Phase 2
N=306
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT01972568 ↗Enrolled (actual)
306
Serious AEs
8.8%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline — 57.8; 53.8; 44.0 percentage of subjects — p=0.1208
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atacicept 75 milligram (mg) (Drug); Atacicept 150 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline |
57.8; 53.8; 44.0 | 0.1208 |
| PRIMARY Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline |
55.9; 55.8; 41.0 | 0.0202 sig |
| SECONDARY Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity |
17.9; 11.3; 18.9 | — |
| SECONDARY Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 |
57.8; 53.8; 46.0; 39.2; 44.2; 46.0 | — |
| SECONDARY Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 |
-2.64; -1.87; -1.89 | — |
| SECONDARY Time From Randomization to First SRI Response During Treatment Period |
12.4; 16.1; 16.1 | — |
| SECONDARY Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24 |
53.4; 49.0; 45.2 | — |
| SECONDARY Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
81.4; 80.8; 72.0; 8.8; 5.8; 12.0 | — |
| SECONDARY Change From Week 0 (Day 1) in SF-36 Components at Week 24 |
4.7; 3.4; 3.5; 1.9; 1.8; 0.7 | — |
Summary
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
Eligibility Criteria
Inclusion Criteria
- Eligible male and female subjects, aged 18 years or older
- Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit
- At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)
- Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Subjects have demyelinating disorder
- Severe central nervous system SLE
- Use of cyclophosphamide within 3 months of the screening visit
- Urine protein: creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT01972568). 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.