A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Phase 2 Completed 350 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Timeline

Start: 2019-04-18
Primary completion: 2023-10-05
Completion: 2023-10-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs PF-06700841 15 mg; p = 0.8076; Risk Difference (RD) -7.5 (95% CI -24.5 to 9.5); NCT03845517 ↗

registry analysis (superiority test); Placebo vs PF-06700841 30 mg; p = 0.2189; Risk Difference (RD) 5.2 (95% CI -7.9 to 18.3); NCT03845517 ↗

registry analysis (superiority test); Placebo vs PF-06700841 45 mg; p = 0.4010; Risk Difference (RD) 1.7 (95% CI -11.8 to 15.3); NCT03845517 ↗

Publications

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brepocitinib	Small molecule	15 mg	—
Subject	Brepocitinib	Small molecule	30 mg	—
Subject	Brepocitinib	Small molecule	45 mg	—