Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

Atopic Dermatitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05469464
• Other study ID #: UNI50001-202
• Secondary ID: 2021-006707-15
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 11, 2022
• Est. completion date: February 16, 2024

Study information

• Verified date: July 2023
• Source: UNION therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: February 16, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Capable of giving signed informed consent.

2. Male and female patients =18 years of age

3. Body weight of >40 kg

4. Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria

5. Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits

6. Candidate for systemic treatment or phototherapy for AD

Exclusion Criteria:

1. Therapy-resistant atopic dermatitis

2. Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization

3. History of allergy or hypersensitivity to any component of the study treatment

4. Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit

5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Diseases

Intervention

Drug:
• Orismilast modified release tablets
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: UNI50001 LEO32731
• Placebo
Placebo matching tablets

Locations

Country	Name	City	State
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	ISA - Interdisciplinary Study Association GmbH	Berlin
Germany	Rosenpark Research GmbH	Darmstadt
Germany	Hautarztpraxis Dr.Gerlach	Dresden	Sachsen
Germany	TFS Trial From Support GmbH	Hamburg
Germany	MVZ DermaKiel GmbH	Kiel	Schleswig-Holstein
Germany	Studienzentrum Dr.Beate Schwarz	Langenau
Germany	Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie	Munich
Germany	KliFOs - Klinische Forschung Osnabrueck	Osnabrück
Hungary	Obudai Egeszsegugyi Centrum	Budapest
Hungary	Dermamed Research Kft	Oroshaza
Hungary	PTE AOK	Pecs
Hungary	Obudai Egeszsegugyi Centrum	Zalaegerszeg
Poland	NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL	Bialystok
Poland	Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska	Chorzów
Poland	Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.	Iwonicz-Zdrój
Poland	Provita Sp. z o.o.	Katowice
Poland	Centrum Medyczne All-Med	Kraków
Poland	Maxxmed Centrum Zdrowia i Urody	Lubin
Poland	Klinika Badawcza	Malbork
Poland	Centrum Medyczne Grunwald	Poznan
Poland	Solumed Centrum Medyczne	Poznan
Poland	Laser Clinic	Szczecin
Poland	Clinical Best Solutions	Warsaw
Poland	Clinical Research Group Sp. z o.o.	Warsaw
Poland	Klinika Ambroziak	Warsaw
Poland	Royalderm Agnieszka Nawrocka	Warsaw
Poland	CityClinic Przychodnia Lekarsko-Psychologiczna	Wroclaw
Poland	dermMedica Sp z.o.o	Wroclaw
Poland	Wromedica	Wroclaw
United States	ALLCUTIS Research, LLC	Beverly	Massachusetts
United States	Hope Clinical Research	Canoga Park	California
United States	First OC Dermatology Research Inc	Fountain Valley	California
United States	Clinical Trial Network	Houston	Texas
United States	Axon Clinical Research	Inglewood	California
United States	Excel Clinical Research	Las Vegas	Nevada
United States	LA Universal Research Center, INC.	Los Angeles	California
United States	Apex Clinical Research Center	Mayfield Heights	Ohio
United States	Advance Medical Research Center	Miami	Florida
United States	Juva Skin & Laser Center	New York	New York
United States	Sadick Research Group LLC	New York	New York
United States	ALLCUTIS Research, LLC	Portsmouth	New Hampshire
United States	Acclaim Clinical Research Inc.	San Diego	California
United States	Alliance Clinical Research of Tampa	Tampa	Florida
United States	Clinical Research Trials of Florida ,Inc.	Tampa	Florida
United States	Revival Research Institute, LLC	Troy	Michigan
United States	Michigan Dermatology Institute	Waterford	Michigan
United States	Tranquility Research	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
UNION therapeutics

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16.	The EASI is a measure of atopic dermatitis disease severity, taking into account qualitative lesion characteristics and percentage of affected skin surface area on defined anatomical regions.	Day 1 to Week 16
Secondary	Patients achieving 75% reduction in EASI (EASI75) response at Week 16		Day 1 to Week 16
Secondary	Patients achieving a score of clear (0) or almost clear (1) and at least a 2-point improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16		Day 1 to Week 16