Lupus, Lupus Nephritis, Systemic Lupus Erythematosus
Conditions
Brief summary
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).
Interventions
DRUGMosunetuzumab
Participants will receive SC mosunetuzumab.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Active infection of any kind, excluding fungal infection of the nail beds * Any major episode of infection as defined by the protocol * History of serious recurrent or chronic infection * History of progressive multifocal leukoencephalopathy (PML) * Tuberculosis (TB) infection * History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years * Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening * Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable * High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions * Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex * History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1 * History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years * Receipt of any live or attenuated vaccine in the 28 days prior to or during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who have achieved remission by Week 76 | Up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76 | Up to 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. |
| Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104 | 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. |
| Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104 | 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. |
| Percentage of participants with adverse events (AEs) | Up to 2.5 years | — |
| Longitudinal change in titers of anti-double-stranded (ds) DNA | Up to 2.5 years | — |
| Longitudinal changes in complement C3 and C4 | Up to 2.5 years | — |
| Serum concentration of mosunetuzumab | Up to 2.5 years | — |
| Percentage of participants with anti-drug antibodies (ADAs) | Baseline up to 2.5 years | — |
| CD19+ absolute counts in blood | Up to 2.5 years | — |
| Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue | Baseline to Week 76 | — |
| Change in Subject's Global Assessment of Disease Activity (SGA) | Baseline to Week 76 | — |
Countries
Brazil, Colombia, Italy, Mexico, South Africa
Contacts
CONTACTReference Study ID Number: GA45799 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed