Investigating a new treatment for systemic lupus erythematosus

An Open-label, Multicenter, Dose Escalation, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered RO7507062 in Participants With Systemic Lupus Erythematosus

This study is testing a new treatment for systemic lupus erythematosus to see how safe it is and how well it works for people with the condition.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hoffmann-La Roche (industry)
• Drugs / interventions: blinatumomab, obinutuzumab, rituximab, ocrelizumab, ofatumumab, adalimumab, golimumab, infliximab, belimumab, ustekinumab, anifrolumab, secukinumab, baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, fenebrutinib, methotrexate, cyclophosphamide, prednisone, Tocilizumab
• Locations: 24 sites (Barranquilla and 23 other locations)
• Trial ID: NCT05835986 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7507062 in individuals diagnosed with systemic lupus erythematosus (SLE). It consists of two parts: the first part involves a single ascending dose-finding approach, while the second part focuses on dose escalation with fractionated dosing. Tocilizumab may also be administered if necessary to manage cytokine release syndrome during the study. Participants will be closely monitored for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with systemic lupus erythematosus who meet specific clinical criteria and have active disease.

Not a fit: Patients with mild or inactive systemic lupus erythematosus may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise in targeting systemic lupus erythematosus with novel therapies, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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).

Where this trial is running

Barranquilla and 23 other locations

• Clinica De La Costa — Barranquilla, Colombia (RECRUITING)
• Hospital Pablo Tobon Uribe — Medellín, Colombia (RECRUITING)
• Oncomedica S.A. — Montería, Colombia (RECRUITING)
• Hôpital Saint Eloi — Montpellier, France (RECRUITING)
• Groupe Hospitalier Pitie-Salpetriere — Paris, France (RECRUITING)
• Charité Research Organisation GmbH — Berlin, Germany (RECRUITING)
• Universitätsklinikum Duesseldorf — Düsseldorf, Germany (RECRUITING)
• Hospital Umum Sarawak — Kuching, Malaysia (RECRUITING)
• CREA Hospital Mexico Americano — Guadalajara, Jalisco, Mexico (RECRUITING)
• Hospital Angeles De Lindavista — Mexico City, Mexico CITY (federal District), Mexico (RECRUITING)
• Hospital General De Mexico — Mexico City, Mexico CITY (federal District), Mexico (RECRUITING)
• Centre For Human Drug Research — Leiden, Netherlands (COMPLETED)
• Clínica San Juan Bautista CSJB — Lima, Peru (RECRUITING)
• Uniwersytecki Szpital Kliniczny w Poznaniu — Późna, Poland (RECRUITING)
• MICS Centrum Medyczne Damiana, Walbrzyska — Warsaw, Poland (WITHDRAWN)
• Wojskowy Instytut Medyczny- Panstwowy Instytut Badawczy — Warsaw, Poland (RECRUITING)
• FARMOVS (Pty) Ltd — Bloemfontein, South Africa (RECRUITING)
• Hospital Universitario Reina Sofia — Córdoba, Spain (RECRUITING)
• Hospital General Universitario Gregorio Marañon — Madrid, Spain (RECRUITING)
• Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
• Chung Shan Medical University Hospital — Taichung, Taiwan (RECRUITING)
• Chang Gung Medical Foundation - Linkou — Taoyuan, Taiwan (RECRUITING)
• Ramathibodi Hospital, Mahidol Uni — Bangkok, Thailand (RECRUITING)
• UCL Hospital NHS Trust — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: BP44315 https://forpatients.roche.com/

Conditions: Systemic Lupus Erythematosus