Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus (BUTTERFLY)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: PF-04236921

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405196

2011-000420-15 (EudraCT Number)

B0151006

BUTTERFLY (Other Identifier)

Details and patient eligibility

About

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Enrollment: 183 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between ages of 18 and 75 years old at time of signing consent.
• Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
• Have a unequivocally positive anti-nuclear antibody (ANA) test result.
• Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion criteria

• Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
• Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 4 patient groups

10 mg of PF-04236921

Other group

Treatment:

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

50 mg of PF-04236921

Other group

Treatment:

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

200 mg of PF-04236921

Other group

Treatment:

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

Placebo

Other group

Treatment:

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921

Biological: PF-04236921