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.

Boehringer Ingelheim0 sites212 target enrollmentNovember 11, 2013

Overview

No summary available.

Registry

who.int

Start Date

November 11, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-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

•\-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