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

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UNION Therapeutics

Status and phase

Active, not recruiting
Phase 2

Conditions

Atopic Dermatitis
Skin Diseases

Treatments

Drug: Placebo
Drug: Orismilast modified release tablets

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

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

Trial contacts and locations

48

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Central trial contact

UNION therapeutics A/S Study Director Study Director

Data sourced from clinicaltrials.gov

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