Enpatoran for Lupus

Recruiting at 3 trial locations

Overseen By Communication Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Disqualifiers: Autoimmune rheumatic disease, Psoriasis, Uncontrolled disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called enpatoran for people with lupus, specifically those with skin symptoms. The goal is to determine if enpatoran reduces these skin problems compared to a placebo (a pill with no active drug). People with lupus skin issues, such as discoid or subacute cutaneous lupus, who have experienced these symptoms for at least six months, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Is there any evidence suggesting that enpatoran is likely to be safe for humans?

Research has shown that enpatoran is generally well tolerated. Various studies have found no higher risk of serious side effects compared to a placebo, which is similar to a sugar pill. This indicates that enpatoran does not cause more severe health issues than a sugar pill.

In past trials, enpatoran demonstrated a manageable safety profile, meaning any side effects were neither severe nor unexpected. Recent studies have not identified any new safety concerns, suggesting that the treatment remains consistently safe across different trials.

Overall, the available data suggests that enpatoran is safe for treating lupus. However, discussing any concerns or questions with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Enpatoran is unique because it targets the body's immune system differently than current lupus treatments like corticosteroids and immunosuppressants. Most current treatments aim to broadly suppress the immune system, but Enpatoran specifically inhibits the TLR7 and TLR8 pathways, which are involved in the overactive immune response seen in lupus. Researchers are excited about Enpatoran because this targeted approach might offer better control of the disease with potentially fewer side effects, providing a more precise option for patients with lupus.

What evidence suggests that enpatoran might be an effective treatment for lupus?

Research has shown that enpatoran, which participants in this trial may receive, may help treat lupus, particularly for those with skin problems. In previous studies, up to 81.5% of patients with severe skin issues saw their rashes improve by at least half. The drug was generally safe, with most people not experiencing serious side effects. Patients also experienced less overall disease activity, including those with systemic lupus, indicating it helped manage symptoms throughout the body. Overall, these findings suggest that enpatoran could be an effective treatment for lupus with skin symptoms. ^{2 3 4 5 6}

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?

Inclusion Criteria

I have SLE and currently have active DLE, SCLE, or ACLE skin symptoms.

I have had my disease for at least 6 months.

Participants with CLASI-A score >= 8 at Screening and Day 1 visits

Exclusion Criteria

Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation

Participants with drug-induced lupus (SLE or CLE)

I have an autoimmune rheumatic disease, but not CLE or SLE.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Enpatoran or placebo for 24 weeks to evaluate efficacy and safety in treating cutaneous manifestations of lupus erythematosus

24 weeks

Visits every 4 weeks, with a televisit at Week 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enpatoran

How Is the Trial Designed?

Group I: Enpatoran Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Lead Sponsor

Trials

60

Recruited

7,900+

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

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials

449

Recruited

122,000+

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.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(26)00463-0/fulltext

Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to- ...

In a Phase 1b trial in patients with cutaneous lupus erythematosus (CLE), afimetoran was well tolerated and associated with reduced expression ...

2.

emdserono.com

emdserono.com/us-en/company/news/press-releases/enpatoran-phase-2-data-cohort-b-11-06-2025.html

2025-06-11 Enpatoran Phase 2 Data from Cohort B in SLE

Company presents phase 2 data of enpatoran in systemic lupus erythematosus, highlighting improved efficacy in patients with active skin manifestations.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2665991325003376

Efficacy and safety of enpatoran, a Toll-like receptor 7/8 ...

Overall, enpatoran was well tolerated, with no increased risk of serious adverse events or cutaneous adverse events compared with placebo.

4.

jrheum.org

jrheum.org/content/52/Suppl_1/11.1

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12557744/

Enpatoran, a first-in-class, selective, orally administered toll ...

Enpatoran was well tolerated and demonstrated favourable safety and PK profiles in patients with SLE and CLE. Although preliminary, the SLE ...

6.

clinicaltrialsarena.com

clinicaltrialsarena.com/analyst-comment/new-phase-ii-safety-data-enpatoran-move-phase-iii/

New Phase II safety data supports enpatoran's move to ...

At SLEuro 2026, Merck KGaA presented new safety and tolerability data for enpatoran in development for CLE and SLE.