A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche
About this trial
This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria at screening
Disqualifiers
Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study
Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration
Alcohol or substance abuse within the 12 months prior to screening
Trial design
Design model
Single group
Treatments tested in this trial
Mosunetuzumab
DrugParticipants will receive SC mosunetuzumab.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: MosunetuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who have achieved remission by Week 76
Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted.
Time frame
Up to Week 76Secondary outcomes
1
Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76
DORIS remission is defined as achievement of all of the following for at least 6 months: Clinical systemic lupus erythematosus disease activity index (cSLEDAI) = 0 after completion of mosunetuzumab treatment; stable dosing of SLE therapies for at least 6 months; Physician Global Assessment (PGA) of \< 0.5, and; prednisone (or equivalent) dose ≤5 mg/day.
Time frame
Up to Week 762
Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104
CRR is defined as all of the following: Urinary protein-to-creatinine ratio (UPCR) \< 0.5 g/g, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml/min per 1.73 m\^2 of body-surface area.
Time frame
Weeks 24, 52, 76, and 1043
Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104
PRR is defined as all of the following: ≥ 50% reduction in UPCR from baseline; UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was ≥ 3 g/g), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation.
Time frame
Weeks 24, 52, 76, and 1044
Percentage of participants with adverse events (AEs)
Time frame
Up to 2.5 yearsSponsors and contacts
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Source ClinicalTrials.gov