Trial Outcomes & Findings for A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis (NCT NCT00747344)
NCT ID: NCT00747344
Last Updated: 2013-03-29
Results Overview
PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
Week 12
Results posted on
2013-03-29
Participant Flow
Participant milestones
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab 45 mg (CP)
Controlled period (Week 0-12) - Ustekinumab 45 mg Group
|
Placebo -> Ustekinumab 45 mg (After CP)
After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16
|
Ustekinumab 45 mg (After CP)
After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
|
|---|---|---|---|---|
|
Controlled Period
STARTED
|
60
|
61
|
0
|
0
|
|
Controlled Period
COMPLETED
|
55
|
57
|
0
|
0
|
|
Controlled Period
NOT COMPLETED
|
5
|
4
|
0
|
0
|
|
After Controlled Period
STARTED
|
0
|
0
|
55
|
57
|
|
After Controlled Period
COMPLETED
|
0
|
0
|
55
|
56
|
|
After Controlled Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab 45 mg (CP)
Controlled period (Week 0-12) - Ustekinumab 45 mg Group
|
Placebo -> Ustekinumab 45 mg (After CP)
After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16
|
Ustekinumab 45 mg (After CP)
After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
|
|---|---|---|---|---|
|
Controlled Period
Adverse Event
|
3
|
0
|
0
|
0
|
|
Controlled Period
Lack of Efficacy
|
2
|
1
|
0
|
0
|
|
Controlled Period
Other
|
0
|
3
|
0
|
0
|
|
After Controlled Period
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 3 Trial to Look at the Safety and Effectiveness of Ustekinumab in Korean and Taiwanese Subjects With Moderate to Severe Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (CP)
n=60 Participants
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab 45 mg (CP)
n=61 Participants
Controlled period (Week 0-12) - Ustekinumab 45 mg Group
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.4 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 12.66 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Region of Enrollment
Republic of Korea
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.
PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Outcome measures
| Measure |
Placebo
n=60 Participants
|
Ustekinumab 45 mg
n=61 Participants
|
|---|---|---|
|
The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12
|
3 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.
Outcome measures
| Measure |
Placebo
n=60 Participants
|
Ustekinumab 45 mg
n=61 Participants
|
|---|---|---|
|
The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
|
5 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.
Scores could range from 0 to 30. A lower DLQI score represents better quality of life.
Outcome measures
| Measure |
Placebo
n=60 Participants
|
Ustekinumab 45 mg
n=61 Participants
|
|---|---|---|
|
The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12
|
-0.5 Scores on a scale
Standard Deviation 6.51
|
-11.2 Scores on a scale
Standard Deviation 7.07
|
Adverse Events
Placebo (CP)
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Ustekinumab 45 mg (CP)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo -> Ustekinumab 45 mg (After CP)
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Ustekinumab 45 mg (After CP)
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=60 participants at risk
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab 45 mg (CP)
n=61 participants at risk
Controlled period (Week 0-12) - Ustekinumab 45 mg Group
|
Placebo -> Ustekinumab 45 mg (After CP)
n=55 participants at risk
After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16
|
Ustekinumab 45 mg (After CP)
n=59 participants at risk
After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
|
|---|---|---|---|---|
|
Infections and infestations
Anal abscess
|
1.7%
1/60
|
0.00%
0/61
|
0.00%
0/55
|
0.00%
0/59
|
|
Infections and infestations
Appendicitis
|
0.00%
0/60
|
0.00%
0/61
|
3.6%
2/55
|
0.00%
0/59
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/60
|
0.00%
0/61
|
1.8%
1/55
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/60
|
0.00%
0/61
|
0.00%
0/55
|
1.7%
1/59
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/60
|
0.00%
0/61
|
1.8%
1/55
|
0.00%
0/59
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/60
|
0.00%
0/61
|
1.8%
1/55
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/60
|
0.00%
0/61
|
0.00%
0/55
|
1.7%
1/59
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.7%
1/60
|
0.00%
0/61
|
0.00%
0/55
|
0.00%
0/59
|
Other adverse events
| Measure |
Placebo (CP)
n=60 participants at risk
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab 45 mg (CP)
n=61 participants at risk
Controlled period (Week 0-12) - Ustekinumab 45 mg Group
|
Placebo -> Ustekinumab 45 mg (After CP)
n=55 participants at risk
After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\> receiving ustekinumab 45 mg at Week 12 and Week 16
|
Ustekinumab 45 mg (After CP)
n=59 participants at risk
After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60
|
1.6%
1/61
|
5.5%
3/55
|
1.7%
1/59
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.3%
2/60
|
3.3%
2/61
|
1.8%
1/55
|
5.1%
3/59
|
|
General disorders
Injection site erythema
|
5.0%
3/60
|
0.00%
0/61
|
1.8%
1/55
|
0.00%
0/59
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.3%
2/60
|
0.00%
0/61
|
7.3%
4/55
|
8.5%
5/59
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
3/60
|
8.2%
5/61
|
5.5%
3/55
|
13.6%
8/59
|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
7/60
|
11.5%
7/61
|
3.6%
2/55
|
8.5%
5/59
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
5/60
|
8.2%
5/61
|
5.5%
3/55
|
5.1%
3/59
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
5.0%
3/60
|
0.00%
0/61
|
0.00%
0/55
|
0.00%
0/59
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
3/60
|
6.6%
4/61
|
3.6%
2/55
|
0.00%
0/59
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/60
|
0.00%
0/61
|
3.6%
2/55
|
5.1%
3/59
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.7%
16/60
|
8.2%
5/61
|
3.6%
2/55
|
6.8%
4/59
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
8.3%
5/60
|
3.3%
2/61
|
5.5%
3/55
|
5.1%
3/59
|
Additional Information
Director, Clinical Research
Janssen Research & Development, LLC
Phone: 215-793-7646
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60