Trial Outcomes & Findings for BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab (NCT NCT02054481)
NCT ID: NCT02054481
Last Updated: 2016-09-19
Results Overview
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2016-09-19
Participant Flow
Participant flow shows disposition at the end of treatment.
Participant milestones
| Measure |
BI 655066 18 mg
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
Stelara
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
1
|
|
Overall Study
STARTED
|
43
|
41
|
42
|
40
|
|
Overall Study
COMPLETED
|
39
|
39
|
40
|
39
|
Reasons for withdrawal
| Measure |
BI 655066 18 mg
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
Stelara
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Other reason
|
2
|
1
|
2
|
0
|
Baseline Characteristics
BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab
Baseline characteristics by cohort
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
49.3 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
44.9 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
45.4 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
45.9 Years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.
Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
|
32.6 Percentage of participants
Interval 19.1 to 48.5
|
73.2 Percentage of participants
Interval 57.1 to 85.8
|
81.0 Percentage of participants
Interval 65.9 to 91.4
|
77.1 Percentage of participants
Interval 66.6 to 85.6
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: FAS
Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Week 12
|
67.4 Percentage of participants
Interval 51.5 to 80.9
|
97.6 Percentage of participants
Interval 87.1 to 99.9
|
90.5 Percentage of participants
Interval 77.4 to 97.3
|
94.0 Percentage of participants
Interval 86.5 to 98.0
|
77.5 Percentage of participants
Interval 61.5 to 89.2
|
|
Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Week 24
|
55.8 Percentage of participants
Interval 39.9 to 70.9
|
92.7 Percentage of participants
Interval 80.1 to 98.5
|
92.9 Percentage of participants
Interval 80.5 to 98.5
|
92.8 Percentage of participants
Interval 84.9 to 97.3
|
70.0 Percentage of participants
Interval 53.5 to 83.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS
Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
|
14.0 Percentage of participants
Interval 5.3 to 27.9
|
41.5 Percentage of participants
Interval 26.3 to 57.9
|
50.0 Percentage of participants
Interval 34.2 to 65.8
|
45.8 Percentage of participants
Interval 34.8 to 57.1
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS
Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
|
93.0 Percentage of participants
Interval 80.9 to 98.5
|
100.0 Percentage of participants
Interval 91.4 to 100.0
|
95.2 Percentage of participants
Interval 83.8 to 99.4
|
97.6 Percentage of participants
Interval 91.6 to 99.7
|
87.5 Percentage of participants
Interval 73.2 to 95.8
|
SECONDARY outcome
Timeframe: Week 24Population: FAS
Percentage of participants who achieved PASI90 at Week 24. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of PASI90 at Week 24
|
30.2 Percentage of participants
Interval 17.2 to 46.1
|
65.9 Percentage of participants
Interval 49.4 to 79.9
|
85.7 Percentage of participants
Interval 71.5 to 94.6
|
75.9 Percentage of participants
Interval 65.3 to 84.6
|
55.0 Percentage of participants
Interval 38.5 to 70.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS including patients with available data.
Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12. PASI score ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
BI 655066 18 mg
n=39 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=41 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=82 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=37 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Percentage Change in PASI Score From Baseline at Week 12
|
-79.7 Percentage of PASI score
Standard Deviation 19.5
|
-93.4 Percentage of PASI score
Standard Deviation 7.7
|
-90.7 Percentage of PASI score
Standard Deviation 23.1
|
-92.1 Percentage of PASI score
Standard Deviation 17.1
|
-82.1 Percentage of PASI score
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Week 12Population: FAS
Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12. sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe).
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Achievement of sPGA Clear or Almost Clear at Week 12
|
62.8 Percentage of participants
Interval 46.7 to 77.0
|
90.2 Percentage of participants
Interval 76.9 to 97.3
|
90.5 Percentage of participants
Interval 77.4 to 97.3
|
90.4 Percentage of participants
Interval 81.9 to 95.7
|
67.5 Percentage of participants
Interval 50.9 to 81.4
|
SECONDARY outcome
Timeframe: From first drug administration until end of follow-up period, up to 48 weeksPopulation: FAS
Time to loss of PASI50 response.
Outcome measures
| Measure |
BI 655066 18 mg
n=43 Participants
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 Participants
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 Participants
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
BI 655066 90+180 mg
n=83 Participants
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
|
Stelara
n=40 Participants
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|---|
|
Time to Loss of PASI50 Response
|
253 Days
Interval 212.0 to 285.0
|
NA Days
Not calculable due to low number of patients with events
|
NA Days
Not calculable due to low number of patients with events
|
NA Days
Not calculable due to low number of patients with events
|
338 Days
Interval 253.0 to
Not calculable due to low number of patients with events
|
Adverse Events
BI 655066 18 mg
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
BI 655066 90 mg
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
BI 655066 180 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Stelara
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BI 655066 18 mg
n=43 participants at risk
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 participants at risk
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 participants at risk
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
Stelara
n=40 participants at risk
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Immune system disorders
Allergy to arthropod bite
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Perineal abscess
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Surgical and medical procedures
Abortion induced
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
Other adverse events
| Measure |
BI 655066 18 mg
n=43 participants at risk
18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
|
BI 655066 90 mg
n=41 participants at risk
90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
|
BI 655066 180 mg
n=42 participants at risk
180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
|
Stelara
n=40 participants at risk
Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight \>100 kg at randomisation.
|
|---|---|---|---|---|
|
Infections and infestations
Folliculitis
|
7.0%
3/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
9.8%
4/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Nasopharyngitis
|
34.9%
15/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
34.1%
14/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
26.2%
11/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
12.5%
5/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.3%
3/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
10.0%
4/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.3%
3/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
4.9%
2/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.1%
3/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
5.0%
2/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
2/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
9.8%
4/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.1%
3/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.5%
3/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Nervous system disorders
Headache
|
11.6%
5/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
4.9%
2/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.1%
3/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
10.0%
4/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.1%
3/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.5%
1/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.0%
3/43 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
2.4%
1/41 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
0.00%
0/42 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
7.5%
3/40 • From first drug administration until 15 weeks after the last drug administration, up to 231 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER