Study on IMVT-1402 for Patients with Active Cutaneous Lupus Erythematosus

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What is this study about?

This clinical trial is focused on studying a condition known as Cutaneous Lupus Erythematosus (CLE), which affects the skin and can sometimes have other body symptoms. The study will explore the effects of a treatment called IMVT-1402, which is given as a solution for injection under the skin. The trial will compare the effects of IMVT-1402 to a placebo in participants with active forms of CLE, specifically Subacute Cutaneous Lupus Erythematosus (SCLE) and Chronic Cutaneous Lupus Erythematosus (CCLE).

The purpose of the study is to evaluate how well IMVT-1402 works in improving the condition of participants with CLE. Participants will receive either the treatment or a placebo, and the study will monitor changes in their skin condition over time. The trial will last for up to 52 weeks, during which participants will have regular check-ups to assess their response to the treatment.

Throughout the study, the main focus will be on the safety and tolerability of IMVT-1402, as well as its effectiveness in reducing the severity of skin symptoms associated with CLE. The study aims to provide valuable information on whether IMVT-1402 can be a beneficial treatment option for individuals living with this skin condition.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the investigational medication IMVT-1402 or a placebo. A placebo looks like the investigational medication but does not contain any active ingredients.

2 medication administration

The medication, whether IMVT-1402 or placebo, will be given as a solution for injection under the skin, known as a subcutaneous injection.

The frequency and dosage of the medication will be determined by the study protocol, and you will be informed of the schedule by the study team.

3 monitoring and assessments

Throughout the study, your condition will be monitored regularly. This includes assessments of your skin condition using a scoring system called CLASI-A, which measures the severity of your skin symptoms.

These assessments will occur at various points, including at the start of the study and at week 12, to evaluate any changes in your condition.

4 end of study participation

Your participation in the study will continue until the study’s estimated end date, which is April 1, 2027, unless you choose to withdraw earlier.

At the end of your participation, a final assessment will be conducted to evaluate the overall impact of the treatment on your condition.

Who Can Join the Study?

Must have a documented diagnosis of either SCLE (Subacute Cutaneous Lupus Erythematosus) or CCLE (Chronic Cutaneous Lupus Erythematosus) confirmed by a skin biopsy. A biopsy is a small sample of skin taken for testing.
Must have a CLASI-A score of 10 or higher at the start of the study. The CLASI-A score is a way to measure the severity of skin symptoms in lupus. If the score is between 8 and 10, it should not include hair loss or mouth sores.
Must have active CLE (Cutaneous Lupus Erythematosus) despite trying standard treatments like corticosteroids or antimalarial drugs for at least 12 weeks, or must have stopped these treatments due to side effects or poor tolerance.
Must test positive for at least one of the following at the start of the study:
- ANA (Antinuclear Antibody)
- Elevated anti-double-stranded DNA
- Anti-Ro/SSA
- Anti-La/SSB
- Anti-Sm
- Anti-RNP70
- Positive direct immunofluorescence test showing IgG (a type of antibody) in a skin biopsy
Open to both male and female participants.
Participants should not belong to a vulnerable population.

Who Cannot Join the Study?

Participants cannot join the study if they have any other serious health conditions that might interfere with the study.
Participants who are pregnant or breastfeeding are not allowed to take part in the study.
Participants who have used certain medications recently that might affect the study results cannot participate.
Participants with a history of allergic reactions to similar treatments are excluded.
Participants who are currently involved in another clinical trial are not eligible.
Participants with a history of drug or alcohol abuse may not join the study.
Participants who have had a recent major surgery are not allowed to participate.
Participants with unstable mental health conditions are excluded from the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
St. Josef-Hospital	Bochum	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
University General Hospital Of Heraklion	Heraklion	Greece
Imed Valencia	Burjassot	Spain
Somed Cr Sp. z o.o. sp.k.	Lodz	Poland
General University Hospital Of Larissa	Larissa	Greece
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Synexus Polska Sp. z o.o.	Poznan	Poland
Diagnostic Consultation Center XX-Sofia EOOD	Sofia	Bulgaria
Hospital Vithas Parque San Antonio	Malaga	Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Dermoklinika-Centrum Medyczne s.c	Lodz	Poland
Klinika Osipowicz & Turkowski Sp. z o.o.	Warsaw	Poland
Mkqpywvsh Imbaqsleri Ccdopujc Shrybzuf Sbq z okce	Warsaw	Poland
Eltqcasqsp Kzfgpkw Sykmxjn	Thessaloniki	Greece
Psggbuk Byftvx Cuxnen snl	Gorzów Wielkopolski	Poland
Msxbdftz Mgcwcnk Avjqmeu	Pleven	Bulgaria
Hteblrgc Uupywwgbxsmjp Hzdkozvr Tbdif y Pccwfw Iwpmcrpo Cceggo difvhtpngnrshtggt (srob	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	31.07.2025
Germany	Not recruiting	31.07.2025
Greece	Not recruiting	31.07.2025
Poland	Not recruiting	31.07.2025
Spain	Not recruiting	31.07.2025

Trial locations

Investigated drugs:

IMEROPRUBART

IMVT-1402 is a medication being studied for its potential to help people with certain types of lupus, specifically subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE). These are conditions where the immune system mistakenly attacks the skin, causing rashes and other skin problems. IMVT-1402 is designed to reduce the activity of the immune system, which may help to lessen the skin symptoms and possibly other related symptoms of lupus. The goal of using IMVT-1402 in this study is to see if it can improve the skin condition of people with lupus compared to those who do not receive the medication.

Investigated diseases:

Cutaneous lupus erythematosus

Cutaneous lupus erythematosus – This is a chronic autoimmune disease that primarily affects the skin, causing inflammation and a variety of skin lesions. The disease can manifest as red, scaly patches or plaques, often on sun-exposed areas such as the face, neck, and arms. Over time, these lesions may lead to scarring and changes in skin pigmentation. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more extensive skin involvement. The progression of the disease can be unpredictable, with periods of flare-ups and remissions. Environmental factors, such as sun exposure, can exacerbate the symptoms.

Trial ID:

2024-516745-39-00

Protocol code:

IMVT-1402-2701

NCT ID:

NCT06980805

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on IMVT-1402 for Patients with Active Cutaneous Lupus Erythematosus

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