Phase 3 Lupus Trial, Recruiting NCT07355218 Sponsor: EMD Serono Research & Development Institute, Inc. Condition: Lupus
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Phase 3 Lupus Trial, Recruiting

NCT07355218
Recruiting Phase 3

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:

  • Your vaccinations are up to date based on the recommendations where you live (a specific shingles vaccine is encouraged but not required).
  • You have been diagnosed with Discoid Lupus Erythematosus (a type of lupus that affects the skin, causing scarring rashes) and/or Subacute Cutaneous Lupus Erythematosus (another skin form of lupus), with or without also having Systemic Lupus Erythematosus (lupus that can affect the whole body).
  • You have a certain active form of skin lupus called Acute Cutaneous Lupus Erythematosus as your only skin symptom, alongside Systemic Lupus Erythematosus, and it has been present for at least 6 weeks before your first study visit.
  • If you have Systemic Lupus Erythematosus, your diagnosis meets specific internationally recognised medical classification standards (confirm with trial site).
  • If you have Systemic Lupus Erythematosus, you have had your skin or lupus condition for at least 6 months since diagnosis.
  • If you have Systemic Lupus Erythematosus, your skin lupus is currently active enough to reach a certain score on a standard medical measurement scale used by doctors (confirm with trial site).
  • Additional eligibility requirements set by the trial may also apply.

Who may not be able to join:

  • You have been primarily diagnosed with a different autoimmune or rheumatic disease (such as rheumatoid arthritis or systemic sclerosis) that is not lupus of the skin or Systemic Lupus Erythematosus.
  • You have another skin condition unrelated to lupus (such as psoriasis), another serious uncontrolled illness (such as severe asthma or certain lung conditions), or a life-threatening form of lupus (such as active inflammation of the blood vessels), which the study doctors consider too risky for participation.
  • Your lupus was caused by a medication you have taken (known as drug-induced lupus).
  • You have active kidney inflammation caused by lupus and are currently receiving or have recently finished (within the last 3 months) an intensive treatment course for it (note: stable, ongoing lower-level kidney treatment may still be allowed — confirm with trial site).
  • Your kidney test results show certain levels of protein in your urine or reduced kidney function that fall outside the limits set by the trial (confirm with trial site for specific values).
  • You have had any active signs, symptoms, or a diagnosis of lupus affecting your brain or nervous system in the past 3 months, or you have a history of seizures that are not well controlled.
  • Additional exclusion requirements set by the trial may also apply.

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 28 July 2026
Phase 3: approximately ~65% 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: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: 888-275-7376

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 3
Sponsor
EMD Serono Research & Development Institute, Inc.
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
25 May 2029

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline

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: 28 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