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

• Status: Recruiting
• Trial end date: 2023-08-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: PF-06700841

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.