2026-527221-35-00RecruitingPhase 1/2
A Study of RO7871996 in Participants with Systemic Lupus Erythematosus
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 31 Aug 2026
- Start date
- 28 Oct 2026
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Lupus (SLE)
- EU CT number
- 2026-527221-35-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 7
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe active systemic autoimmune disease other than SLE
- High risk for clinically significant bleeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Recruiting |
| Parc Tauli Hospital Universitari | Sabadell | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.