Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502632-39-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: SAD: RO7507062 | Experimental | Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1. |
|
| Part 2: Dose Escalation with Fractionated Dosing: RO7507062 | Experimental | Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7507062 | Drug | RO7507062 solution for injection will be administered SC as specified in each treatment part (arm). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Adverse Events (DLAEs) | Day 1 through Day 29 | |
| Part 2: Fractionated Dose Cohort: Number of Participants with DLAEs | 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. | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of RO7507062 | Up to approximately 12 months | |
| Time to Maximum Serum Concentration (Tmax) of RO7507062 | Up to approximately 12 months | |
| Maximum Serum Concentration (Cmax) of RO7507062 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica De La Costa | Barranquilla | 080020 | Colombia | |||
| Hospital Pablo Tobon Uribe |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tocilizumab | Drug | 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. |
|
|
| Up to approximately 12 months |
| Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7507062 | Up to approximately 12 months |
| Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of RO7507062 | Up to approximately 12 months |
| Apparent Terminal Half-Life (T1/2) of RO7507062 | Up to approximately 12 months |
| Terminal Rate Constant (λz) of RO7507062 | Up to approximately 12 months |
| Apparent Volume of Distribution (Vz/F) of RO7507062 | Up to approximately 12 months |
| Apparent Total Body Clearance (CL/F) of RO7507062 | Up to approximately 12 months |
| Number of Participants with Anti-Drug Antibodies (ADAs) to RO7507062 | Up to approximately 12 months |
| Medellín |
| 050034 |
| Colombia |
| Oncomedica S.A. | Montería | 230002 | Colombia |
| Hôpital Saint Eloi | Montpellier | 34295 | France |
| Groupe Hospitalier Pitie-Salpetriere | Paris | 75651 | France |
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
| Universitätsklinikum Duesseldorf | Düsseldorf | 40225 | Germany |
| Hospital Umum Sarawak | Kuching | 93586 | Malaysia |
| CREA Hospital Mexico Americano | Guadalajara | Jalisco | 44620 | Mexico |
| Hospital Angeles De Lindavista | Mexico City | Mexico CITY (federal District) | 07760 | Mexico |
| Hospital General De Mexico | Mexico City | Mexico CITY (federal District) | 6726 | Mexico |
| Centre For Human Drug Research | Leiden | 2333 | Netherlands |
| Clínica San Juan Bautista CSJB | Lima | 15431 | Peru |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Późna | 61-848 | Poland |
| Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy | Warsaw | 04-141 | Poland |
| FARMOVS (Pty) Ltd | Bloemfontein | 9301 | South Africa |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| Chang Gung Medical Foundation - Linkou | Taoyuan | 333 | Taiwan |
| Ramathibodi Hospital, Mahidol Uni | Bangkok | 10400 | Thailand |
| UCL Hospital NHS Trust | London | NW1 2PG | United Kingdom |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided