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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00811499
First received: December 17, 2008
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: ARRY-371797, p38 inhibitor; oral
Drug: Placebo; oral
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Explore potential biomarkers for pharmacodynamics (PD). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
multiple dose, single schedule
Placebo Comparator: Placebo Drug: Placebo; oral
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811499

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

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00811499     History of Changes
Other Study ID Numbers: ARRAY-797-201
Study First Received: December 17, 2008
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on July 23, 2014