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BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054481
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: BI 655066
Drug: Ustekinumab
Enrollment 166
Recruitment Details  
Pre-assignment Details Participant flow shows disposition at the end of treatment.
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara
Hide Arm/Group Description 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. 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. 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 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.
Period Title: Overall Study
Started 43 41 42 40
Completed 39 39 40 39
Not Completed 4 2 2 1
Reason Not Completed
Adverse Event             1             1             0             1
Lost to Follow-up             1             0             0             0
Other reason             2             1             2             0
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara Total
Hide Arm/Group Description 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. 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. 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 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 of all reporting groups
Overall Number of Baseline Participants 43 41 42 40 166
Hide Baseline Analysis Population Description
Safety Set (SAF) which Included all randomised patients who received at least 1 dose of trial medication and was based on the first treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 41 participants 42 participants 40 participants 166 participants
44.1  (14.2) 49.3  (13.3) 44.9  (14.0) 45.4  (12.1) 45.9  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 41 participants 42 participants 40 participants 166 participants
Female
20
  46.5%
11
  26.8%
13
  31.0%
13
  32.5%
57
  34.3%
Male
23
  53.5%
30
  73.2%
29
  69.0%
27
  67.5%
109
  65.7%
1.Primary Outcome
Title Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12
Hide Description

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).

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
32.6
(19.1 to 48.5)
73.2
(57.1 to 85.8)
81.0
(65.9 to 91.4)
77.1
(66.6 to 85.6)
40.0
(24.9 to 56.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 36.4
Confidence Interval (2-Sided) 95%
19.0 to 53.8
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
2.Secondary Outcome
Title Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24
Hide Description

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).

Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 12
67.4
(51.5 to 80.9)
97.6
(87.1 to 99.9)
90.5
(77.4 to 97.3)
94.0
(86.5 to 98.0)
77.5
(61.5 to 89.2)
Week 24
55.8
(39.9 to 70.9)
92.7
(80.1 to 98.5)
92.9
(80.5 to 98.5)
92.8
(84.9 to 97.3)
70.0
(53.5 to 83.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0355
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
1.0 to 28.2
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 21.1
Confidence Interval (2-Sided) 95%
6.0 to 36.2
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
3.Secondary Outcome
Title Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12
Hide Description

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).

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.0
(5.3 to 27.9)
41.5
(26.3 to 57.9)
50.0
(34.2 to 65.8)
45.8
(34.8 to 57.1)
17.5
(7.3 to 32.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
11.3 to 42.9
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
4.Secondary Outcome
Title Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12
Hide Description

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).

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
93.0
(80.9 to 98.5)
100.0
(91.4 to 100.0)
95.2
(83.8 to 99.4)
97.6
(91.6 to 99.7)
87.5
(73.2 to 95.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0706
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 10.1
Confidence Interval (2-Sided) 95%
-0.8 to 21.1
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
5.Secondary Outcome
Title Achievement of PASI90 at Week 24
Hide Description

Percentage of participants who achieved PASI90 at Week 24.

PASI score ranges from 0 (best) to 72 (worst).

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.2
(17.2 to 46.1)
65.9
(49.4 to 79.9)
85.7
(71.5 to 94.6)
75.9
(65.3 to 84.6)
55.0
(38.5 to 70.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0300
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
1.9 to 37.7
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
6.Secondary Outcome
Title Percentage Change in PASI Score From Baseline at Week 12
Hide Description

Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.

PASI score ranges from 0 (best) to 72 (worst).

