Status:
COMPLETED
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Lead Sponsor:
Pfizer
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
Eligibility Criteria
Inclusion
- Male and/or female subjects between ≥18 and ≤75 years of age inclusive.
- Diagnosis of moderate to severe active Lupus.
- Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.
Exclusion
- Active renal lupus
- Severe active central nervous system (CNS) lupus
- Have cancer or a history of cancer within 5 years of screening.
- Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
- Active bacterial, viral, fungal, mycobacterial or other infections
- Psychiatric condition including recent or active suicidal ideation or behavior
- Have active fibromyalgia/myofascial/chronic pain.
- Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03845517
Start Date
April 18 2019
End Date
October 5 2023
Last Update
September 5 2024
Active Locations (164)
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1
UAB Department of Medicine Clinical Research Enterprise
Birmingham, Alabama, United States, 35205
2
The Kirklin Clinic
Birmingham, Alabama, United States, 35233
3
UAB Hospital Department of Pharmacy
Birmingham, Alabama, United States, 35249
4
UAB Hospital-Clinical Research Unit (CRU)
Birmingham, Alabama, United States, 35249