A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Phase 2 Completed 260 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).

Timeline

Start: 2017-01-19
Primary completion: 2019-05-28
Completion: 2019-07-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs GDC-0853 (150mg) QD; p = 0.373; Absolute Difference 6.4 (95% CI -8.5 to 21.2); Cochran-Mantel-Haenszel NCT02908100 ↗

paper CONCLUSION: While fenebrutinib had an acceptable safety profile, the primary end point, SRI-4 response, was not met despite evidence of strong pathway inhibition. PMID 34042314 ↗

Publications

Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, McGregor A, Toth B, Rae J, Hwang O, Desai R, Lokku A, Ramamoorthi N, Hackney JA, Miranda P, de Souza VA, Jaller-Raad JJ, Maura Fernandes A, Garcia Salinas R, Chinn LW, Townsend MJ, Morimoto AM, Tuckwell K. Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fenebrutinib	Small molecule	150 mg	Oral
Subject	Fenebrutinib	Small molecule	200 mg	Oral