A Phase 1 interventional study of RO7507062 and Tocilizumab in Systemic Lupus Erythematosus, sponsored by Hoffmann-La Roche. Active, not recruiting at 18 sites in 13 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.
Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1.
Drug: RO7507062 · Drug: Tocilizumab
Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days.
Drug: RO7507062 · Drug: Tocilizumab
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
When applicable, tocilizumab solution for infusion will be administered intravenously at 8 milligram per kilogram (mg/kg) for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.
Also known as: Actemra, RoActemra
Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs)
Time frame: Day 1 through Day 29
Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs
Time frame: Day 1 through to the end of the 28-day safety evaluation period
Number of Participants with Adverse Events (AEs)
Adverse events will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and CRS, will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
Time frame: Up to approximately 12 months
Serum Concentration of RO7507062
Time frame: Up to approximately 12 months
Time to Maximum Serum Concentration (Tmax) of RO7507062
Time frame: Up to approximately 12 months
Maximum Serum Concentration (Cmax) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062
Time frame: Up to approximately 12 months
Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of RO7507062
Time frame: Up to approximately 12 months
Apparent Terminal Half-Life (T1/2) of RO7507062
Time frame: Up to approximately 12 months
Terminal Rate Constant (λz) of RO7507062
Time frame: Up to approximately 12 months
Apparent Volume of Distribution (Vz/F) of RO7507062
Time frame: Up to approximately 12 months
Apparent Total Body Clearance (CL/F) of RO7507062
Time frame: Up to approximately 12 months
Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062
Time frame: Up to approximately 12 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Hoffmann-La Roche