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS including patients with available data.
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 39 41 41 82 37
Mean (Standard Deviation)
Unit of Measure: Percentage of PASI score
-79.7  (19.5) -93.4  (7.7) -90.7  (23.1) -92.1  (17.1) -82.1  (19.5)
7.Secondary Outcome
Title Achievement of sPGA Clear or Almost Clear at Week 12
Hide Description

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).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
62.8
(46.7 to 77.0)
90.2
(76.9 to 97.3)
90.5
(77.4 to 97.3)
90.4
(81.9 to 95.7)
67.5
(50.9 to 81.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0072
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
5.7 to 36.6
Estimation Comments Difference calculated as BI 90+180 mg minus Stelara
8.Secondary Outcome
Title Time to Loss of PASI50 Response
Hide Description Time to loss of PASI50 response.
Time Frame From first drug administration until end of follow-up period, up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg BI 655066 90+180 mg Stelara
Hide Arm/Group Description:
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.
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.
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.
90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
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 Number of Participants Analyzed 43 41 42 83 40
Median (95% Confidence Interval)
Unit of Measure: Days
253
(212 to 285)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
338 [1] 
(253 to NA)
[1]
Not calculable due to low number of patients with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BI 655066 90+180 mg, Stelara
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.1844
Confidence Interval (2-Sided) 95%
0.1 to 0.4
Estimation Comments [Not Specified]
Time Frame From first drug administration until 15 weeks after the last drug administration, up to 231 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara
Hide Arm/Group Description 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. 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. 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 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.
All-Cause Mortality
BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/43 (11.63%)   6/41 (14.63%)   0/42 (0.00%)   3/40 (7.50%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Coronary artery occlusion  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Immune system disorders         
Allergy to arthropod bite  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Infections and infestations         
Bronchitis  1  0/43 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Diverticulitis  1  0/43 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Perineal abscess  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Urinary tract infection  1  0/43 (0.00%)  0/41 (0.00%)  0/42 (0.00%)  1/40 (2.50%) 
Injury, poisoning and procedural complications         
Pelvic fracture  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Rib fracture  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  1/43 (2.33%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Salivary gland neoplasm  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/43 (0.00%)  1/41 (2.44%)  0/42 (0.00%)  0/40 (0.00%) 
Headache  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Transient ischaemic attack  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders         
Erythema multiforme  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Surgical and medical procedures         
Abortion induced  1  1/43 (2.33%)  0/41 (0.00%)  0/42 (0.00%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BI 655066 18 mg BI 655066 90 mg BI 655066 180 mg Stelara
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/43 (53.49%)   22/41 (53.66%)   20/42 (47.62%)   17/40 (42.50%) 
Infections and infestations         
Folliculitis  1  3/43 (6.98%)  1/41 (2.44%)  1/42 (2.38%)  0/40 (0.00%) 
Gastroenteritis  1  1/43 (2.33%)  4/41 (9.76%)  0/42 (0.00%)  0/40 (0.00%) 
Nasopharyngitis  1  15/43 (34.88%)  14/41 (34.15%)  11/42 (26.19%)  5/40 (12.50%) 
Rhinitis  1  0/43 (0.00%)  3/41 (7.32%)  1/42 (2.38%)  1/40 (2.50%) 
Sinusitis  1  1/43 (2.33%)  0/41 (0.00%)  1/42 (2.38%)  4/40 (10.00%) 
Upper respiratory tract infection  1  0/43 (0.00%)  3/41 (7.32%)  1/42 (2.38%)  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/43 (2.33%)  2/41 (4.88%)  3/42 (7.14%)  2/40 (5.00%) 
Back pain  1  2/43 (4.65%)  4/41 (9.76%)  1/42 (2.38%)  1/40 (2.50%) 
Myalgia  1  0/43 (0.00%)  1/41 (2.44%)  3/42 (7.14%)  3/40 (7.50%) 
Nervous system disorders         
Headache  1  5/43 (11.63%)  2/41 (4.88%)  3/42 (7.14%)  4/40 (10.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  1/43 (2.33%)  1/41 (2.44%)  3/42 (7.14%)  1/40 (2.50%) 
Psoriasis  1  3/43 (6.98%)  1/41 (2.44%)  0/42 (0.00%)  3/40 (7.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02054481    
Other Study ID Numbers: 1311.2
2012-004384-48 ( EudraCT Number: EudraCT )
First Submitted: February 3, 2014
First Posted: February 4, 2014
Results First Submitted: July 29, 2016
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016