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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Placebo; oral; Drug: ARRY-371797, p38 inhibitor; oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811499

ARRAY-797-201

C4411006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups, including a placebo group

ARRY-371797 (Schedule 1)

Experimental group

Treatment:

Drug: ARRY-371797, p38 inhibitor; oral

ARRY-371797 (Schedule 2)

Experimental group

Treatment:

Drug: Placebo; oral

Drug: ARRY-371797, p38 inhibitor; oral

Drug: Placebo; oral

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo; oral

Drug: Placebo; oral