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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: PF-06700841 45 mg; Drug: PF-06700841 15 mg; Drug: PF-06700841 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03845517

B7931028

2018-004175-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 350 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

PF-06700841 15 mg

Experimental group

Description:

PF-06700841 15 mg

Treatment:

Drug: PF-06700841 15 mg

PF-06700841 30 mg

Experimental group

Description:

PF-06700841 30 mg

Treatment:

Drug: PF-06700841 30 mg

PF-06700841 45 mg

Experimental group

Description:

PF-06700841 45 mg

Treatment:

Drug: PF-06700841 45 mg