Trial Outcomes & Findings for Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis (NCT NCT00244842)
NCT ID: NCT00244842
Last Updated: 2023-03-27
Results Overview
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
451 participants
Primary outcome timeframe
Twelve Weeks
Results posted on
2023-03-27
Participant Flow
Participant milestones
| Measure |
Placebo 1
Placebo: Placebo
|
ISA247 2
voclosporin: voclosporin 0.2 mg/kg po BID
|
ISA247 3
voclosporin: voclosporin: 0.3 mg/kg po BID
|
ISA247 4
voclosporin: voclosporin: 0.4 mg/kg po BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
115
|
107
|
113
|
116
|
|
Overall Study
COMPLETED
|
92
|
76
|
91
|
83
|
|
Overall Study
NOT COMPLETED
|
23
|
31
|
22
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Placebo
|
Voclosporin: 0.2
n=107 Participants
voclosporin 0.2 mg/kg po BID
|
Voclosporin: 0.3
n=113 Participants
voclosporin 0.3 mg/kg po BID
|
Voclosporin: 0.4
n=116 Participants
voclosporin 0.4 mg/kg po BID
|
Total
n=451 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
451 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
41 years
n=99 Participants
|
42 years
n=107 Participants
|
40 years
n=206 Participants
|
41 years
n=7 Participants
|
41 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
149 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
302 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
115 participants
n=99 Participants
|
107 participants
n=107 Participants
|
113 participants
n=206 Participants
|
116 participants
n=7 Participants
|
451 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Twelve WeeksProportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin.
Outcome measures
| Measure |
Placebo
n=113 Participants
Placebo: Placebo
|
Voclosporin 0.2
n=105 Participants
voclosporin: voclosporin 0.2 mg/kg po BID
|
Voclosporin 0.3
n=111 Participants
voclosporin: voclosporin 0.3 mg/kg po BID
|
Voclosporin 0.4
n=113 Participants
voclosporin: voclosporin 0.4 mg/kg po BID
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin.
|
4 Participants
|
14 Participants
|
26 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Twelve and twenty four weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Twelve and twenty four weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Twelve and twenty four weeksOutcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 62 other events
Deaths: 1 deaths
Voclosporin 0.2
Serious events: 2 serious events
Other events: 67 other events
Deaths: 0 deaths
Voclosporin 0.3
Serious events: 4 serious events
Other events: 65 other events
Deaths: 1 deaths
Voclosporin 0.4
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=115 participants at risk
Placebo: Placebo
|
Voclosporin 0.2
n=107 participants at risk
voclosporin: voclosporin 0.2 mg/kg po BID
|
Voclosporin 0.3
n=113 participants at risk
voclosporin: voclosporin 0.3 mg/kg po BID
|
Voclosporin 0.4
n=116 participants at risk
voclosporin: voclosporin 0.4 mg/kg po BID
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/115
|
0.93%
1/107 • Number of events 1
|
0.00%
0/113
|
0.00%
0/116
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/115
|
0.93%
1/107 • Number of events 1
|
0.00%
0/113
|
0.00%
0/116
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/115
|
0.00%
0/107
|
0.88%
1/113 • Number of events 1
|
0.00%
0/116
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/115
|
0.00%
0/107
|
0.88%
1/113 • Number of events 1
|
0.00%
0/116
|
|
Infections and infestations
Parapharyngeal Abscess
|
0.00%
0/115
|
0.00%
0/107
|
0.88%
1/113 • Number of events 1
|
0.00%
0/116
|
|
General disorders
Accidental Death
|
0.00%
0/115
|
0.00%
0/107
|
0.88%
1/113 • Number of events 1
|
0.00%
0/116
|
|
Psychiatric disorders
Depression
|
0.00%
0/115
|
0.00%
0/107
|
0.00%
0/113
|
0.86%
1/116 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct cancer
|
0.87%
1/115 • Number of events 1
|
0.00%
0/107
|
0.00%
0/113
|
0.00%
0/116
|
|
Psychiatric disorders
Anxiety
|
0.87%
1/115 • Number of events 1
|
0.00%
0/107
|
0.00%
0/113
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.87%
1/115 • Number of events 1
|
0.00%
0/107
|
0.00%
0/113
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
0.87%
1/115 • Number of events 1
|
0.00%
0/107
|
0.00%
0/113
|
0.00%
0/116
|
Other adverse events
| Measure |
Placebo
n=115 participants at risk
Placebo: Placebo
|
Voclosporin 0.2
n=107 participants at risk
voclosporin: voclosporin 0.2 mg/kg po BID
|
Voclosporin 0.3
n=113 participants at risk
voclosporin: voclosporin 0.3 mg/kg po BID
|
Voclosporin 0.4
n=116 participants at risk
voclosporin: voclosporin 0.4 mg/kg po BID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/115 • Number of events 3
|
1.9%
2/107 • Number of events 2
|
3.5%
4/113 • Number of events 4
|
10.3%
12/116 • Number of events 14
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/115 • Number of events 4
|
2.8%
3/107 • Number of events 3
|
1.8%
2/113 • Number of events 2
|
6.0%
7/116 • Number of events 8
|
|
Vascular disorders
Blood pressure increased
|
4.3%
5/115 • Number of events 7
|
3.7%
4/107 • Number of events 4
|
4.4%
5/113 • Number of events 6
|
6.0%
7/116 • Number of events 7
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/115
|
0.00%
0/107
|
0.88%
1/113 • Number of events 1
|
6.0%
7/116 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
6/115 • Number of events 8
|
1.9%
2/107 • Number of events 2
|
2.7%
3/113 • Number of events 3
|
9.5%
11/116 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/115 • Number of events 2
|
4.7%
5/107 • Number of events 5
|
5.3%
6/113 • Number of events 6
|
6.0%
7/116 • Number of events 8
|
|
Nervous system disorders
Headache
|
10.4%
12/115 • Number of events 20
|
16.8%
18/107 • Number of events 22
|
10.6%
12/113 • Number of events 17
|
22.4%
26/116 • Number of events 34
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
23.5%
27/115 • Number of events 32
|
25.2%
27/107 • Number of events 33
|
30.1%
34/113 • Number of events 41
|
22.4%
26/116 • Number of events 32
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
9/115 • Number of events 10
|
11.2%
12/107 • Number of events 14
|
11.5%
13/113 • Number of events 16
|
10.3%
12/116 • Number of events 13
|
|
Vascular disorders
Hypertension
|
6.1%
7/115 • Number of events 10
|
7.5%
8/107 • Number of events 8
|
7.1%
8/113 • Number of events 8
|
10.3%
12/116 • Number of events 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place