Phase 3
Completed N=461
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT00624338 ↗
Enrolled (actual)
461
Serious AEs
17.6%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B — 57.32; 36.11; 53.25 percentage of participants — p=0.518
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B |
57.32; 36.11; 53.25 | 0.518 |
| SECONDARY Time to First New Flare as Defined by BILAG Score A or B |
143; 310; 142 | 0.929 |
| SECONDARY Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks |
40.13; 28.47; 35.06 | 0.412 |
| SECONDARY Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares |
52.3; 60.5; 52.9; 39.8; 28.9; 38.2 | — |
| SECONDARY Mean Cumulative Corticosteroid Dose |
2456.79; 2018.87; 2624.02 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00624338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.