Clinical trial NCT05469464: Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Skin Diseases
Keywords: Atopic Dermatitis
Orismilast
Lead sponsor: UNION therapeutics
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16
timeFrame: At Week 16
measure: Percentage of Participants 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
timeFrame: At Week 16
measure: Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20
timeFrame: At Weeks 2, 4, 8, 12, and 20
measure: Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20
timeFrame: At Weeks 2, 4, 8, 12, and 20
measure: Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: At Weeks 2, 4, 8, 12, 16, and 20
measure: Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: At Weeks 2, 4, 8, 12, 16, and 20
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, and 20
measure: Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20
measure: Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20
timeFrame: At Weeks 1, 2, 4, 8, 12, 16 and 20
measure: Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20
timeFrame: Baseline and Weeks 8, 16, and 20
measure: Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
measure: Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
measure: Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
measure: Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
measure: Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: From Baseline through Week 20
measure: Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16
timeFrame: At Week 16
measure: Change From Baseline in Body Temperature at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Change From Baseline in Respiration Rate at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Change From Baseline in Heart Rate at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20
timeFrame: Baseline and Weeks 16 and 20
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16
timeFrame: At Week 16
measure: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Hematocrit at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Hemoglobin at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Platelets at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Reticulocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Chemistry Parameter: Albumin at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Chemistry Parameter: Phosphate at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16
timeFrame: At Week 16
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
measure: Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At Weeks 2, 4, 8, 12, 16, and 20
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center, INC.
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research Inc.
state: California
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ,Inc.
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Beverly
country: United States
facility: ALLCUTIS Research, LLC
state: Massachusetts
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Portsmouth
country: United States
facility: ALLCUTIS Research, LLC
state: New Hampshire
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
city: New York
country: United States
facility: Sadick Research Group LLC
state: New York
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Webster
country: United States
facility: Tranquility Research
state: Texas
city: Dresden
country: Germany
facility: Hautarztpraxis Dr.Gerlach
state: Sachsen
city: Kiel
country: Germany
facility: MVZ DermaKiel GmbH
state: Schleswig-Holstein
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: ISA - Interdisciplinary Study Association GmbH
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Hamburg
country: Germany
facility: TFS Trial From Support GmbH
city: Langenau
country: Germany
facility: Studienzentrum Dr.Beate Schwarz
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrueck
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum
city: Oroshaza
country: Hungary
facility: Dermamed Research Kft
city: Pecs
country: Hungary
facility: PTE AOK
city: Zalaegerszeg
country: Hungary
facility: Obudai Egeszsegugyi Centrum
city: Białystok
country: Poland
facility: NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
city: Chorzów
country: Poland
facility: Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
city: Iwonicz-Zdrój
country: Poland
facility: Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Kraków
country: Poland
facility: Centrum Medyczne All-Med
city: Lubin
country: Poland
facility: Maxxmed Centrum Zdrowia i Urody
city: Malbork
country: Poland
facility: Klinika Badawcza
city: Poznan
country: Poland
facility: Centrum Medyczne Grunwald
city: Poznań
country: Poland
facility: Solumed Centrum Medyczne
city: Szczecin
country: Poland
facility: Laser Clinic
city: Warsaw
country: Poland
facility: Clinical Research Group Sp. z o.o.
city: Warsaw
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Warsaw
country: Poland
facility: Clinical Best Solutions
city: Warsaw
country: Poland
facility: Klinika Ambroziak
city: Wrocław
country: Poland
facility: CityClinic Przychodnia Lekarsko-Psychologiczna
city: Wrocław
country: Poland
facility: dermMedica Sp z.o.o
city: Wrocław
country: Poland
facility: Wromedica
Study officials:
affiliation: UNION therapeutics A/S
name: P. A. MD
role: STUDY_DIRECTOR
References: