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

NCT05469464 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: UNI50001-2022021-006707-15
• Study Type: interventional
• Target: 235
• Locations: 4 countries
• Sites: 48

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.

Conditions

Atopic Dermatitis; Skin Diseases

Keywords

Atopic Dermatitis; Orismilast

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

  The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  Baseline and Week 16

Secondary Outcomes (45)

• Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16

  At Week 16

• Percentage of Participants 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

  At Week 16

• Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20

  At Weeks 2, 4, 8, 12, and 20

• Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20

  At Weeks 2, 4, 8, 12, and 20

• Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20

  At Weeks 2, 4, 8, 12, 16, and 20

Study Arms (4)

Orismilast modified release tablets 20 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening

Drug: Orismilast modified release tablets

Orismilast modified release tablets 30 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening

Drug: Orismilast modified release tablets

Orismilast modified release tablets 40 mg BID

EXPERIMENTAL

Oral, twice daily morning and evening

Drug: Orismilast modified release tablets

Placebo tablets BID

PLACEBO COMPARATOR

Oral, twice daily morning and evening

Drug: Placebo

Interventions

Orismilast modified release tablets DRUG

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

Orismilast modified release tablets 20 mg BID; Orismilast modified release tablets 30 mg BID; Orismilast modified release tablets 40 mg BID

Placebo DRUG

Placebo matching tablets

Placebo tablets BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (48)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

First OC Dermatology Research Inc

Fountain Valley, California, 92708, United States

Location

Axon Clinical Research

Inglewood, California, 90301, United States

Location

LA Universal Research Center, INC.

Los Angeles, California, 90057, United States

Location

Acclaim Clinical Research Inc.

San Diego, California, 92120, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Clinical Research Trials of Florida ,Inc.

Tampa, Florida, 33607, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

ALLCUTIS Research, LLC

Beverly, Massachusetts, 01915, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

ALLCUTIS Research, LLC

Portsmouth, New Hampshire, 03801, United States

Location

Juva Skin & Laser Center

New York, New York, 10022, United States

Location

Sadick Research Group LLC

New York, New York, 10075, United States

Location

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Tranquility Research

Webster, Texas, 77598, United States

Location

Hautarztpraxis Dr.Gerlach

Dresden, Saxony, 1097, Germany

Location

MVZ DermaKiel GmbH

Kiel, Schleswig-Holstein, 24148, Germany

Location

Fachklinik Bad Bentheim

Bad Bentheim, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, Germany

Location

Rosenpark Research GmbH

Darmstadt, Germany

Location

TFS Trial From Support GmbH

Hamburg, Germany

Location

Studienzentrum Dr.Beate Schwarz

Langenau, Germany

Location

Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie

Munich, Germany

Location

KliFOs - Klinische Forschung Osnabrueck

Osnabrück, Germany

Location

Obudai Egeszsegugyi Centrum

Budapest, Hungary

Location

Dermamed Research Kft

Orosháza, Hungary

Location

PTE AOK

Pécs, Hungary

Location

Obudai Egeszsegugyi Centrum

Zalaegerszeg, Hungary

Location

NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL

Bialystok, Poland

Location

Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska

Chorzów, Poland

Location

Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.

Iwonicz-Zdrój, Poland

Location

Provita Sp. z o.o.

Katowice, Poland

Location

Centrum Medyczne All-Med

Krakow, Poland

Location

Maxxmed Centrum Zdrowia i Urody

Lubin, 20-080, Poland

Location

Klinika Badawcza

Malbork, Poland

Location

Centrum Medyczne Grunwald

Poznan, 60-369, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Laser Clinic

Szczecin, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, 01-142, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 01-496, Poland

Location

Clinical Best Solutions

Warsaw, 02-793, Poland

Location

Klinika Ambroziak

Warsaw, Poland

Location

CityClinic Przychodnia Lekarsko-Psychologiczna

Wroclaw, Poland

Location

dermMedica Sp z.o.o

Wroclaw, Poland

Location

Wromedica

Wroclaw, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: UNION therapeutics A/S
• Organization: UNION therapeutics A/S

clinicaltrials@uniontherapeutics.com

+45 61 77 7435

Study Officials

• P. A. MD

  UNION therapeutics A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 21, 2022
• Study Start: July 11, 2022
• Primary Completion: January 23, 2024
• Study Completion: February 15, 2024
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9); HU (4); PL (17); US (18)