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Trial record 1 of 1 for:    NCT05469464
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Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

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ClinicalTrials.gov Identifier: NCT05469464
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
UNION therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Skin Diseases Drug: Orismilast modified release tablets Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 31, 2022
Estimated Primary Completion Date : June 5, 2023
Estimated Study Completion Date : July 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Orismilast modified release tablets 20 mg BID
Oral, twice daily morning and evening
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

Experimental: Orismilast modified release tablets 30 mg BID
Oral, twice daily morning and evening
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

Experimental: Orismilast modified release tablets 40 mg BID
Oral, twice daily morning and evening
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

Placebo Comparator: Placebo tablets BID
Oral, twice daily morning and evening
Drug: Placebo
Placebo matching tablets




Primary Outcome Measures :
  1. Percent change from Baseline in Eczema Area and Severity Index (EASI) score Week 16. [ Time Frame: Day 1 to 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.


Secondary Outcome Measures :
  1. Patients achieving 75% reduction in EASI (EASI75) response at Week 16 [ Time Frame: Day 1 to Week 16 ]
  2. 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 [ Time Frame: Day 1 to Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05469464


Contacts
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Contact: UNION therapeutics A/S Study Director Study Director +(45) 61777435 clinicaltrials@uniontherapeutics.com

Locations
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Sponsors and Collaborators
UNION therapeutics
Investigators
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Study Director: P. A. MD UNION therapeutics A/S
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Responsible Party: UNION therapeutics
ClinicalTrials.gov Identifier: NCT05469464    
Other Study ID Numbers: UNI50001-202
2021-006707-15 ( EudraCT Number )
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNION therapeutics:
Atopic Dermatitis
Orismilast
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases