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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
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

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fachklinik Bad Bentheim
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Bad BentheimGermanyUnknown status
ISA - Interdisciplinary Study Association GmbH
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BerlinGermanyUnknown status
Rosenpark Research Gmbh
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DarmstadtGermanyUnknown status
Hautarztpraxis Dr.Gerlach
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DresdenGermanyUnknown status
TFS Trial From Support GmbH
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HamburgGermanyUnknown status
MVZ DermaKiel GmbH
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KielGermanyUnknown status
Studienzentrum Dr.Beate Schwarz
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LangenauGermanyUnknown status
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie
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MunichGermanyUnknown status
KliFOs - Klinische Forschung Osnabrueck
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OsnabrückGermanyUnknown status
Óbudai Egészségügyi Centrum
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BudapestHungaryUnknown status
Dermamed Research Kft.
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OrosházaHungaryUnknown status
PTE AOK
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PécsHungaryUnknown status
Obudai Egeszsegugyi Centrum
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ZalaegerszegHungaryUnknown status
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
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BialystokPolandUnknown status
Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
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ChorzówPolandUnknown status
Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
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Iwonicz-ZdrójPolandUnknown status
Provita Sp z o o
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KatowicePolandUnknown status
Centrum Medyczne ALL-MED
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KrakowPolandUnknown status
Maxxmed Centrum Zdrowia i Urody
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LubinPolandUnknown status
Klinika Badawcza
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MalborkPolandUnknown status
Solumed Centrum Medyczne
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PoznanPolandUnknown status
Centrum Medyczne Grunwald
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PoznanPolandUnknown status
Laser Clinic
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SzczecinPolandUnknown status
Clinical Best Solutions
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WarsawPolandUnknown status
Royalderm Agnieszka Nawrocka
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WarsawPolandUnknown status
Clinical Research Group Sp. z o.o.
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WarsawPolandUnknown status
Klinika Ambroziak
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WarsawPolandUnknown status
CityClinic Przychodnia Lekarsko-Psychologiczna
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WroclawPolandUnknown status
WroMedica
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WroclawPolandUnknown status
dermMedica Sp. z o.o
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WroclawPolandUnknown status
Allcutis Research LLC
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BeverlyUnited StatesUnknown status
Hope Clinical Research
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Canoga ParkUnited StatesUnknown status
First Oc Dermatology Research Inc
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Fountain ValleyUnited StatesUnknown status
Clinical Trial Network
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HoustonUnited StatesUnknown status
Axon Clinical Research
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InglewoodUnited StatesUnknown status
Excel Clinical Research
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Las VegasUnited StatesUnknown status
LA Universal Research Center, Inc.
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Los AngelesUnited StatesUnknown status
Apex Clinical Research Center
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Mayfield HeightsUnited StatesUnknown status
Advance Medical Research Center
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MiamiUnited StatesUnknown status
Juva Skin & Laser Center
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New YorkUnited StatesUnknown status
Sadick Research Group, LLC
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New YorkUnited StatesUnknown status
Allcutis Research, Llc
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PortsmouthUnited StatesUnknown status
Acclaim Clinical Research, Inc.
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San DiegoUnited StatesUnknown status
Alliance Clinical Research of Tampa
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TampaUnited StatesUnknown status
Clinical Research Trials of Florida, Inc.
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TampaUnited StatesUnknown status
Revival Research Institute, LLC
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TroyUnited StatesUnknown status
Michigan Dermatology Institute
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WaterfordUnited StatesUnknown status
Tranquility Research
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WebsterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.