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

Ankylosing Spondylitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00811499
• Other study ID #: ARRAY-797-201
• Secondary ID: C4411006
• Status: Terminated
• Phase: Phase 2
• Start date: December 16, 2008
• Est. completion date: September 29, 2009

Study information

• Verified date: October 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: September 29, 2009
• Est. primary completion date: September 29, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• ARRY-371797, p38 inhibitor; oral
multiple dose, single schedule
• Placebo; oral
matching placebo
• Placebo; oral
multiple dose, single schedule

Locations

Country	Name	City	State
Canada	Rheumatology Research Associates Group	Edmonton	Alberta
Canada	Credit Valley Rheumatology	Mississauga	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Center de Recherche Musculo-Squelettique	Trois-Rivieres	Quebec
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Low Country Rheumatology	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Westroads Medical Group	Omaha	Nebraska
United States	Oregon Health & Science University	Portland	Oregon
United States	Arthritis Northwest	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.		12 weeks
Secondary	Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.		12 weeks
Secondary	Explore potential biomarkers for pharmacodynamics (PD).		12 weeks