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Taking people in SpainPhase 1/2

RO7871996 Injections for Adults With Active Systemic Lupus Erythematosus

Tests the safety of RO7871996 injections in adults with active lupus.

Key facts

Who runs it
F. Hoffmann-La Roche AG
Where
Barcelona, Madrid, Pamplona, and Sabadell, SpainSee the 4 sites
Registry title
A Study of RO7871996 in Participants with Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 1/2
People taking part
7 people, planned
Started
28 Oct 2026
Expected to end
1 Sept 2030
Type of study
Interventional
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active systemic lupus erythematosus (SLE) who are already on SLE treatment. It tests RO7871996, given as injections under the skin.

Age
18 years or older
Sex
All sexes can join
Disease stage
Active SLE, diagnosed at least 24 weeks before consent using the 2019 EULAR/ACR criteria
Earlier treatment
Must currently take SLE treatment: oral glucocorticoids of 20 mg/day or less, stable for at least 7 days, or conventional immunosuppressants, stable for at least 6 weeks
Biomarker or test result
One of these SLE antibodies: positive ANA (titer ≥ 1:160), anti-dsDNA above the upper limit of normal, or anti-Sm above the upper limit of normal

Main reasons for not taking part

  • Severe active autoimmune disease other than SLE
  • High risk of clinically significant bleeding

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Severe active systemic autoimmune disease other than SLE
  • High risk for clinically significant bleeding

Where in Spain

  • Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
  • Hospital Universitario La PazMadrid, SpainTaking people
  • Clínica Universidad de navarraPamplona, SpainTaking people
  • Parc Tauli Hospital UniversitariSabadell, SpainTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
RO7871996 Injections for Adults With Active Systemic Lupus ErythematosusGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 October 2026