Trial · NCT04797650
Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
NCT04797650, Phase 3, Completed, Concert Pharmaceuticals; results first posted 2023-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2). Trials, record NCT04797650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04797650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
- NCT number
- NCT04797650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 517 participants, actual
- Lead sponsor
- Concert Pharmaceuticals
- Conditions
- Alopecia Areata
- Interventions
- CTP-543 matching placebo, CTP-543
- First posted
- 2021-03-15
- Last updated
- 2023-07-03
- Other registries' IDs
- eudract:2021-000387-30
- Results first posted
- 2023-07-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | Week 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). |
| Secondary | Percentage of Responders on the Hair Satisfaction Participants 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. Responders were defined as participants with responses of "satisfied" or "very satisfied". |
| Secondary | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Weeks 4, 8, 12, 16, and 20 | 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). |
| Secondary | 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). |
| Secondary | 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 | 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). |
| Secondary | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, 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. |
| Secondary | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, 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. |
| Secondary | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, 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). Percentage of participants achieving at least a 75% and 90% relative reduction in SALT score from baseline at Weeks 12 and 24 are reported. |
| Secondary | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, and 24 | BETA is a clinician-rated scale that assesses the total eyebrow hair present. The BETA score is calculated based on hair density and surface area of each individual eyebrow of the participant, ranging from 0 to 3, where 0= no eyebrow, 1= minimal eyebrow, 2= moderate eyebrow, and 3= normal eyebrow. The BETA score is the sum of the right and left eyebrow scores, ranging from 0 to 6. Higher scores indicate less hair loss of eyebrows. A positive change from baseline indicates less hair loss of eyebrows. |
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 | Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | Week 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 | Percentage of Responders on the Hair Satisfaction Participants 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 in the study and dispensed study drug during the treatment period. | Percentage of responders | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20 | Weeks 4, 8, 12, 16, and 20 | Efficacy population included all participants who were randomized in the study and dispensed study drug during the treatment period. | percentage of participants | NUMBER |
| SECONDARY | 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 measures. Number of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint. | percentage change | MEAN |
| SECONDARY | 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 in the study and dispensed study drug during the treatment period. | Percentage of responders | NUMBER |
| SECONDARY | 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 in the study and dispensed study drug during the treatment period. | Percentage of responders | NUMBER |
| SECONDARY | Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, Weeks 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint. | Score on a scale | MEAN |
| SECONDARY | Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24 | Baseline, Weeks 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, 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 | Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24 | Baseline, Weeks 12, 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 of participants analyzed indicates the number of participants with data available for analysis at the specified timepoint. | Score on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group234
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 an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | Placebo | 0.8 | Percentage of participants | ||
| Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | CTP-543 8 mg BID | 33.0 | Percentage of participants | ||
| Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24 | CTP-543 12 mg BID | 38.3 | Percentage of participants | ||
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Placebo | Week 12 | 4.9 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | CTP-543 8 mg BID | Week 12 | 43.2 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | CTP-543 12 mg BID | Week 12 | 41.0 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Placebo | Week 16 | 4.9 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | CTP-543 8 mg BID | Week 16 | 41.0 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | CTP-543 12 mg BID | Week 16 | 45.1 | Percentage of responders | |
| Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24 | Placebo | Week 20 | 1.7 | Percentage of responders |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 130 | |
| Overall Study | STARTED | CTP-543 8 mg BID | 258 | |
| Overall Study | STARTED | CTP-543 12 mg BID | 129 | |
| Overall Study | Efficacy Population | Placebo | 127 | |
| Overall Study | Efficacy Population | CTP-543 8 mg BID | 249 | |
| Overall Study | Efficacy Population | CTP-543 12 mg BID | 127 | |
| Overall Study | Safety Population | Placebo | 130 | |
| Overall Study | Safety Population | CTP-543 8 mg BID | 256 | |
| Overall Study | Safety Population | CTP-543 12 mg BID | 129 | |
| Overall Study | COMPLETED | Placebo | 119 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events33
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 | COVID-19 | Infections and infestations | Placebo | 22 | 130 | |
| other | COVID-19 | Infections and infestations | CTP-543 8 mg BID | 60 | 256 | |
| other | COVID-19 | Infections and infestations | CTP-543 12 mg BID | 24 | 129 | |
| other | Asymptomatic COVID-19 | Infections and infestations | Placebo | 22 | 130 | |
| other | Asymptomatic COVID-19 | Infections and infestations | CTP-543 8 mg BID | 33 | 256 | |
| other | Asymptomatic COVID-19 | Infections and infestations | CTP-543 12 mg BID | 21 | 129 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 16 | 130 | |
| other | Nasopharyngitis | Infections and infestations | CTP-543 8 mg BID | 33 | 256 | |
| other | Nasopharyngitis | Infections and infestations | CTP-543 12 mg BID | 16 | 129 | |
| other | Headache | Nervous system disorders | Placebo | 19 | 130 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 130 |
| Total, all-cause mortality | CTP-543 8 mg BID | 0 | 258 |
| Total, all-cause mortality | CTP-543 12 mg BID | 0 | 129 |
| Total, other adverse events | Placebo | 60 | 130 |
| Total, other adverse events | CTP-543 8 mg BID | 137 | 256 |
| Total, other adverse events | CTP-543 12 mg BID | 67 | 129 |
| Total, serious adverse events | Placebo | 0 | 130 |
| Total, serious adverse events | CTP-543 8 mg BID | 3 | 256 |
| Total, serious adverse events | CTP-543 12 mg BID | 2 | 129 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41317911 | DERIVED |
Source PubMed
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/NCT04797650
GET https://conductscience.org/api/trials/v1/NCT04797650/results?page=2