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

  • STATUS
    Recruiting
  • End date
    Aug 23, 2023
  • participants needed
    448
  • sponsor
    Pfizer
Updated on 19 September 2021
corticosteroids
methotrexate
azathioprine
leflunomide
lupus
mycophenolate
antimalarials

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.

Details
Condition Autoimmune disease, CONNECTIVE TISSUE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS, Dermatomyositis (Connective Tissue Disease), Connective Tissue Diseases
Treatment Placebo, PF-06700841 15 mg, PF-06700841 30 mg, PF-06700841 45 mg
Clinical Study IdentifierNCT03845517
SponsorPfizer
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

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
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