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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT05155345
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 11, 2022
Status verified
Apr 2025
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-fractionated/Dose-finding
    Participants will receive a single dose of mosunetuzumab.
  • Experimental: Fractionated/Dose-escalation
    Participants will receive a fractionated (divided) dose of mosunetuzumab on Days 1 and 8.

Primary Outcome Measure

Percentage of participants with adverse events (AEs) [ Time Frame: For a minimum of 12 months after mosunetuzumab dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-

Find similar trials in Anniston, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Pinnacle Research Group· Anniston, AL

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