Ankylosing Spondylitis MedDRA version: 16.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859
Conditions
Interventions
Product Name: BI 655066 90 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 655066
Other descriptive name: BI 65506
Sponsors
Boehringer Ingelheim España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients - Age >= 18 years and == 3 months at screening - Active disease at screening, defined as: a. BASDAI score (0-10) >= 4, AND b. Spinal pain level assessed by the 2nd BASDAI question (0-10) >= 4 (2nd question from BASDAI will be used here) - Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Radiographic evidence of total ankylosis of the spine at screening or before (spinal X-Ray examinations at screening visit/ during screening period are not mandatory - see footnote 12 from Flow-Chart 1). - Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental - Previous or current participation in a clinical trial testing an investigational drug for AS - Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study - Active uveitis or inflammatory bowel disease at screening - Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria - Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to compare efficacy of BI 655066 versus placebo at 12 weeks, based on ASAS 40 response criteria.;Secondary Objective: To compare efficacy of BI 655066 versus placebo at 24 weeks, based on change in ASDAS score (key secondary) To compare efficacy of BI 655066 versus placebo at 24 weeks, based on ASAS 40 response criteria To compare efficacy of BI 655066 versus placebo at 24 weeks based on ASAS 20, ASAS 5/6, ASAS remission criteria, change in BASDAI score;Primary end point(s): 1: ASAS 40 response;Timepoint(s) of evaluation of this end point: 1: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1: week 12 2: week 12 3: week 12 4: week 12 5: week 24 6: week 12;Secondary end point(s): 1: Change in ASDAS score at Week 12 as compared to baseline (key secondary) 2: ASAS 5/6 response 3: ASAS remission criteria 4: ASAS 20 response 5: ASAS 40 response 6: Change in BASDAI score as compared to baseline | — |
Countries
Belgium, Finland, France, Germany, Hong Kong, Italy, Korea, Republic of, Netherlands, Spain, Taiwan, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed