Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

Status:	Completed
Conditions:	Lupus
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	16 - Any
Updated:	4/21/2016
Start Date:	January 2008
End Date:	October 2012

A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

This study is to evaluate the efficacy and safety of atacicept compared to placebo in
preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the
optimal dose of atacicept for treatment of subjects with SLE and gain information on the
effect of atacicept on markers specific to its mechanism of action (MoA) and their
correlation to disease activity/progression. Study medication will be administered through
subcutaneous (under the skin) injections, beginning with twice weekly injections for the
first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a
safety follow-up period of 24 weeks will be conducted.

Inclusion Criteria:

- Male or female 16 years of age or older

- Disease history of at least six months meeting at least 4 out of the 11 American
College of Rheumatology (ACR) criteria for SLE

- Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or
B at screening requiring a change in the dose of corticosteroids

- Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid
(dsDNA) at screening

- Female subjects must be willing to avoid pregnancy by using an adequate method of
contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after
the last dose of study medication

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Active moderate to severe glomerulonephritis (kidney impairment) as defined in the
protocol

- Active central nervous system SLE deemed to be severe/progressive and/or associated
with significant cognitive impairment leading to inability to provide informed
consent and/or comply with the protocol

- Previous treatment with rituximab, abatacept, or belimumab

- History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis

- Other protocol defined exclusion criteria could apply

We found this trial at

sites

Brigham and Women's Hosp

75 Francis street
Boston, Massachusetts 02115

(617) 732-5500