A 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis

Boehringer Ingelheim RCV GmbH & Co KG0 个研究点目标入组 40 人开始时间: 2020年12月8日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•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

•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.

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