A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
NCT ID: NCT05835986
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2023-12-18
2027-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
NCT05155345
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
NCT05203692
Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
NCT07010835
Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
NCT05203419
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus
NCT02535689
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part 1: SAD: RO7507062
Participants will receive RO7507062 at an assigned dose as subcutaneous (SC) injection on Day 1.
RO7507062
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
Tocilizumab
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.
Part 2: Dose Escalation with Fractionated Dosing: RO7507062
Participants will receive RO7507062 as SC injection at the dose determined in Part 1, on Day 1 and as escalated doses on subsequent days.
RO7507062
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
Tocilizumab
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RO7507062
RO7507062 solution for injection will be administered SC as specified in each treatment part (arm).
Tocilizumab
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Receipt of any anti- cluster of differentiation (CD)19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening.
* Receipt of Inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2 including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, and fenebrutinib,or any investigational agent within 30 days prior to screening or during screening.
* Receipt of Cyclophosphamide or a biologic therapy such as, but not limited to, adalimumab, etanercept, golimumab, infliximab, belimumab,ustekinumab, anifrolumab, secukinumab, or atacicept, within 4 weeks prior to enrollment.
* Active tuberculosis or history of recurring or severe active tuberculosis, or a positive Interferon Gamma Release Assay (IGRA). Latent tuberculosis which has been treated prior to baseline is not exclusive.
* Receipt of an investigational therapy (except severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\] vaccines) within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study.
* Immunoglobulin (IgG) level of \<6 gram per liter (g/L).
* Estimated glomerular filtration rate (eGFR) \<45 milliliter per minute (mL/min)/1.73-meter square (m\^2).
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinica De La Costa
Barranquilla, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Oncomedica S.A.
Montería, , Colombia
Hôpital Saint Eloi
Montpellier, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Charité Research Organisation GmbH
Berlin, , Germany
Universitätsklinikum Duesseldorf
Düsseldorf, , Germany
Hospital Umum Sarawak
Kuching, , Malaysia
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico
Hospital Angeles De Lindavista
Mexico City, Mexico CITY (federal District), Mexico
Hospital General De Mexico
Mexico City, Mexico CITY (federal District), Mexico
Centre For Human Drug Research
Leiden, , Netherlands
Clínica San Juan Bautista CSJB
Lima, , Peru
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, , Poland
MICS Centrum Medyczne Damiana, Walbrzyska
Warsaw, , Poland
Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy
Warsaw, , Poland
FARMOVS (Pty) Ltd
Bloemfontein, , South Africa
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Chung Shan Medical University Hospital
Taichung, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Ramathibodi Hospital, Mahidol Uni
Bangkok, , Thailand
UCL Hospital NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-502632-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
BP44315
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.