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

Primary Purpose

Atopic Dermatitis, Skin Diseases

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Orismilast modified release tablets
Placebo
Sponsored by
UNION therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Orismilast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hope Clinical ResearchRecruiting
  • First OC Dermatology Research IncRecruiting
  • Axon Clinical ResearchRecruiting
  • LA Universal Research Center, INC.Recruiting
  • Acclaim Clinical Research Inc.Recruiting
  • Advance Medical Research CenterRecruiting
  • Clinical Research Trials of Florida ,Inc.Recruiting
  • Alliance Clinical Research of TampaRecruiting
  • ALLCUTIS Research, LLCRecruiting
  • Revival Research Institute, LLCRecruiting
  • Michigan Dermatology InstituteRecruiting
  • Excel Clinical ResearchRecruiting
  • ALLCUTIS Research, LLCRecruiting
  • Juva Skin & Laser CenterRecruiting
  • Sadick Research Group LLCRecruiting
  • Apex Clinical Research CenterRecruiting
  • Clinical Trial NetworkRecruiting
  • Tranquility ResearchRecruiting
  • Hautarztpraxis Dr.GerlachRecruiting
  • MVZ DermaKiel GmbHRecruiting
  • Fachklinik Bad BentheimRecruiting
  • ISA - Interdisciplinary Study Association GmbHRecruiting
  • Rosenpark Research GmbHRecruiting
  • TFS Trial From Support GmbHRecruiting
  • Studienzentrum Dr.Beate SchwarzRecruiting
  • Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und AllergologieRecruiting
  • KliFOs - Klinische Forschung OsnabrueckRecruiting
  • Obudai Egeszsegugyi CentrumRecruiting
  • Dermamed Research KftRecruiting
  • PTE AOKRecruiting
  • Obudai Egeszsegugyi CentrumRecruiting
  • NZOZ Specjalistyczny Orodek Dermatologiczny DERMALRecruiting
  • Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta GebskaRecruiting
  • Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.Recruiting
  • Provita Sp. z o.o.Recruiting
  • Centrum Medyczne All-MedRecruiting
  • Maxxmed Centrum Zdrowia i UrodyRecruiting
  • Klinika BadawczaRecruiting
  • Centrum Medyczne GrunwaldRecruiting
  • Solumed Centrum MedyczneRecruiting
  • Laser ClinicRecruiting
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
  • Clinical Research Group Sp. z o.o.Recruiting
  • Royalderm Agnieszka NawrockaRecruiting
  • Clinical Best SolutionsRecruiting
  • Klinika AmbroziakRecruiting
  • CityClinic Przychodnia Lekarsko-PsychologicznaRecruiting
  • dermMedica Sp z.o.oRecruiting
  • WromedicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Orismilast modified release tablets 20 mg BID

Orismilast modified release tablets 30 mg BID

Orismilast modified release tablets 40 mg BID

Placebo tablets BID

Arm Description

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Oral, twice daily morning and evening

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patients achieving 75% reduction in EASI (EASI75) response at Week 16
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

Full Information

First Posted
July 18, 2022
Last Updated
July 12, 2023
Sponsor
UNION therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05469464
Brief Title
Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
January 19, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Skin Diseases
Keywords
Atopic Dermatitis, Orismilast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned randomly in a 1:1:1:1 ratio to receive 1 of the 3 orismilast modified release doses (20 mg, 30 mg, or 40 mg) or placebo twice daily (BID)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orismilast modified release tablets 20 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Orismilast modified release tablets 30 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Orismilast modified release tablets 40 mg BID
Arm Type
Experimental
Arm Description
Oral, twice daily morning and evening
Arm Title
Placebo tablets BID
Arm Type
Placebo Comparator
Arm Description
Oral, twice daily morning and evening
Intervention Type
Drug
Intervention Name(s)
Orismilast modified release tablets
Intervention Description
Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: UNI50001 LEO32731
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching tablets
Primary Outcome Measure Information:
Title
Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16.
Description
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.
Time Frame
Day 1 to Week 16
Secondary Outcome Measure Information:
Title
Patients achieving 75% reduction in EASI (EASI75) response at Week 16
Time Frame
Day 1 to Week 16
Title
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
Time Frame
Day 1 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History of allergy or hypersensitivity to any component of the study treatment Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UNION therapeutics A/S Study Director Study Director
Phone
+(45) 61777435
Email
clinicaltrials@uniontherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. A. MD
Organizational Affiliation
UNION therapeutics A/S
Official's Role
Study Director
Facility Information:
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
First OC Dermatology Research Inc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Axon Clinical Research
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
LA Universal Research Center, INC.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Acclaim Clinical Research Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Advance Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Clinical Research Trials of Florida ,Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Alliance Clinical Research of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
ALLCUTIS Research, LLC
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Revival Research Institute, LLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Michigan Dermatology Institute
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
ALLCUTIS Research, LLC
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Juva Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Sadick Research Group LLC
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Apex Clinical Research Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Tranquility Research
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Hautarztpraxis Dr.Gerlach
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1097
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
MVZ DermaKiel GmbH
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24148
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Rosenpark Research GmbH
City
Darmstadt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
TFS Trial From Support GmbH
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Studienzentrum Dr.Beate Schwarz
City
Langenau
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
KliFOs - Klinische Forschung Osnabrueck
City
Osnabrück
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Obudai Egeszsegugyi Centrum
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Dermamed Research Kft
City
Oroshaza
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
PTE AOK
City
Pecs
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Obudai Egeszsegugyi Centrum
City
Zalaegerszeg
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
City
Białystok
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
City
Chorzów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
City
Iwonicz-Zdrój
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Provita Sp. z o.o.
City
Katowice
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Centrum Medyczne All-Med
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Maxxmed Centrum Zdrowia i Urody
City
Lubin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Klinika Badawcza
City
Malbork
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Centrum Medyczne Grunwald
City
Poznan
ZIP/Postal Code
60-369
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Solumed Centrum Medyczne
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Laser Clinic
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
City
Tarnów
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Clinical Research Group Sp. z o.o.
City
Warsaw
ZIP/Postal Code
01-142
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Royalderm Agnieszka Nawrocka
City
Warsaw
ZIP/Postal Code
01-496
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Clinical Best Solutions
City
Warsaw
ZIP/Postal Code
02-793
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Klinika Ambroziak
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
CityClinic Przychodnia Lekarsko-Psychologiczna
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
dermMedica Sp z.o.o
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Wromedica
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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