Trial · NCT05041803

European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

NCT05041803, Phase 3, Completed, Sun Pharmaceutical Industries, Inc.; results first posted 2025-11-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata. Trials, record NCT05041803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05041803

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
NCT number: NCT05041803
Status: Completed
Phases: Phase 3
Enrollment: 407 participants, actual
Lead sponsor: Sun Pharmaceutical Industries, Inc.
Conditions: Alopecia Areata
Interventions: CTP-543
First posted: 2021-09-13
Last updated: 2025-11-21
Other registries' IDs: eudract:2021-002365-18
Results first posted: 2025-11-21

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events as a Measure of Safety	108 weeks
Primary	Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	108 weeks	SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100\*(post-baseline value - baseline)/baseline.

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	Number of Participants With Adverse Events as a Measure of Safety	108 weeks	All subjects who received at least 1 dose of CTP-543 in this study. Subjects could be counted in both CTP-543 dose groups due to dose changes.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	108 weeks	Subjects received ≥1 dose of CTP-543 and ≥1 post-baseline SALT score. The 12 mg BID dose was removed per amended protocol; those on it were reduced to 8 mg BID and are shown in the (12→8 mg BID) group. Max 12 mg BID exposure was 81 weeks; by week 108, no subjects remained on it. Participant Flow reflects planned groups based on prior dose (active) or randomization (placebo). Analysis is based on initial treatment, then first new dose if changed.	Percentage change	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Adverse Events as a Measure of Safety	CTP-543 8 mg BID	308		Participants
Number of Participants With Adverse Events as a Measure of Safety	CTP-543 12 mg BID	224		Participants
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	CTP-543 8 mg BID	-96.38	Standard Deviation 8.790	Percentage change
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	CTP-543 8 mg BID to CTP-543 12 mg BID	-88.57	Standard Deviation 18.715	Percentage change
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108	CTP-543 12 mg BID to CTP-543 8 mg BID	-90.25	Standard Deviation 18.860	Percentage change

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CTP-543 8 mg BID	255
Overall Study	STARTED	CTP-543 12 mg BID	152
Overall Study	COMPLETED	CTP-543 8 mg BID	201
Overall Study	COMPLETED	CTP-543 12 mg BID	127
Overall Study	NOT COMPLETED	CTP-543 8 mg BID	54
Overall Study	NOT COMPLETED	CTP-543 12 mg BID	25

Source ClinicalTrials.gov

Adverse events68

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	Headache	Nervous system disorders	CTP-543 8 mg BID	23	367	27
other	Headache	Nervous system disorders	CTP-543 12 mg BID	9	273	10
other	Hypercholesterolaemia	Metabolism and nutrition disorders	CTP-543 8 mg BID	41	367	46
other	Hypercholesterolaemia	Metabolism and nutrition disorders	CTP-543 12 mg BID	29	273	32
other	Anaemia	Blood and lymphatic system disorders	CTP-543 8 mg BID	13	367	16
other	Anaemia	Blood and lymphatic system disorders	CTP-543 12 mg BID	14	273	17
other	Thrombocytosis	Blood and lymphatic system disorders	CTP-543 8 mg BID	20	367	30
other	Thrombocytosis	Blood and lymphatic system disorders	CTP-543 12 mg BID	26	273	28
other	Weight increased	Investigations	CTP-543 8 mg BID	14	367	15
other	Weight increased	Investigations	CTP-543 12 mg BID	14	273	14

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse 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	367
Total, all-cause mortality	CTP-543 12 mg BID	0	273
Total, other adverse events	CTP-543 8 mg BID	176	367
Total, other adverse events	CTP-543 12 mg BID	127	273
Total, serious adverse events	CTP-543 8 mg BID	16	367
Total, serious adverse events	CTP-543 12 mg BID	5	273

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 8 mg BID vs CTP-543 12 mg BID: deaths from any cause	Trial comparisons
CTP-543 8 mg BID vs CTP-543 12 mg BID: Number of Participants With Adverse Events as a Measure of Safety	Trial comparisons
CTP-543 8 mg BID vs CTP-543 12 mg BID: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT05041803

GET https://conductscience.org/api/trials/v1/NCT05041803/events?page=2

API reference For AI assistants