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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
First received
Last updated
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
Health authority
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

Study Design


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
See also
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