Trial Outcomes & Findings for European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (NCT NCT05041803)
NCT ID: NCT05041803
Last Updated: 2025-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
108 weeks
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
CTP-543 8 mg BID
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
152
|
|
Overall Study
COMPLETED
|
201
|
127
|
|
Overall Study
NOT COMPLETED
|
54
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Baseline characteristics by cohort
| Measure |
CTP-543 8 mg BID
n=255 Participants
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
n=152 Participants
Participants received CTP-543 12 mg tablets, orally, twice a day
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
193 Participants
n=68 Participants
|
121 Participants
n=76 Participants
|
314 Participants
n=48 Participants
|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 12.41 • n=68 Participants
|
38.2 years
STANDARD_DEVIATION 12.86 • n=76 Participants
|
38.7 years
STANDARD_DEVIATION 12.57 • n=48 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=68 Participants
|
89 Participants
n=76 Participants
|
270 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=68 Participants
|
63 Participants
n=76 Participants
|
137 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=68 Participants
|
5 Participants
n=76 Participants
|
12 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=68 Participants
|
117 Participants
n=76 Participants
|
303 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=68 Participants
|
30 Participants
n=76 Participants
|
92 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
62 Participants
n=68 Participants
|
30 Participants
n=76 Participants
|
92 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 108 weeksPopulation: 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.
Outcome measures
| Measure |
CTP-543 8 mg BID
n=367 Participants
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
n=273 Participants
Participants received CTP-543 12 mg tablets, orally, twice a day
|
CTP-543 12 mg BID to CTP-543 8 mg BID
Participants received CTP-543 12 mg tablets orally, twice daily as the first actual treatment, then 8 mg orally, twice daily as the first dose change.
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety
|
308 Participants
|
224 Participants
|
—
|
PRIMARY outcome
Timeframe: 108 weeksPopulation: 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.
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.
Outcome measures
| Measure |
CTP-543 8 mg BID
n=97 Participants
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
n=48 Participants
Participants received CTP-543 12 mg tablets, orally, twice a day
|
CTP-543 12 mg BID to CTP-543 8 mg BID
n=99 Participants
Participants received CTP-543 12 mg tablets orally, twice daily as the first actual treatment, then 8 mg orally, twice daily as the first dose change.
|
|---|---|---|---|
|
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108
|
-96.38 Percentage change
Standard Deviation 8.790
|
-88.57 Percentage change
Standard Deviation 18.715
|
-90.25 Percentage change
Standard Deviation 18.860
|
Adverse Events
CTP-543 8 mg BID
Serious events: 16 serious events
Other events: 176 other events
Deaths: 0 deaths
CTP-543 12 mg BID
Serious events: 5 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTP-543 8 mg BID
n=367 participants at risk
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
n=273 participants at risk
Participants received CTP-543 12 mg tablets, orally, twice a day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Nervous system disorders
Intracranial hypotension
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Hepatitis E
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Infectious mononucleosis
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Tonsillitis
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Wound infection
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
2/367 • Number of events 2 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Immune system disorders
Anaphylactic reaction
|
0.27%
1/367 • Number of events 2 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/367 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.37%
1/273 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/367 • Number of events 1 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
0.00%
0/273 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
Other adverse events
| Measure |
CTP-543 8 mg BID
n=367 participants at risk
Participants received CTP-543 8 mg tablets, orally, twice a day
|
CTP-543 12 mg BID
n=273 participants at risk
Participants received CTP-543 12 mg tablets, orally, twice a day
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
30/367 • Number of events 50 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
5.1%
14/273 • Number of events 16 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Folliculitis
|
1.1%
4/367 • Number of events 4 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
5.1%
14/273 • Number of events 14 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Investigations
Blood creatine phosphokinase increased
|
11.4%
42/367 • Number of events 53 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
8.8%
24/273 • Number of events 27 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Nervous system disorders
Headache
|
6.3%
23/367 • Number of events 27 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
3.3%
9/273 • Number of events 10 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.2%
41/367 • Number of events 46 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
10.6%
29/273 • Number of events 32 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
13/367 • Number of events 16 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
5.1%
14/273 • Number of events 17 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.4%
20/367 • Number of events 30 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
9.5%
26/273 • Number of events 28 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Investigations
Weight increased
|
3.8%
14/367 • Number of events 15 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
5.1%
14/273 • Number of events 14 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Nasopharyngitis
|
20.7%
76/367 • Number of events 118 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
17.6%
48/273 • Number of events 71 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
Asymptomatic COVID-19
|
22.6%
83/367 • Number of events 92 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
21.2%
58/273 • Number of events 65 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
|
Infections and infestations
COVID-19
|
21.3%
78/367 • Number of events 81 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
16.1%
44/273 • Number of events 46 • 108 Weeks
Subjects could be counted in both CTP-543 dose groups due to dose changes.
|
Additional Information
Head, Regulatory Affairs
Sun Pharmaceutical Industries Limited
Phone: 9122 66455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place