Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT05162586) looked at a medicine called enpatoran in people with lupus — a condition where the immune system can attack the body's own tissues. The trial was split into two groups: Cohort A (people with skin-affecting lupus) and Cohort B (people with a broader, more systemic form of lupus). In total, 456 people took part across all groups. Cohort A compared a placebo (a dummy treatment with no active ingredient) against three different doses of enpatoran — 25 mg, 50 mg, and 100 mg — over 16 weeks. Cohort B did the same across 24 weeks, but was structured across two parts. The reported data shows that for Cohort A, the main thing being measured was change in a skin disease score called CLASI-A (which runs from 0 to 70, where higher numbers mean more severe skin disease). At week 16, the placebo group's average score dropped by 5.0 points, while the three enpatoran groups dropped by 9.0, 10.2, and 9.7 points respectively. For Cohort B, the main measurement was how many participants met a specific set of criteria for overall disease improvement (called a BICLA response) at week 24. The reported data shows that out of those assessed, 37 participants in the placebo group met that response, compared with 41 in the 25 mg group, 36 in the 50 mg group, and 56 in the 100 mg group. The reported data also shows figures for a number of secondary measurements. The number of participants who experienced treatment-emergent adverse events (that is, any unwanted medical occurrence during the treatment period) ranged from 12 out of 26 in Cohort A's placebo group up to 70 out of 114 in Cohort B's 100 mg enpatoran group. Regarding abnormal laboratory test results at a severe level, zero participants across all groups were reported to have these. Similarly, zero participants across all groups were reported to have clinically important changes in a heart-rhythm measurement (QTcF). A skin severity rating by doctors (CLA-IGA, on a 0–4 scale) was also measured; for Cohort A at week 16, the placebo group's average score dropped by 0.9 points, while the enpatoran groups dropped by 1.7, 1.5, and 1.8 points respectively; the Cohort B figures for this measure at week 24 were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42107375) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Lupus Trial, Completed
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 active skin lupus (a type called SCLE or DLE) with a skin disease activity score of 8 or higher on a specific measurement scale called CLASI-A.
- You have active lupus (SLE) with a skin activity score of 8 or higher, along with other measures of lupus activity reaching certain levels on standard lupus scoring tools (confirm with trial site for exact score requirements).
- You are already taking at least one standard lupus treatment at a stable dose, such as an immune-suppressing or immune-modulating medication, steroid tablets, or steroid creams/ointments applied to the skin.
- There may be additional requirements set by the trial that are not listed here (confirm with trial site).
Who may not be able to join:
- You have an autoimmune or joint/inflammatory disease other than lupus (SLE or skin lupus).
- You have a skin condition that is not related to lupus.
- You have a serious medical condition that is not well controlled, including significant heart problems, active kidney inflammation caused by lupus, or an active neurological (brain or nerve) disorder.
- You currently have an active or serious infection caused by a virus, bacteria, or fungus.
- You have a history of uncontrolled seizures or other neurological (brain or nerve) conditions.
- You have HIV, hepatitis C, or hepatitis B, or have tested positive for any of these.
- You have a history of cancer of any kind.
- There may be additional reasons set by the trial that could prevent participation (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, EMD Serono Research & Development Institute, Inc.
Australian sites
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Cohort A: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-A (CLASI-A) Total Score at Week 16; Cohort B: Number of Participants With British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) Response at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.