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

NCT03845517

CompletedPhase 2

Sponsor: Pfizer

Conditions: Systemic Lupus Erythematosus

Interventions: Placebo, PF-06700841 15 mg, PF-06700841 30 mg, PF-06700841 45 mg

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.
Locations (164)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Fullerton, California, United States
  • La Palma, California, United States
  • La Palma, California, United States
  • Palm Desert, California, United States
  • San Leandro, California, United States
  • Thousand Oaks, California, United States
  • Upland, California, United States
  • Upland, California, United States
  • Bridgeport, Connecticut, United States
  • Bridgeport, Connecticut, United States
  • Stamford, Connecticut, United States
  • Clearwater, Florida, United States
  • Clearwater, Florida, United States
  • Gainesville, Florida, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Palm Harbor, Florida, United States
  • St. Petersburg, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Decatur, Georgia, United States
  • + 134 more on CT.gov