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

December 17, 2008
March 1, 2012
December 2008
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Efficacy of ARRY-371797 as measured by ASAS 20 (Assessments in Ankylosing Spondylitis 20% Working Group response criterion) [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  • Safety of ARRY-371797 as measured by adverse events, findings on physical examinations, laboratory abnormalities, change from baseline in vital sign measurements, and change from baseline in 12-lead ECG parameters [ Time Frame: Duration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00811499 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy as measured by ASAS 20, ASAS 40, ASAS 5/6, BASDAI, BASFI, BASMI, EASMI, SPARCC Enthesitis Index, Nocturnal Back Pain, Total Back Pain, Patient's Global Assessment of Disease Activity, SF-36 Health Questionnaire V2 Acute, and CRP [ Time Frame: Day 1-Day 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics as measured by plasma concentrations of ARRY-371797 and a metabolite [ Time Frame: Days 8, 43 and 85 ] [ Designated as safety issue: No ]
  • Pharmacodynamics as measured by circulating levels of exploratory biomarkers of disease activity, and sacroiliac (SI) and spinal SPARCC MRI scores [ Time Frame: Day 1- Follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: ARRY-371797, p38 inhibitor; oral
    multiple dose, single schedule
  • Drug: Placebo; oral
    matching placebo
  • Drug: Placebo; oral
    multiple dose, single schedule
  • Experimental: ARRY-371797 (Schedule 1)
    Intervention: Drug: ARRY-371797, p38 inhibitor; oral
  • Experimental: ARRY-371797 (Schedule 2)
    Interventions:
    • Drug: ARRY-371797, p38 inhibitor; oral
    • Drug: Placebo; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00811499
ARRAY-797-201
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP