posted
- 2022-07-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24. |
| Primary | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of study drug up to safety follow up at Week 28 | 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. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | Week 24 | Efficacy Population included all participants who received study drug and had at least 1 post-treatment SALT assessment during the treatment period. Participants were analyzed according to their randomized treatment group. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of study drug up to safety follow up at Week 28 | Safety Population included all participants who received study drug during the treatment period. Participants were analyzed according to the actual treatment received during the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | Combined Placebo | 9.3 | Percentage of participants | ||
| Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | Cohort 1: CTP-543 4 mg BID | 21.4 | Percentage of participants | ||
| Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | Cohort 2: CTP-543 8 mg BID | 47.4 | Percentage of participants | ||
| Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24 | Cohort 3: CTP-543 12 mg BID | 58.3 | Percentage of participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Combined Placebo | 31 | Participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Cohort 1: CTP-543 4 mg BID | 25 | Participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Cohort 2: CTP-543 8 mg BID | 31 | Participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Cohort 3: CTP-543 12 mg BID | 30 | Participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined Placebo | 44 | |
| Overall Study | STARTED | Cohort 1: CTP-543 4 mg BID | 30 | |
| Overall Study | STARTED | Cohort 2: CTP-543 8 mg BID | 38 | |
| Overall Study | STARTED | Cohort 3: CTP-543 12 mg BID | 37 | |
| Overall Study | Safety Population | Combined Placebo | 44 | |
| Overall Study | Safety Population | Cohort 1: CTP-543 4 mg BID | 29 | |
| Overall Study | Safety Population | Cohort 2: CTP-543 8 mg BID | 38 | |
| Overall Study | Safety Population | Cohort 3: CTP-543 12 mg BID | 36 | |
| Overall Study | COMPLETED | Combined Placebo | 35 | |
| Overall Study | COMPLETED | Cohort 1: CTP-543 4 mg BID | 23 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events160
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 | Upper respiratory tract infection | Infections and infestations | Combined Placebo | 7 | 44 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 1: CTP-543 4 mg BID | 2 | 29 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 2: CTP-543 8 mg BID | 2 | 38 | |
| other | Upper respiratory tract infection | Infections and infestations | Cohort 3: CTP-543 12 mg BID | 7 | 36 | |
| other | Nasopharyngitis | Infections and infestations | Combined Placebo | 1 | 44 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 1: CTP-543 4 mg BID | 3 | 29 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 2: CTP-543 8 mg BID | 3 | 38 | |
| other | Nasopharyngitis | Infections and infestations | Cohort 3: CTP-543 12 mg BID | 9 | 36 | |
| other | Folliculitis | Infections and infestations | Combined Placebo | 0 | 44 | |
| other | Folliculitis | Infections and infestations | Cohort 1: CTP-543 4 mg BID | 3 | 29 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Placebo | 0 | 44 |
| Total, all-cause mortality | Cohort 1: CTP-543 4 mg BID | 0 | 29 |
| Total, all-cause mortality | Cohort 2: CTP-543 8 mg BID | 0 | 38 |
| Total, all-cause mortality | Cohort 3: CTP-543 12 mg BID | 0 | 36 |
| Total, other adverse events | Combined Placebo | 31 | 44 |
| Total, other adverse events | Cohort 1: CTP-543 4 mg BID | 25 | 29 |
| Total, other adverse events | Cohort 2: CTP-543 8 mg BID | 31 | 38 |
| Total, other adverse events | Cohort 3: CTP-543 12 mg BID | 30 | 36 |
| Total, serious adverse events | Combined Placebo | 0 | 44 |
| Total, serious adverse events | Cohort 1: CTP-543 4 mg BID | 0 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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/NCT03137381
GET https://conductscience.org/api/trials/v1/NCT03137381/events?page=2