A Study of RO7871996 in Participants with Systemic Lupus Erythematosus
Key facts
- Where
- Barcelona, Madrid, Pamplona és Sabadell, SpanyolországSee the 4 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Clínica Universidad de navarraPamplona, SpanyolországTaking people
- Parc Tauli Hospital UniversitariSabadell, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2026-527221-35-00
- Record updated
- 2026. október 23.
- Original description
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) To evaluate the safety and tolerability of single and multiple subcutaneous (SC) injections of RO7871996 in participants with active SLE Phase 2: To assess the clinical efficacy of RO7871996 and comparator treatment.Read full original descriptionShow less
A Multicenter, Dose-Escalation and Dose-Finding, First-In-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Subcutaneously Administered RO7871996 in Participants with Active Systemic Lupus Erythematosus
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) To evaluate the safety and tolerability of single and multiple subcutaneous (SC) injections of RO7871996 in participants with active SLE Phase 2: To assess the clinical efficacy of RO7871996 and comparator treatment.
Inclusion: Diagnosed with SLE at least 24 weeks prior to informed consent, as assessed using the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for SLE; Any of the following SLE autoantibodies within 5 years prior to the first screening visit or during screening: - positive antinuclear antibody (ANA) (titer ≥ 1:160), OR - anti-double-stranded DNA (anti-dsDNA) antibodies above the upper limit of normal (ULN), OR - anti-Smith antibody (anti-Sm) above ULN; Currently receiving one or more of the following classes of therapy for the treatment of SLE and fulfils the associated requirements: - Oral glucocorticoids ≤ 20 mg/day, prednisone or equivalent, and stable for at least 7 days prior to Day 1 - Conventional immunosuppressants (i.e., azathioprine, sulfasalazine, mycophenolate mofetil (MMF), mycophenolic acid, calcineurin inhibitor and methotrexate [oral, SC, or intramuscular routes]), stable for at least 6 weeks prior to Day 1 and expected to remain stable during the study.
Exclusion: Severe active systemic autoimmune disease other than SLE; High risk for clinically significant bleeding.