NCT05155345

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

A Phase Ib, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus (SLE).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Participants will receive subcutaneous (SC) mosunetuzumab on either Day 1 or on Days 1 and 8.
DRUG	Tocilizumab	Participants will receive intravenous (IV) tocilizumab as needed to manage adverse reactions.

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2021-12-13
• Last updated: 2025-04-29

Locations

3 sites across 3 countries: United States, Moldova, Poland

Regulatory

• FDA-regulated drug study