Phase 3 Lupus Trial, Recruiting
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:
- People whose vaccinations are current according to local health guidelines (a shingles vaccine is recommended but not required).
- People who have a documented diagnosis of Discoid Lupus Erythematosus (DLE) — a form of lupus affecting the skin — and/or Subacute Cutaneous Lupus Erythematosus (SCLE), with or without also having Systemic Lupus Erythematosus (SLE).
- People with an active form of skin lupus called Acute Cutaneous Lupus Erythematosus (ACLE) as their only skin symptom, provided they also have SLE and the skin condition has been present for at least 6 weeks before the screening visit.
- People with SLE who meet a specific set of internationally recognised classification criteria (EULAR/ACR 2019) and also have active skin lupus (DLE, SCLE, and/or ACLE).
- People whose skin lupus — and SLE, if applicable — was diagnosed at least 6 months before the screening visit.
- People whose skin disease activity score (called CLASI-A) is 8 or higher at both the screening visit and Day 1 of the trial (confirm with trial site).
- Additional criteria set by the trial protocol may also apply (confirm with trial site).
Who may not be able to join:
- People whose primary autoimmune condition is something other than skin lupus or SLE, such as systemic sclerosis or rheumatoid arthritis.
- People who have another skin condition unrelated to lupus (such as psoriasis), an 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 throughout the body).
- People whose lupus was caused by a medication (drug-induced lupus).
- People who have active lupus affecting the kidneys and are currently on intensive treatment for it, or who completed that intensive treatment within the past 3 months (note: stable long-term kidney maintenance therapy may still be permitted — confirm with trial site).
- People whose urine or blood tests show certain levels of kidney stress beyond thresholds set by the trial (confirm with trial site for the specific values).
- People who have had any signs, symptoms, or diagnosis related to lupus affecting the brain or nervous system in the past 3 months, or who have a history of seizures that have not been well controlled.
- Additional exclusion criteria set by the trial protocol may also apply (confirm with trial site).
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.
Contact this trial
Principal Investigator: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49 6151 72 5200
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
Where this trial is recruiting
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?
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.