Trial Outcomes & Findings for Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects (NCT NCT00658606)
NCT ID: NCT00658606
Last Updated: 2013-01-08
Results Overview
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
COMPLETED
PHASE4
98 participants
Week 16
2013-01-08
Participant Flow
Participant milestones
| Measure |
Alefacept Alone
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
Completed Treatment
|
42
|
44
|
|
Overall Study
COMPLETED
|
33
|
26
|
|
Overall Study
NOT COMPLETED
|
16
|
23
|
Reasons for withdrawal
| Measure |
Alefacept Alone
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
16
|
|
Overall Study
Lack of Compliance
|
0
|
3
|
Baseline Characteristics
Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
Baseline characteristics by cohort
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.2 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
PGA Score
|
3.3 Score
STANDARD_DEVIATION 0.7 • n=5 Participants
|
3.4 Score
STANDARD_DEVIATION 0.6 • n=7 Participants
|
3.3 Score
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
BSA Score
|
21.9 Percentage of BSA
STANDARD_DEVIATION 13.0 • n=5 Participants
|
20.0 Percentage of BSA
STANDARD_DEVIATION 9.4 • n=7 Participants
|
21.0 Percentage of BSA
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
DLQI Score
|
6.1 Score
STANDARD_DEVIATION 10 • n=5 Participants
|
5.9 Score
STANDARD_DEVIATION 7 • n=7 Participants
|
6.1 Score
STANDARD_DEVIATION 9 • n=5 Participants
|
|
PASI Score
|
17.8 Score
STANDARD_DEVIATION 6.0 • n=5 Participants
|
17.5 Score
STANDARD_DEVIATION 5.2 • n=7 Participants
|
17.7 Score
STANDARD_DEVIATION 5.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
|
22.4 Percentage of Subjects
|
44.9 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who completed follow-up were included in this analysis.
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study
|
26.5 Percentage of Subjects
|
36.7 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table.
A negative change from Baseline represents improvement. Change is calculated as Week 16- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
Change from Baseline
|
-8.0 Percentage of BSA
Standard Deviation 14.7
|
-13.4 Percentage of BSA
Standard Deviation 9.2
|
|
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
Baseline
|
21.9 Percentage of BSA
Standard Deviation 13.0
|
20.0 Percentage of BSA
Standard Deviation 9.4
|
|
Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16
Week 16
|
13.9 Percentage of BSA
Standard Deviation 10.8
|
6.6 Percentage of BSA
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table.
A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
Baseline
|
21.9 Percentage of BSA
Standard Deviation 13.0
|
20.0 Percentage of BSA
Standard Deviation 9.4
|
|
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
Week 36
|
14.4 Percentage of BSA
Standard Deviation 14.1
|
8.2 Percentage of BSA
Standard Deviation 8.8
|
|
Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study
Change from Baseline
|
-7.5 Percentage of BSA
Standard Deviation 14.7
|
-11.9 Percentage of BSA
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Week 16Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
PGA Clear or Almost Clear = Yes
|
22.5 Percentage of Subjects
|
42.9 Percentage of Subjects
|
|
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16
PGA Clear or Almost Clear = No
|
77.6 Percentage of Subjects
|
57.1 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The PGA scale is a tool used to evaluate the degree of overall lesion severity. The scale ranges from 0 (clear) to 5 (very severe). Clear is defined as a score of 0; Almost Clear is defined as a score of 1. Subjects who achieved PGA of clear or almost clear at any visit during the study were assigned to the YES category for their respective groups. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
PGA of Clear or Almost Clear = Yes
|
34.7 Percentage of Subjects
|
59.2 Percentage of Subjects
|
|
Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study
PGA of Clear or Almost Clear = No
|
65.3 Percentage of Subjects
|
40.8 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Week 16Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept).
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 90 was defined as an improvement of at least 90% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Percentage of Subjects Who Achieve PASI 90 at Week 16
PASI 90 = Yes
|
8.2 Percentage of Subjects
|
20.4 Percentage of Subjects
|
|
Percentage of Subjects Who Achieve PASI 90 at Week 16
PASI 90 = No
|
91.8 Percentage of Subjects
|
79.6 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who achieved a 75% improvement in PASI and then relapsed were included in the analysis.
