A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Drug: ARRY-371797, p38 inhibitor; oralDrug: Placebo; oral
- Registration Number
- NCT00811499
- Lead Sponsor
- Pfizer
- Brief Summary
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Diagnosis of ankylosing spondylitis according to the Modified New York Criteria (1984).
- Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance.
- If previously treated with a biological agent, patient must not have failed due to lack of efficacy, and must have completed an appropriate washout period prior to first dose of study drug.
- Patients may continue on specified stable background therapies for ankylosing spondylitis (doses should be stable for at least 4 weeks prior to the first dose of study drug).
- Additional criteria exist.
Key
- Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments.
- Previously treated with intravenous immunoglobulins within 6 months prior to first dose of study drug.
- Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study.
- Trauma or other major surgeries within 8 weeks prior to first dose of study drug.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
- Known positive serology for human immunodeficiency virus (HIV), hepatitis C, and/or hepatitis B.
- Additional criteria exist.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARRY-371797 (Schedule 1) ARRY-371797, p38 inhibitor; oral - ARRY-371797 (Schedule 2) ARRY-371797, p38 inhibitor; oral - ARRY-371797 (Schedule 2) Placebo; oral - Placebo Placebo; oral -
- Primary Outcome Measures
Name Time Method Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20). 12 weeks Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. 12 weeks
- Secondary Outcome Measures
Name Time Method Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. 12 weeks Explore potential biomarkers for pharmacodynamics (PD). 12 weeks
Trial Locations
- Locations (12)
Westroads Medical Group
🇺🇸Omaha, Nebraska, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Low Country Rheumatology
🇺🇸Charleston, South Carolina, United States
Arthritis Northwest
🇺🇸Spokane, Washington, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Rheumatology Research Associates Group
🇨🇦Edmonton, Alberta, Canada
Credit Valley Rheumatology
🇨🇦Mississauga, Ontario, Canada
Center de Recherche Musculo-Squelettique
🇨🇦Trois-Rivieres, Quebec, Canada
University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada