BI 655066 proof of concept dose finding study in AS

Phase 1

Conditions: Ankylosing Spondylitis
MedDRA version: 18.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-003666-13-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

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
- Male patients = 50 years and = 70 years at screening Female patients = 18 years and = 70 years at screening (according to local German protocol amendment 3, EXCLUSION OF MALE PATIENTS < 50 YEARS)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to compare efficacy of BI 655066 versus placebo at 12 weeks, based on ASAS 40 response criteria.;Secondary Objective: To compare efficacy of BI 655066 versus placebo at 24 weeks, based on change in ASDAS score (key secondary)<br>To compare efficacy of BI 655066 versus placebo at 24 weeks, based on ASAS 40 response criteria; To compare efficacy of BI 655066 versus placebo at 24 weeks based on ASAS 20, ASAS 5/6, ASAS remission criteria, change in BASDAI score;Primary end point(s): 1: ASAS 40 response<br>;Timepoint(s) of evaluation of this end point: 1: Week 12<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1: Change in ASDAS score as compared to baseline (Key Secondary)<br><br>2: ASAS 5/6 response<br><br>3: ASAS remission criteria<br><br>4: ASAS 20 response<br><br>5: ASAS 40 response<br><br>6: Change in BASDAI score as compared with baseline<br>;Timepoint(s) of evaluation of this end point: 1: Week 12<br><br>2: Week 12<br><br>3: Week 12<br><br>4: Week 12<br><br>5: Week 24<br><br>6: Week 12<br>