A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis

Study Overview
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Brief Summary
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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.

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Drug: ARRY-371797, p38 inhibitor; oral
* Drug: Placebo; oral
* Drug: Placebo; oral


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-371797 (Schedule 1)<br> | Drug: ARRY-371797, p38 inhibitor; oral<br>* multiple dose, single schedule<br>|
| Experimental: ARRY-371797 (Schedule 2)<br> | Drug: ARRY-371797, p38 inhibitor; oral<br>* multiple dose, single schedule<br>Drug: Placebo; oral<br>* multiple dose, single schedule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo; oral<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |