EUCTR2013-003666-13-ITActive, not recruitingPhase 1
A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 212
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Male and female patients
- •-Age >= 18 years and =< 70 years.
- •-Definite AS based on the modified New York criteria (1984)
- •-Documented disease duration > 3 months at screening
- •-Active disease at screening, defined as:
- •--BASDAI score (0-10) >= 4, AND
- •--Spinal pain level assessed by patient on NRS (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
- •-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
Investigators
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