Trial Outcomes & Findings for Alefacept in Patients With Severe Scalp Alopecia Areata (NCT NCT00167102)
NCT ID: NCT00167102
Last Updated: 2019-05-22
Results Overview
Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-05-22
Participant Flow
Participant milestones
| Measure |
Alefacept
Weekly IM administration of alefacept,15 mg, for 12 weeks, followed by a 12-week, posttreatment observation period.
|
Placebo
Weekly IM administration of placebo, for 12 weeks, followed by a 12-week, posttreatment observation period.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alefacept in Patients With Severe Scalp Alopecia Areata
Baseline characteristics by cohort
| Measure |
Alefacept
n=23 Participants
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
Placebo
n=22 Participants
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
36.3 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksAssess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period in subjects with chronic severe scalp alopecia
Outcome measures
| Measure |
Alefacept
n=23 Participants
Weekly intramuscular administration of alefacept 15mg for 12 weeks
|
Placebo
n=22 Participants
Weekly intramuscular administration of placebo 15 mg for 12 weeks
|
|---|---|---|
|
The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values
|
8.7 percentage of participants
|
13.6 percentage of participants
|
PRIMARY outcome
Timeframe: 24 weeksNumber of any adverse event reported throughout the study, regardless of relation to study drug
Outcome measures
| Measure |
Alefacept
n=23 Participants
Weekly intramuscular administration of alefacept 15mg for 12 weeks
|
Placebo
n=22 Participants
Weekly intramuscular administration of placebo 15 mg for 12 weeks
|
|---|---|---|
|
Number of Adverse Events
|
20 adverse events
|
20 adverse events
|
Adverse Events
Alefacept
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alefacept
n=23 participants at risk
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
Placebo
n=22 participants at risk
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
right elbow arthropathy
|
4.3%
1/23
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/23
|
4.5%
1/22
|
|
Gastrointestinal disorders
vomiting and dehydration
|
0.00%
0/23
|
4.5%
1/22
|
Other adverse events
| Measure |
Alefacept
n=23 participants at risk
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
Placebo
n=22 participants at risk
Weekly IM administration of placebo or 15 mg of alefacept for 12 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
34.8%
8/23
|
9.1%
2/22
|
|
Infections and infestations
Infection
|
17.4%
4/23
|
13.6%
3/22
|
|
Infections and infestations
Cold
|
17.4%
4/23
|
9.1%
2/22
|
|
General disorders
Headaches
|
17.4%
4/23
|
13.6%
3/22
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23
|
4.5%
1/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place