A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

NCT05835986 | Recruiting Phase 1

• 2 other identifiers: BP443152022-502632-39-00
• Study Type: interventional
• Target: 70
• Locations: 13 countries
• Sites: 24

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• 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

  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

Study Arms (2)

Part 1: SAD: RO7507062

EXPERIMENTAL

Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1.

Drug: RO7507062; Drug: Tocilizumab

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.

Drug: RO7507062; Drug: Tocilizumab

Interventions

RO7507062 DRUG

RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).

Part 1: SAD: RO7507062; Part 2: Dose Escalation with Fractionated Dosing: RO7507062

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.

Also known as: Actemra, RoActemra

Part 1: SAD: RO7507062; Part 2: Dose Escalation with Fractionated Dosing: RO7507062

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria at least 24 weeks prior to Screening and should have been treated for SLE according to standard clinical practice.
• Presence of anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP) or anti-Sjögren's syndrome antigen A (SS-A) above the upper limit of normal (ULN); or, positive anti-nuclear antibody (ANA; ≥ 1:160).
• Active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score of ≥4 with at least 1 positive clinical item.
• For participants receiving oral corticosteroids (OCS), treatment with ≤ 20 milligram per day (mg/day) prednisone or equivalent, during Screening, at a dose that has been stable for at least 7 days prior to Day 1.
• For participants receiving conventional immunosuppressants (e.g., azathioprine, sulfasalazine, mycophenolate mofetil \[≤ 3.0 grams per day\], mycophenolic acid \[≤ 3 grams per day\], methotrexate \[oral, SC, or intramuscular routes\]), and calcineurin inhibitors \[oral\]), treatment should be at a stable dose for at least 6 weeks prior to Screening and during Screening and expected to remain stable during the study.

You may not qualify if:

• Active or unstable lupus-associated neuropsychiatric disease.
• Catastrophic or severe antiphospholipid syndrome within 12 months prior to Screening or during Screening.
• Presence of severe lupus-associated renal disease that is likely to require treatment with cyclophosphamide, B-cell-depleting therapies, other biologic or targeted therapies.
• Organ-threatening SLE manifestations (e.g., active myocarditis) considered to be severe by the Investigator.
• Severe active systemic autoimmune disease other than SLE.
• Active infection of any kind, excluding fungal infection of the nail beds.
• History of serious recurrent or chronic infection, especially; recurring, chronic infections specifically related to respiratory issues.
• Moderate or severe chronic obstructive pulmonary disease (COPD).
• History of progressive multifocal leukoencephalopathy (PML).
• History of macrophage-activation syndrome and/or hemophagocytic lymphohistiocytosis.
• History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the 5 years prior to the Screening visit (with the exception of basal cell carcinoma, non melanoma skin cancer, and cervical cancer in situ, if these have been adequately treated and are considered cured).
• Intolerance or contraindication to study therapies including history of severe allergic or anaphylactic reactions to monoclonal antibodies (mAbs) or known hypersensitivity to any component of the RO7507062 injection.
• History of infection with hepatitis B virus (HBV), or positive serology indicative of current or past HBV infection.
• Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \[RNA\]).
• Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (24)

Clinica De La Costa

Barranquilla, 080020, Colombia

RECRUITING

Hospital Pablo Tobon Uribe

Medellín, 050034, Colombia

RECRUITING

Oncomedica S.A.

Montería, 230002, Colombia

RECRUITING

Hôpital Saint Eloi

Montpellier, 34295, France

RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, 75651, France

RECRUITING

Charité Research Organisation GmbH

Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Hospital Umum Sarawak

Kuching, 93586, Malaysia

RECRUITING

CREA Hospital Mexico Americano

Guadalajara, Jalisco, 44620, Mexico

RECRUITING

Hospital Angeles De Lindavista

Mexico City, Mexico CITY (federal District), 07760, Mexico

RECRUITING

Hospital General De Mexico

Mexico City, Mexico CITY (federal District), 6726, Mexico

RECRUITING

Centre For Human Drug Research

Leiden, 2333, Netherlands

COMPLETED

Clínica San Juan Bautista CSJB

Lima, 15431, Peru

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, 61-848, Poland

RECRUITING

MICS Centrum Medyczne Damiana, Walbrzyska

Warsaw, 02-739, Poland

WITHDRAWN

Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy

Warsaw, 04-141, Poland

RECRUITING

FARMOVS (Pty) Ltd

Bloemfontein, 9301, South Africa

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

Chang Gung Medical Foundation - Linkou

Taoyuan, 333, Taiwan

RECRUITING

Ramathibodi Hospital, Mahidol Uni

Bangkok, 10400, Thailand

RECRUITING

UCL Hospital NHS Trust

London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

BP44315 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 28, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); ZA (1); TW (2); ME (3); CO (3); MY (1); PL (3); TH (1); FR (2); NL (1); GB (1); DE (2); PE (1)