Enpatoran for Lupus
(Elowen-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of a new treatment called enpatoran for people with lupus, specifically those with skin-related symptoms. Participants will take either the medication or a placebo in tablet form over 24 weeks to assess its impact on reducing these skin issues. The trial is suitable for individuals who have experienced lupus-related skin problems for at least six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment for lupus.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, stable maintenance therapy with certain medications like mycophenolate, azathioprine, or an oral calcineurin inhibitor is allowed for participants with lupus nephritis.
Is there any evidence suggesting that enpatoran is likely to be safe for humans?
Research has shown that enpatoran was well-tolerated in past studies. In individuals with lupus, the treatment had a manageable safety profile, with no unexpected safety issues or unknown problems. Reports from earlier studies also noted that enpatoran did not present any new safety concerns, which reassures those considering participation in a clinical trial. This suggests that enpatoran is relatively safe for humans based on the available data.12345
Why do researchers think this study treatment might be promising for lupus?
Enpatoran is unique because it targets the TLR7/8 pathway, which plays a key role in the immune system's overactivity associated with lupus. Unlike standard treatments like corticosteroids or hydroxychloroquine, which can have broad effects on the immune system, Enpatoran offers a more targeted approach, potentially reducing side effects. Researchers are excited because this precision could lead to better management of lupus symptoms with fewer complications, offering new hope for patients seeking more tailored therapies.
What evidence suggests that enpatoran might be an effective treatment for lupus?
Research shows that enpatoran, which participants in this trial may receive, might help people with lupus, especially when it affects the skin. In earlier studies, up to 81.5% of patients with severe skin problems experienced a significant reduction in rash severity after using enpatoran. Another study found that 58.6% of patients responded well to the treatment, compared to 31.7% who took a placebo. Enpatoran targets specific parts of the immune system to lower inflammation. It also proved to be well-tolerated, causing few side effects. These encouraging results suggest that enpatoran could help manage lupus symptoms, particularly those related to the skin.24678
Who Is on the Research Team?
Medical Responsible
Principal Investigator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Are You a Good Fit for This Trial?
This trial is for individuals with active skin symptoms of lupus, with or without systemic disease. They must have a certain severity score, be vaccinated according to local guidelines, and have had lupus for at least 6 months. People with drug-induced lupus, other skin diseases like psoriasis, uncontrolled conditions such as severe asthma or life-threatening lupus complications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Enpatoran or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Enpatoran
Trial Overview
The study tests the efficacy and safety of Enpatoran compared to placebo over 24 weeks in treating cutaneous manifestations of lupus. Participants will visit every four weeks after an initial televisit in week two and take film-coated tablets as part of their treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Lead Sponsor
Danny Bar-Zohar
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Chief Executive Officer
MD
Danny Bar-Zohar
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
Merck KGaA, Darmstadt, Germany
Industry Sponsor
Danny Bar-Zohar
Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
Belén Garijo
Merck KGaA, Darmstadt, Germany
Chief Executive Officer since 2021
MD
Citations
1.
emdserono.com
emdserono.com/us-en/company/news/press-releases/enpatoran-phase-2-data-21-05-2025.html2025-05-21 Positive Phase 2 Data for Enpatoran
The company announced positive data on enpatoran demonstrating reduction in disease activity in patients with cutaneous lupus erythematosus (CLE) and systemic ...
Enpatoran, a first-in-class, selective, orally administered toll ...
Conclusions Enpatoran was well tolerated and demonstrated favourable safety and PK profiles in patients with SLE and CLE. Although preliminary, ...
Enpatoran Phase 2 Data from Cohort B in SLE
In patients with active skin disease (CLASI-A ≥8), BICLA response rates were up to 58.6% while placebo response rates were 31.7%, and up to 60.5 ...
RANDOMIZED, PLACEBO-CONTROLLED PHASE II ...
At baseline, 59.0% of patients were receiving systemic CS, 38.0% immunosuppressants and 76.0% antimalarials; 71% had moderate-to-severe disease ...
Phase II Trial of Lupus Treatment Enpatoran Shows ...
Among those with severe skin involvement, up to 81.5% of those who received enpatoran had at least 50% improvement in rash severity, and 60.5% ...
6.
emdserono.com
emdserono.com/us-en/company/news/press-releases/enpatoran-phase-2-data-cohort-b-11-06-2025.html2025-06-11 Enpatoran Phase 2 Data from Cohort B in SLE
Enpatoran was well-tolerated and exhibited a manageable safety profile consistent with previous studies, with no new safety signals identified.
Enpatoran, a first-in-class, selective, orally administered toll ...
Conclusions: Enpatoran was well tolerated and demonstrated favourable safety and PK profiles in patients with SLE and CLE. Although preliminary, ...
Merck's Enpatoran to Reduce Disease Activity in CLE and ...
In this cohort, enpatoran was well-tolerated, and exhibited a manageable safety profile consistent with previous studies, with no new safety ...
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