A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitis

Phase 1

• Conditions: axial spondyloarthritis; MedDRA version: 21.1Level: LLTClassification code 10041672Term: Spondylitis ankylosingSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2019-001684-77-HU
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-08
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified