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

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.

Study Overview

• Status: Terminated
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: ARRY-371797, p38 inhibitor; oral; Drug: Placebo; oral; Drug: Placebo; oral

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5M 0H4
      • Rheumatology Research Associates Group
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • University of Manitoba
  • Ontario
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Rheumatology
  • Quebec
    • Trois-Rivieres, Quebec, Canada, G8Z IY2
      • Center de Recherche Musculo-Squelettique
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • University of Saskatchewan
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Westroads Medical Group
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2008
• Primary Completion (Actual): September 29, 2009
• Study Completion (Actual): September 29, 2009

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 19, 2008

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: ARRAY-797-201; C4411006 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.