BI 655066 proof of concept dose finding study in AS

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2013-003666-13-ES
• Date of registration: 24/10/2013
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim España, S.A.
• Public title: BI 655066 proof of concept dose finding study in AS
• Scientific title: 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. - BI 1311.8
• Date of first enrolment: 26/12/2013
• Target sample size: 212
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003666-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Dose comparison Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Finland, France, Germany, Hong Kong, Italy, Korea, Republic of, Netherlands, Spain, Taiwan, United States

Contacts

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: QRPE PSC CT Information Disclosure
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion criteria

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:
a. BASDAI score (0-10) >= 4, AND
b. Spinal pain level assessed by the 2nd BASDAI question (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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Ankylosing Spondylitis
MedDRA version: 16.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859

Intervention(s)

Product Name: BI 655066 90 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: BI 655066
Other descriptive name: BI 655066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1: week 12

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)
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

Secondary Outcome(s)

Secondary end point(s): 1: Change in ASDAS score at Week 12 as compared to baseline (key secondary)
2: ASAS 5/6 response
3: ASAS remission criteria
4: ASAS 20 response
5: ASAS 40 response
6: Change in BASDAI score as compared to baseline

Timepoint(s) of evaluation of this end point: 1: week 12

2: week 12

3: week 12

4: week 12

5: week 24

6: week 12

Secondary ID(s)

1311.8

Source(s) of Monetary Support

Boehringer Ingelheim España, S.A.