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

NCT05469464 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2025-03-07

Study results available
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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.

Conditions

Interventions

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

DRUG

Placebo

Placebo matching tablets

Sponsors & Collaborators

  • UNION therapeutics

    lead INDUSTRY

Principal Investigators

  • P. A. MD · UNION therapeutics A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2024-01-23
Completion
2024-02-15
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Hungary
  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469464 on ClinicalTrials.gov