A Study of Enpatoran in Cutaneous Manifestations of Lupus With or Without Systemic Disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Healthcare KGaA

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-06-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Healthcare KGaA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate the efficacy of enpatoran in reducing cutaneous disease activity by achieving at least 70% reduction from Baseline in CLASI-A total score (CLASI-70) at Week 24.

Secondary objectives 7

1. To demonstrate the efficacy of enpatoran in reducing overall disease activity by achieving BICLA response at Week 24.
2. To evaluate safety and tolerability of enpatoran.
3. To demonstrate the fast onset of action of enpatoran in reducing cutaneous disease by achieving at least 50% reduction from Baseline in CLASI-A total score (CLASI-50) at Week 4.
4. To demonstrate the efficacy of enpatoran in the achievement of low cutaneous disease activity/remission at Week 24.
5. To evaluate the efficacy of enpatoran on reduction of cutaneous disease activity.
6. To demonstrate the efficacy of enpatoran in reducing systemic disease activity and CS use.
7. To evaluate the effect of enpatoran on itch.

Conditions and MedDRA coding

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Min. Age: 18 Years; Max. Age: 75 Years.
2. Vaccinations are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
3. Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).
4. Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.
5. Participants with diagnosis of SLE and fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.
6. For participants with SLE: - Participants with diagnosis of SLE and fulfill EULAR/ACR 2019classification criteria.
7. For participants with SLE: - Participants with disease duration (cutaneous disease and, where applicable, SLE) of >= 6 months from time of diagnosis to Screening.
8. For participants with SLE: - Participants with CLASI-A score >= 8 at Screening and Day 1 visits.
9. For participants with SLE: - Other protocol-defined inclusion criteria may apply.

Exclusion criteria 7

1. Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.
2. Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), or 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.
3. Participants with drug-induced lupus (SLE or CLE).
4. Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate, azathioprine or an oral calcineurin inhibitor is allowed).
5. Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.
6. Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.
7. Other protocol-defined exclusion criteria may apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 at Week 24.

Secondary endpoints 6

1. Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 24.
2. Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [ Time Frame: From Day 1 to Week 24 ].
3. Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [ Time Frame: From Day 1 to Week 24 ].
4. Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24.
5. Percentage of Participants WithCLASI-50 Response, Defined as>=50% Decrease in CLASI-A Score From Baseline at Weeks 4 and 24.
6. Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [ Time Frame: Day 1 up to Week 12 and thereafter up to Week 24 ].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Healthcare KGaA

Sponsor organisation

Merck Healthcare KGaA

Address

Frankfurter Strasse 250

City

Darmstadt

Postcode

64293

Country

Germany

Scientific contact point

Organisation

Merck Healthcare KGaA

Contact name

Global Regulatory Affairs

Public contact point

Organisation

Merck Healthcare KGaA

Contact name

Global Regulatory Affairs

Third parties 17

Locations

6 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 190 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications