Trial Outcomes & Findings for Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis (NCT NCT00115076)
NCT ID: NCT00115076
Last Updated: 2021-02-08
Results Overview
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
COMPLETED
PHASE3
31 participants
week 12
2021-02-08
Participant Flow
1 patient was not assigned to any arm.
Participant milestones
| Measure |
Psoriasis
moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Psoriasis
n=30 years
moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 12Population: 28 out of 30 participants completed the study. Then clinical improvement was determined only for those 28.
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
Outcome measures
| Measure |
Psoriasis
n=28 Participants
moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
|
|---|---|
|
Number of Participants With Clinical Improvement of Target Lesions
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 0, day 14, day 42, day 84, Days 112, 140, and 168. PASI has been measured at those timepoints but outcome is related to Baseline and Day 84.Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Clinical response defined as PASI improvement over 75% at week 12.
Outcome measures
| Measure |
Psoriasis
n=30 Participants
moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
|
|---|---|
|
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Week 12
|
12.94 score on a scale
Standard Deviation 10.68
|
|
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Baseline
|
34.58 score on a scale
Standard Deviation 17.48
|
Adverse Events
Psoriasis
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psoriasis
n=30 participants at risk
moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
30.0%
9/30 • Number of events 9 • 3 years
|
|
General disorders
fatigue
|
30.0%
9/30 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
diarrhea
|
13.3%
4/30 • Number of events 4 • 3 years
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
20.0%
6/30 • Number of events 6 • 3 years
|
|
General disorders
dizziness
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
urticaria
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
dry mouth
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
aphthous ulcer
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
General disorders
chills
|
13.3%
4/30 • Number of events 4 • 3 years
|
|
General disorders
headache
|
13.3%
4/30 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
nausea
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
General disorders
fever
|
13.3%
4/30 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
abdominal pain
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
2/30 • Number of events 2 • 3 years
|
|
Eye disorders
Conjunctivitis
|
3.3%
1/30 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
vomiting
|
10.0%
3/30 • Number of events 3 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place