Study on the Effects of LEO 138559 for Adults with Moderate-to-Severe Atopic Dermatitis

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What is this study about?

This clinical trial is focused on studying atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. The trial will evaluate a new treatment called LEO138559, which is a solution for injection. This treatment is a type of protein known as a humanised IgG1 monoclonal antibody that targets a specific part of the immune system involved in atopic dermatitis. The study will compare the effects of different doses of LEO138559 with a placebo to understand its safety and effectiveness in treating moderate-to-severe atopic dermatitis in adults.

The purpose of the study is to find out how well LEO138559 works and how safe it is for people with moderate-to-severe atopic dermatitis. Participants in the study will receive injections of either LEO138559 or a placebo. The study will last for 16 weeks, during which participants will be monitored to see how their skin condition changes over time. The main focus will be on the percentage change in the severity of the skin condition from the start of the study to the end of the 16 weeks.

Throughout the study, researchers will also keep track of any side effects that participants might experience. This information will help determine the safety of LEO138559 and its potential as a treatment option for atopic dermatitis. The study aims to provide valuable insights into managing this skin condition and improving the quality of life for those affected by it.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of atopic dermatitis (AD), and previous treatment history.

The study is designed for adults aged 18 to 75 with moderate-to-severe AD, as defined by specific clinical criteria.

2 initial assessment

An initial assessment is conducted to evaluate the severity of AD using scores like EASI and vIGA-AD.

The extent of skin involvement and itch severity are also measured.

3 randomization and treatment allocation

Participants are randomly assigned to receive either the investigational drug LEO138559 or a placebo.

LEO138559 is a solution for injection administered subcutaneously, with a concentration of 150 mg/ml.

4 treatment administration

The treatment involves subcutaneous injections of LEO138559 or placebo, following one of four different dosage regimens.

The specific dosage and frequency are determined by the study protocol.

5 monitoring and follow-up

Participants are monitored regularly to assess the efficacy and safety of the treatment.

The primary measure of efficacy is the percent change in the EASI score from baseline to Week 16.

6 safety assessment

Safety is evaluated by recording the number of treatment-emergent adverse events (TEAEs) from baseline to Week 16.

Regular follow-up visits are scheduled to ensure participant safety and to collect necessary data.

7 completion of the study

The study is expected to conclude by March 31, 2025.

Final assessments are conducted to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

  • Must be between 18 and 75 years old at the time of the first visit.
  • Must have a diagnosis of Atopic Dermatitis (AD) according to specific criteria and have had AD for at least 1 year.
  • Must have tried treatment with Topical Corticosteroids (TCS) within the last 12 months, and either not responded well or been unable to use them due to side effects or safety concerns. Topical Corticosteroids are creams or ointments used to reduce inflammation and itching.
  • Must have an EASI score of 12 or higher at the first visit and 16 or higher at the start of the study. The EASI score measures the severity of eczema.
  • Must have a vIGA-AD score of 3 or higher at both the first visit and the start of the study. The vIGA-AD score is a way to assess the overall severity of AD.
  • Must have Body Surface Area (BSA) involvement of 10% or more at both the first visit and the start of the study. BSA refers to the percentage of the body affected by AD.
  • Must have an ADSD Worst Itch score of 4 or higher on average over a week at the start of the study. This score measures the intensity of itching.

Who Cannot Join 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
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Medicus Sp. z o.o. Wroclaw Poland
Newderm Clinic S.R.L. Timisoara Romania

Other Sites

Site Name City Country Status
Praglandia s.r.o. Prague Czechia
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Hospital Universitari de Bellvitge L'hospitalet De Llobregat Spain
University Of Pecs Pecs Hungary
Centre Hospitalier Universitaire Rouen Rouen France
University Of Debrecen Debrecen Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Clintrial s.r.o. Prague Czechia
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Charite Research Organisation GmbH Berlin Germany
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Dermamedica s.r.o. Nachod Czechia
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Blankenfelde-Mahlow Germany
Accellacare Espana S.L. Alcobendas Spain
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Tagast 41 Nice France
St-Inspire Sp. z o.o. Mikolow Poland
Du Docteur Ruer S.E.L.A.R.L. Martigues France
Dermatologiczna Praktyka Lekarska Michal Torz, DERMACEUM Centrum Badan Klinicznych Wroclaw Poland
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Urwtnuqvmfwoxfpzitslu Ayxbklat Augsburg Germany
Cdk Louccpqpp Iasi Romania
Cbuyph Hvodipgimsu Ufxdaqfzgqdiu Db Dgvmr Dijon France
Aqcttwpomz Pdmcbmhs Hlnghqia Da Phyex Paris France
Glkjzt Udqccypogi Falujsjad Frankfurt Germany
Fdzsxmdyz Pjln Lc Igriaucjrbits Bjdodhyon Dld Hcgththw Utbalrkshtgzw Ls Pqz Madrid Spain
Tydosyjlogn uzt Shbengiuzhw Bpgmnuar Gsfe Bad Bentheim Germany
Hqfmlkfy Unjxnbejjcutr Hikljzyb Tpeot y Pkusbp Iubvqbzz Cwoppi dksapismajhkxzlet (fyop Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
30.10.2023
France France
Not recruiting
30.10.2023
Germany Germany
Not recruiting
30.10.2023
Hungary Hungary
Not recruiting
30.10.2023
Poland Poland
Not recruiting
30.10.2023
Romania Romania
Not recruiting
30.10.2023
Spain Spain
Not recruiting
30.10.2023

Trial locations

LEO 138559 is an investigational medication being studied for its potential to treat moderate-to-severe atopic dermatitis, a skin condition characterized by red, inflamed, and itchy skin. This medication is administered through an injection under the skin. The trial aims to determine how effective and safe LEO 138559 is when given in different dosage regimens to adults suffering from this condition.

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:
2022-500777-14-00
Protocol code:
LP0145-2240
Trial Phase:
Therapeutic exploratory (Phase II)

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