A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ARRY-371797, p38 inhibitor; oral
Placebo; oral
Placebo; oral
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility 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.
Sites / Locations
- Cedars-Sinai Medical Center
- Northwestern University
- Westroads Medical Group
- Lynn Health Science Institute
- Oregon Health & Science University
- Low Country Rheumatology
- Arthritis Northwest
- Rheumatology Research Associates Group
- University of Manitoba
- Credit Valley Rheumatology
- Center de Recherche Musculo-Squelettique
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ARRY-371797 (Schedule 1)
ARRY-371797 (Schedule 2)
Placebo
Arm Description
Outcomes
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).
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Secondary Outcome Measures
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Explore potential biomarkers for pharmacodynamics (PD).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811499
Brief Title
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
December 16, 2008 (Actual)
Primary Completion Date
September 29, 2009 (Actual)
Study Completion Date
September 29, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARRY-371797 (Schedule 1)
Arm Type
Experimental
Arm Title
ARRY-371797 (Schedule 2)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARRY-371797, p38 inhibitor; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
multiple dose, single schedule
Primary Outcome Measure Information:
Title
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
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time Frame
12 weeks
Title
Explore potential biomarkers for pharmacodynamics (PD).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Westroads Medical Group
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Low Country Rheumatology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatology Research Associates Group
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
Facility Name
Credit Valley Rheumatology
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Center de Recherche Musculo-Squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z IY2
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Learn more about this trial
A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
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