axial spondyloarthritis MedDRA version: 21.1 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859
Conditions
Interventions
Product Code: BI 730357
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BI 730357
Current Sponsor code: BI 730357
Other descriptive name: BI 730357
Concentration unit: mg milligram(s)
Con
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients. 2. Age = 18 years and = 75 years at screening visit. 3. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 4. Diagnosis of AS according to modified New York criteria (1984). 5. Documented disease duration = 3 months at screening visit. 6. 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 7. Have either a. an inadequate response for axial symptoms to at least 30 days of optimal daily doses of at least two NSAIDs, OR b. an intolerance to NSAIDs, according to judgement of the investigator. 8. Women of child-bearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the trial and the patient must agree to periodic pregnancy testing during participation in the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Major chronic inflammatory or connective tissue disease other than AS (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, Lyme disease, gout) or fibromyalgia, as assessed by the investigator 2. Active uveitis or uveitis within 4 weeks prior to randomization 3. Suspected or diagnosed inflammatory bowel disease 4. Previous exposure to BI 730357 5. Prior use of any therapeutic agent directly targeted to IL-17 or TNFa 6. Evidence of total ankylosis of the spine at any time in judgement of the investigator 7. Existing contraindications for an MRI examination, according to local medical standards 8. Use of the treatments: - Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation, - non-biologic-targeted synthetic DMARDs (e.g., JAK inhibitors, phosphodiesterase-4 inhibitors or leflunomide with cholestyramine wash-out) within 4 weeks prior to randomization - intraarticular injection(s) (including glucocorticoids) and intramuscular or intraveneous corticosteroid treatment within 4 weeks prior to randomization - oral glucocorticoids within 2 weeks prior to randomization Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to evaluate proof-of-clinical-concept (PoCC) by investigating the efficacy, safety and tolerability of BI 730357 compared to placebo in patients with active AS.;Secondary Objective: Secondary objectives are, amongst others, achievement of low disease activity or inactive disease status at Week 12.;Primary end point(s): 1) Achievement of ASAS 40 ;Timepoint(s) of evaluation of this end point: 1) week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change from baseline to Week 12 in disease activity assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) 2) Achievement of ASAS 20 at Week 12 3) Achievement of Low Disease Activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) 2) at Week 12 as compared to baseline 8) Achievement of ASAS 5/6 at Week 12 9) Number of patients discontinued due to drug-related AEs. 10) AEs 11) Treatment emergent AEs 12) SAEs 13) Intensity (assessed on RCTC criteria) 14) Safety Laboratory Values (haematology, clinical chemistry and urinanalysis) 15) Vital Signs;Timepoint(s) of evaluation of this end point: 1) week 12 2) week 12 3) week 12 4) week 12 5) week 12 6) week 12 7) week 12 8) week 12 9) week 12 10) week 12 11) week 12 12) week 12 13) week 12 14) week 12 15) week 12 | — |
Countries
Belgium, Czechia, Georgia, Germany, Hungary, Korea, Republic of, Moldova, Republic of, Romania, Spain, Ukraine, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH&Co KG
Outcome results
None listed