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

Sponsor

UNION therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05469464

Collaborator

(none)

210

Enrollment

Locations

Arms

11.3

Anticipated Duration (Months)

5.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Skin Diseases	Drug: Orismilast modified release tablets Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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).

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

Jun 5, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orismilast modified release tablets 20 mg BID Oral, twice daily morning and evening	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
Experimental: Orismilast modified release tablets 30 mg BID Oral, twice daily morning and evening	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
Experimental: Orismilast modified release tablets 40 mg BID Oral, twice daily morning and evening	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 Comparator: Placebo tablets BID Oral, twice daily morning and evening	Drug: Placebo Placebo matching tablets

Outcome Measures

Primary Outcome Measures

Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16. [Day 1 to 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 [Day 1 to 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 [Day 1 to Week 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hope Clinical Research	Canoga Park	California	United States	91303
2	Acclaim Clinical Research Inc.	San Diego	California	United States	92120
3	Advance Medical Research Center	Miami	Florida	United States	33135
4	ALLCUTIS Research, LLC	Beverly	Massachusetts	United States	01915
5	Excel Clinical Research	Las Vegas	Nevada	United States	89109
6	ALLCUTIS Research, LLC	Portsmouth	New Hampshire	United States	03801
7	Juva Skin & Laser Center	New York	New York	United States	10022
8	Sadick Research Group LLC	New York	New York	United States	10075
9	Apex Clinical Research Center	Mayfield Heights	Ohio	United States	44124
10	Clinical Trial Network	Houston	Texas	United States	77074
11	Hautarztpraxis Dr.Gerlach	Dresden	Sachsen	Germany	1097
12	MVZ DermaKiel GmbH	Kiel	Schleswig-Holstein	Germany	24148
13	Fachklinik Bad Bentheim	Bad Bentheim		Germany
14	ISA - Interdisciplinary Study Association GmbH	Berlin		Germany
15	Rosenpark Research GmbH	Darmstadt		Germany
16	TFS Trial From Support GmbH	Hamburg		Germany
17	Studienzentrum Dr.Beate Schwarz	Langenau		Germany
18	Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie	Munich		Germany
19	KliFOs - Klinische Forschung Osnabrueck	Osnabrück		Germany
20	Obudai Egeszsegugyi Centrum	Budapest		Hungary
21	Dermamed Research Kft	Oroshaza		Hungary
22	PTE AOK	Pecs		Hungary
23	Obudai Egeszsegugyi Centrum	Zalaegerszeg		Hungary
24	NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL	Białystok		Poland
25	Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska	Chorzów		Poland
26	Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.	Iwonicz-Zdrój		Poland
27	Provita Sp. z o.o.	Katowice		Poland
28	Centrum Medyczne All-Med	Kraków		Poland
29	Maxxmed Centrum Zdrowia i Urody	Lubin		Poland	20-080
30	Klinika Badawcza	Malbork		Poland
31	Centrum Medyczne Grunwald	Poznan		Poland	60-369
32	Solumed Centrum Medyczne	Poznań		Poland	60-529
33	Laser Clinic	Szczecin		Poland
34	ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.	Tarnów		Poland
35	Clinical Research Group Sp. z o.o.	Warsaw		Poland	01-142
36	Royalderm Agnieszka Nawrocka	Warsaw		Poland	01-496
37	Clinical Best Solutions	Warsaw		Poland	02-793
38	Klinika Ambroziak	Warsaw		Poland
39	CityClinic Przychodnia Lekarsko-Psychologiczna	Wrocław		Poland
40	dermMedica Sp z.o.o	Wrocław		Poland
41	Wromedica	Wrocław		Poland