NCT05469464CompletedPhase 2
Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)
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
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 235 (actual)
- First submitted
- 18 Jul 2022
- Start date
- 11 Jul 2022
- Primary completion date
- 23 Jan 2024
- Lead sponsor
- UNION therapeutics
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05469464
- EudraCT number
- 2021-006707-15
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 235
- From 11 Jul 2022 to the primary completion date, 23 Jan 2024
- 48 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Therapy-resistant atopic dermatitis
- 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
- Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
Other illness
- History of allergy or hypersensitivity to any component of the study treatment
- Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
Who the study is looking for
- Capable of giving signed informed consent.
- Male and female patients ≥18 years of age
- Body weight of \>40 kg
- Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria
- 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
- Candidate for systemic treatment or phototherapy for AD
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fachklinik Bad Bentheim Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Unknown status |
| ISA - Interdisciplinary Study Association GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Rosenpark Research Gmbh Coordinator of this site? Confirm its status | Darmstadt | Germany | Unknown status |
| Hautarztpraxis Dr.Gerlach Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| TFS Trial From Support GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| MVZ DermaKiel GmbH Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Studienzentrum Dr.Beate Schwarz Coordinator of this site? Confirm its status | Langenau | Germany | Unknown status |
| Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| KliFOs - Klinische Forschung Osnabrueck Coordinator of this site? Confirm its status | Osnabrück | Germany | Unknown status |
| Óbudai Egészségügyi Centrum Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Dermamed Research Kft. Coordinator of this site? Confirm its status | Orosháza | Hungary | Unknown status |
| PTE AOK Coordinator of this site? Confirm its status | Pécs | Hungary | Unknown status |
| Obudai Egeszsegugyi Centrum Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Unknown status |
| NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska Coordinator of this site? Confirm its status | Chorzów | Poland | Unknown status |
| Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o. Coordinator of this site? Confirm its status | Iwonicz-Zdrój | Poland | Unknown status |
| Provita Sp z o o Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Medyczne ALL-MED Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Maxxmed Centrum Zdrowia i Urody Coordinator of this site? Confirm its status | Lubin | Poland | Unknown status |
| Klinika Badawcza Coordinator of this site? Confirm its status | Malbork | Poland | Unknown status |
| Solumed Centrum Medyczne Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Centrum Medyczne Grunwald Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Laser Clinic Coordinator of this site? Confirm its status | Szczecin | Poland | Unknown status |
| Clinical Best Solutions Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Royalderm Agnieszka Nawrocka Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Clinical Research Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Klinika Ambroziak Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| CityClinic Przychodnia Lekarsko-Psychologiczna Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| WroMedica Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Allcutis Research LLC Coordinator of this site? Confirm its status | Beverly | United States | Unknown status |
| Hope Clinical Research Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| First Oc Dermatology Research Inc Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Clinical Trial Network Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Axon Clinical Research Coordinator of this site? Confirm its status | Inglewood | United States | Unknown status |
| Excel Clinical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| LA Universal Research Center, Inc. Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Apex Clinical Research Center Coordinator of this site? Confirm its status | Mayfield Heights | United States | Unknown status |
| Advance Medical Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Juva Skin & Laser Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sadick Research Group, LLC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Allcutis Research, Llc Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Acclaim Clinical Research, Inc. Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Alliance Clinical Research of Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Research Trials of Florida, Inc. Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| Michigan Dermatology Institute Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
| Tranquility Research Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.