BI 655066 proof of concept dose finding study in AS

Phase 1

• Conditions: Ankylosing Spondylitis; MedDRA version: 16.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-003666-13-IT
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-11
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 212

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

Study & Design

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