Ankylosing Spondylitis
Conditions
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.
Interventions
multiple dose, single schedule
DRUGPlacebo; oral
matching placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed