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

• Status: Recruiting
• Trial end date: 2023-07-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNION therapeutics

Criteria

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