Phase 2 Lupus Trial, Recruiting NCT07598396 Sponsor: Hoffmann-La Roche Condition: Lupus
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Phase 2 Lupus Trial, Recruiting

NCT07598396
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease) for at least 6 months, confirmed using standard medical guidelines

Who may not be able to join:

  • You are pregnant, breastfeeding, planning to become pregnant during the study, or unwilling to use contraception as required by the trial
  • You have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the drug)
  • You had major surgery requiring a hospital stay in the 4 weeks before the study starts, or you have planned surgery requiring hospitalisation in the 12 weeks after receiving the study drug
  • You have had problems with alcohol or drug misuse in the past 12 months
  • You currently have any kind of active infection (except a fungal infection affecting only your nails)
  • You have had a major infection, as defined by the trial's guidelines (confirm with trial site)
  • You have a history of serious, repeated, or long-lasting infections
  • You have a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
  • You have or have had a tuberculosis (TB) infection
  • You have been diagnosed with cancer — including solid tumours, blood cancers, or early-stage cancer — within the past 5 years
  • You have had a serious overlap of SLE with certain other autoimmune conditions (mixed connective tissue disease or systemic sclerosis) in the past 12 months
  • You have had a severe form of antiphospholipid syndrome (a blood-clotting disorder) in the past 12 months, unless it has been well controlled with blood-thinning medication for at least 2 months
  • You are at high risk of serious bleeding, or you require certain specific medical treatments such as plasma exchange or intravenous immunoglobulin
  • You have active, severe, or unstable lupus affecting your brain or mental health, or the trial doctor believes you are likely to need treatments not allowed in this trial
  • You have taken steroid tablets, injections, or infusions for more than 14 days total in the past year for a condition other than SLE
  • You have received a specific type of immune therapy called a T cell-engaging bispecific antibody or CAR-T cell therapy in the past 2 years
  • You have received a live or weakened live vaccine in the 28 days before or during the screening period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728 (U.S. Only)

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
25 May 2026
Est. completion
28 February 2028

Where this trial is recruiting

🇧🇷 Brazil 🇨🇴 Colombia 🇮🇹 Italy 🇿🇦 South Africa

Primary endpoints

Proportion of participants who have achieved remission by Week 76

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov