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

UNION Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Atopic Dermatitis; Skin Diseases

Treatments: Drug: Orismilast modified release tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05469464

UNI50001-202

2021-006707-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 4 patient groups, including a placebo group

Orismilast modified release tablets 20 mg BID

Experimental group

Description:

Oral, twice daily morning and evening

Treatment:

Drug: Orismilast modified release tablets

Orismilast modified release tablets 30 mg BID

Experimental group

Description:

Oral, twice daily morning and evening

Treatment:

Drug: Orismilast modified release tablets

Orismilast modified release tablets 40 mg BID

Experimental group

Description:

Oral, twice daily morning and evening

Treatment:

Drug: Orismilast modified release tablets

Placebo tablets BID

Placebo Comparator group

Description:

Oral, twice daily morning and evening

Treatment:

Drug: Placebo