A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Key facts

Study ID

NCT03845517

Run by

Pfizer

People needed

350

Starts

2019-04-18

Expected to finish

2023-10-05

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States
• UAB Hospital Department of Pharmacy — Birmingham, Alabama, United States
• UAB Hospital-Clinical Research Unit (CRU) — Birmingham, Alabama, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• UAB Department of Medicine Clinical Research Enterprise — Birmingham, Alabama, United States
• St. Joseph Heritage Healthcare — Fullerton, California, United States
• Advanced Medical Research, LLC — La Palma, California, United States
• Arthritis and Osteoporosis Medical Center — La Palma, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Millennium Clinical Trials — Thousand Oaks, California, United States
• Inland Rheumatology and Osteoporosis Medical Group — Upland, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• New England Research Associates — Bridgeport, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Private Practice of Robert W. Levin — Clearwater, Florida, United States
• SIMEDHealth, LLC Attn: Rheumatology — Gainesville, Florida, United States
• SIMEDHealth, LLC — Gainesville, Florida, United States
• Omega Research MetroWest, LLC — Orlando, Florida, United States
• Akumin, Inc — Palm Harbor, Florida, United States
• Akumin Inc — St. Petersburg, Florida, United States
• West Broward Rheumatology Associates, Inc — Tamarac, Florida, United States
• UAB Department of Medicine Clinical Research Enterprise — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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