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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis, Skin Diseases

Intervention / Treatment
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* Drug: Orismilast modified release tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orismilast modified release tablets 20 mg BID<br>Oral, twice daily morning and evening | Drug: Orismilast modified release tablets<br>* Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: UNI50001 LEO32731<br>|
| Experimental: Orismilast modified release tablets 30 mg BID<br>Oral, twice daily morning and evening | Drug: Orismilast modified release tablets<br>* Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: UNI50001 LEO32731<br>|
| Experimental: Orismilast modified release tablets 40 mg BID<br>Oral, twice daily morning and evening | Drug: Orismilast modified release tablets<br>* Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: UNI50001 LEO32731<br>|
| Placebo Comparator: Placebo tablets BID<br>Oral, twice daily morning and evening | Drug: Placebo<br>* Placebo matching tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Orismilast