The analysis only included subjects who achieved a 75% improvement in PASI and then relapsed. Relapse is defined by a loss of 50% of improvement in PASI.
Outcome measures
| Measure |
Alefacept Alone
n=2 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=2 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Time to Relapse
|
98.0 Days
Standard Deviation 19.8
|
119.0 Days
Standard Deviation 29.7
|
SECONDARY outcome
Timeframe: Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who experienced a 50% decrease in PASI were included in the analysis.
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 50% decrease in PASI were included in the analysis.
Outcome measures
| Measure |
Alefacept Alone
n=29 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=44 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Time for 50% Decrease in PASI
|
84.0 Days
Interval 57.0 to 112.0
|
56.0 Days
Interval 53.5 to 68.5
|
SECONDARY outcome
Timeframe: Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). Only subjects who experienced a 75% decrease in PASI were included in the analysis.
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). Only subjects who experienced 75% decrease in PASI were included in the analysis.
Outcome measures
| Measure |
Alefacept Alone
n=16 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=29 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Time for a 75% Decrease in PASI
|
99.5 Days
Interval 83.0 to 135.0
|
84.0 Days
Interval 56.0 to 87.0
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The number of participants analyzed per arm represents the ITT-Efficacy Population, which consisted of all subjects randomized into the study who received at least one dose of study drug (alefacept). The number of participants per arm is consistent for all categories / rows of the data table.
The DLQI questionnaire is intended to measure how much a subject's skin problem affects the subject's life. Subjects provide answers considering the past week. The scale of the DQLI ranges from 0 (best) to 30 (worst). A negative change from Baseline represents improvement. Change is calculated as Week 36- Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Alefacept Alone
n=49 Participants
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 Participants
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI)
Baseline
|
11.0 DLQI Score
Standard Deviation 6.1
|
9.1 DLQI Score
Standard Deviation 5.9
|
|
Change in Dermatology Life Quality Index (DLQI)
Week 36
|
8.2 DLQI Score
Standard Deviation 7.6
|
5.6 DLQI Score
Standard Deviation 6.7
|
|
Change in Dermatology Life Quality Index (DLQI)
Change from Baseline
|
-2.7 DLQI Score
Standard Deviation 6.5
|
-3.5 DLQI Score
Standard Deviation 6.4
|
Adverse Events
Alefacept Alone
Alefacept + nbUVB
Serious adverse events
| Measure |
Alefacept Alone
n=49 participants at risk
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 participants at risk
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
General disorders
Edema legs
|
0.00%
0/49 • From the time of Informed Consent through the last study visit.
|
2.0%
1/49 • From the time of Informed Consent through the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Cervical disc herniation
|
0.00%
0/49 • From the time of Informed Consent through the last study visit.
|
2.0%
1/49 • From the time of Informed Consent through the last study visit.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/49 • From the time of Informed Consent through the last study visit.
|
2.0%
1/49 • From the time of Informed Consent through the last study visit.
|
Other adverse events
| Measure |
Alefacept Alone
n=49 participants at risk
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
|
Alefacept + nbUVB
n=49 participants at risk
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
|
|---|---|---|
|
Infections and infestations
Common cold
|
2.0%
1/49 • From the time of Informed Consent through the last study visit.
|
6.1%
3/49 • From the time of Informed Consent through the last study visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
2/49 • From the time of Informed Consent through the last study visit.
|
12.2%
6/49 • From the time of Informed Consent through the last study visit.
|
|
Investigations
CD4 lymphocytes decreased
|
20.4%
10/49 • From the time of Informed Consent through the last study visit.
|
14.3%
7/49 • From the time of Informed Consent through the last study visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/49 • From the time of Informed Consent through the last study visit.
|
67.3%
33/49 • From the time of Informed Consent through the last study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/49 • From the time of Informed Consent through the last study visit.
|
10.2%
5/49 • From the time of Informed Consent through the last study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER