A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
Summary
The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
Timeline
- Start
- 2016-02-16
- Primary completion
- 2018-07-17
- Completion
- 2018-07-17
Outcome
Missed primary endpoint
paper This endpoint did not reach statistical significance: 21 of 50 obexelimab-treated patients (42.0%) versus 12 of 42 patients (28.6%) treated with a placebo (P = 0.183). PMID 37459248 ↗
paper CONCLUSION: Although the primary endpoint was not reached, secondary analysis showed time to LOI was significantly increased in obexelimab-treated patients PMID 37459248 ↗
release “Positive trend in primary endpoint; proportion of efficacy-evaluable patients who did not experience loss of improvement (LOI) by Day 225 did not meet statistical significance” xencor.com ↗
Publications
- Background Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606.
- Background Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Merrill JT, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh SZ, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James JA, Zack DJ. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Arthritis Rheumatol. 2023 Dec;75(12):2185-2194. doi: 10.1002/art.42652.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obexelimab | Monoclonal antibody | 5 mg/kg | Intravenous |