Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

2 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib on individuals with a skin condition known as Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE). These are types of lupus that primarily affect the skin, causing rashes and lesions. The medication being tested is a film-coated tablet taken orally, and it is being evaluated in two different doses: 3 mg and 6 mg, both taken twice a day. The study also includes a comparison with a placebo to assess the medication’s effectiveness and safety.

The purpose of the study is to evaluate how well deucravacitinib works in reducing the severity of skin symptoms in participants with active DLE and/or SCLE. Participants will be randomly assigned to receive either the medication or a placebo. The study will last for a period of up to 52 weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main focus will be on the change in the severity of skin symptoms at Week 16, as measured by a specific scoring system used to assess skin disease activity.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information on the potential benefits and risks of using deucravacitinib for treating these specific types of lupus. This research could contribute to better understanding and management of DLE and SCLE, potentially offering new treatment options for those affected by these conditions.

1 joining the study

Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the medication deucravacitinib or a placebo, which is a substance with no active medication. The study is double-blind, meaning neither you nor the study team will know which group you are in.

2 medication administration

If you are assigned to the medication group, you will take deucravacitinib in the form of a film-coated tablet. The dosage will be either 3 mg or 6 mg, taken twice a day (BID), which means once in the morning and once in the evening.

The duration of the medication administration is planned for 16 weeks.

3 regular assessments

Throughout the study, your condition will be regularly assessed using a tool called the CLASI-A score. This score helps measure the activity and severity of your skin condition.

You will have scheduled visits to monitor your progress and any changes in your condition.

4 safety monitoring

Your safety is a priority. You will be monitored for any side effects or adverse events (AEs) during the study. This includes regular checks of your vital signs, laboratory tests, and heart function using an ECG (electrocardiogram).

Any serious adverse events (SAEs) will be closely observed and managed by the study team.

5 end of study

At the end of the 16-week period, your final assessment will be conducted to evaluate the overall effect of the treatment on your condition.

The study is expected to conclude by May 20, 2024.

Who Can Join the Study?

Participants must have a diagnosis of Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE).
Participants must have a CLASI-A score of 8 or higher. (CLASI-A is a tool used to measure the activity and severity of skin lupus.)
Participants must currently be receiving a stable treatment regimen for Cutaneous Lupus Erythematosus (CLE).
Both males and females can participate.
Participants must be within the specified age range for the study.

Who Cannot Join the Study?

Patients with active discoid or subacute cutaneous lupus erythematosus cannot participate. These are specific types of skin conditions related to lupus.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Assistance Publique Hopitaux De Paris	Paris	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
CHU Bordeauxt	Bordeaux	France
Nnovbvlvxxji Zxaebi Oseutu Zqlvgghov Atagiym Chakhgb Mqyajucx	Lodz	Poland
Nbnv Sueibswt Orfsltd Dcfqvxugllfuxev Dvblec	Bialystok	Poland
Huhiybg Hqpup Mvsexl &dtrhjx 1 rmt Genlgrs Eznrkc	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.03.2021
Germany	Not recruiting	31.03.2021
Poland	Not recruiting	31.03.2021

Trial locations

Investigated drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its potential to help people with certain types of lupus, specifically discoid and subacute cutaneous lupus erythematosus. Lupus is a condition where the immune system attacks the body’s own tissues, causing inflammation and damage. Deucravacitinib works by targeting specific pathways in the immune system that are involved in this process. By doing so, it aims to reduce the symptoms and severity of lupus, such as skin rashes and lesions. This medication is taken orally, and researchers are testing its effectiveness and safety in improving the condition of people with lupus over a period of time.

Investigated diseases:

Discoid Lupus Erythematosus – Discoid Lupus Erythematosus is a chronic skin condition characterized by inflamed, coin-shaped patches that can appear on the face, scalp, and other areas exposed to sunlight. These patches are often red, scaly, and may cause scarring or changes in skin color. The disease progresses with periods of flare-ups and remissions, where symptoms can worsen or improve. Over time, the affected skin may become thickened and develop a rough texture. The condition primarily affects the skin, but in some cases, it can lead to hair loss if the scalp is involved. Discoid Lupus Erythematosus is a form of Cutaneous Lupus Erythematosus, which is limited to the skin and does not affect internal organs.

Subacute Cutaneous Lupus Erythematosus – Subacute Cutaneous Lupus Erythematosus is a type of lupus that primarily affects the skin, causing red, scaly patches or ring-shaped lesions. These lesions often appear on areas of the body exposed to sunlight, such as the neck, shoulders, and arms. The condition progresses with periods of increased activity and remission, where symptoms can fluctuate in severity. Unlike Discoid Lupus, this form of lupus rarely causes scarring but can lead to changes in skin pigmentation. The lesions may be sensitive to sunlight, and exposure can exacerbate the condition. Subacute Cutaneous Lupus Erythematosus is part of the spectrum of Cutaneous Lupus Erythematosus, which affects the skin without involving internal organs.

Trial ID:

2023-504161-22-00

Protocol code:

IM011-132

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Safety and Effectiveness of Deucravacitinib for Patients with Active Discoid and/or Subacute Cutaneous Lupus Erythematosus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?