Study on SAR444656 for Adults with Moderate to Severe Atopic Dermatitis

2 1

What is this study about?

This clinical trial is focused on studying a skin condition known as atopic dermatitis, which is a type of eczema that causes red, itchy, and inflamed skin. The study is testing a new treatment called SAR444656, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective and safe this treatment is for adults who have moderate to severe atopic dermatitis.

Participants in the study will receive either the new treatment, SAR444656, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of up to 16 weeks, during which participants will take the medication orally and continue using their regular moisturizers.

Throughout the study, researchers will monitor changes in the severity of the atopic dermatitis symptoms, such as the extent of skin affected and the level of itchiness. The goal is to see if SAR444656 can significantly improve these symptoms compared to the placebo. Participants will also be asked to keep an electronic diary to track their symptoms and any side effects they may experience. This information will help researchers understand the potential benefits and risks of the new treatment.

1 joining the study

Upon joining the study, you will be asked to confirm your eligibility. This involves meeting specific criteria related to your condition, such as having moderate to severe atopic dermatitis for at least one year.

You will need to have a certain level of skin involvement and a history of inadequate response to topical treatments. Daily use of a moisturizer is required before and during the study.

2 baseline assessment

At the start of the study, a baseline assessment will be conducted. This includes evaluating the severity of your skin condition using specific scoring systems.

You will also be asked to complete an electronic diary to track your symptoms and treatment progress throughout the study.

3 medication administration

You will be given a medication called SAR444656 in the form of a film-coated tablet. This medication is taken orally.

The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow the instructions carefully.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor your condition and the effects of the medication.

These assessments will include checking the severity of your skin condition and any changes in symptoms.

5 completion of the study

At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment.

You will be asked to return any unused medication and complete any remaining documentation.

Who Can Join the Study?

Participants must have atopic dermatitis (a type of skin condition) for at least 1 year before the start of the study.
Participants must have an EASI score of 12 or higher at the start of the study. EASI is a tool used to measure the severity of eczema.
Participants must have a vIGA score of 3 or higher at the start of the study. vIGA is a scale from 0 to 4 that measures the severity of skin conditions, where 3 is moderate and 4 is severe.
Participants must have atopic dermatitis affecting at least 10% of their body at the start of the study.
Participants must have a PP-NRS score of 4 or higher at the start of the study. PP-NRS is a scale used to measure itchiness.
Participants must have a history within the last 6 months of either not responding well to or being unable to use topical medications (creams or ointments applied to the skin).
Participants must have used a daily topical emollient (a moisturizer) for at least 7 days before the start of the study and should continue using it during the study.
Participants must be willing and able to complete an electronic diary for the duration of the study.
Participants must use contraception as required by local regulations if applicable.

Who Cannot Join the Study?

Patients with other skin conditions that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have used certain medications that might affect the study results.
Patients with a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Praglandia s.r.o.	Prague	Czechia
St. Josef-Hospital	Bochum	Germany
Santa Sp. z o.o.	Lodz	Poland
CCR Ostrava s.r.o.	Moravska Ostrava A Privoz	Czechia
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Elbe Kliniken Stade-Buxtehude gGmbH	Buxtehude	Germany
Staedtisches Klinikum Dessau	Dessau-Roßlau	Germany
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Pratia Pardubice a.s.	Pardubice	Czechia
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Synexus Polska Sp. z o.o.	Poznan	Poland
Pratia S.A.	Skorzewo	Poland
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Meguifjoo Iutdiuhsra Cyftstba Srngdscr Srt z osoo	Warsaw	Poland
Crqeonm Bslwe Krmsnfqcrci Phrzaamm Syu z olqr	Gdansk	Poland
Mujwwegfy Dprfyicwgipr	Remscheid	Germany
Dxigedlhb Sqc z oqqg	Wroclaw	Poland
Gracaj Upwcafcyah Fhiukmsnc	Frankfurt	Germany
Khxehkho dnp Udexljrjlfhb Mmdjpwir Akd	Munich	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	29.02.2024
Germany	Not recruiting	29.02.2024
Greece	Not recruiting	29.02.2024
Poland	Not recruiting	29.02.2024

Trial locations

Investigated drugs:

Sar444656

SAR444656 is a medication being studied for its potential to help people with moderate to severe atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin. This medication is being tested to see if it can reduce the symptoms of atopic dermatitis, such as the size and severity of skin lesions, compared to not using any active treatment. The goal is to find out if SAR444656 can make a noticeable difference in the skin condition of people who have this type of dermatitis.

Investigated diseases:

Dermatitis atopic

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin may become dry, cracked, and prone to infections due to persistent scratching. Over time, affected areas can thicken and develop a leathery texture. The condition is often associated with other allergic disorders, such as asthma and hay fever.

Trial ID:

2023-504346-66-00

Protocol code:

ACT17754

NCT ID:

NCT06058156

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on SAR444656 for Adults with Moderate to Severe Atopic Dermatitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?