Phase 2
Completed N=235
Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)
Atopic Dermatitis · Skin Diseases
Source: ClinicalTrials.gov NCT05469464 ↗
Enrolled (actual)
235
Serious AEs
0.9%
Results posted
Mar 2025
Primary outcomePrimary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 — -55.1; -52.2; -61.4; -50.4 percent change — p=0.505
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 |
-55.1; -52.2; -61.4; -50.4 | 0.505 |
| SECONDARY Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 |
30.4; 25.9; 36.4; 36.1; 69.6; 74.1 | — |
| SECONDARY 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 |
26.3; 24.3; 30.9; 9.5; 73.7; 75.7 | — |
| SECONDARY 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 |
1.8; 3.3; 3.4; 0.0; 98.2; 96.7 | — |
| SECONDARY Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 |
1; 4; 2; 1; 54; 56 | — |
| SECONDARY Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 |
5; 11; 11; 6; 50; 49 | — |
| SECONDARY Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 |
1; 2; 0; 0; 54; 58 | — |
| SECONDARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 |
-19.4; -21.6; -21.3; -10.8; -35.3; -32.6 | — |
| SECONDARY Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 |
-1.9; -2.0; -2.4; -1.1; -2.4; -2.8 | — |
| SECONDARY 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 |
21.4; 24.7; 31.5; 8.0; 78.6; 75.3 | — |
| SECONDARY Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 |
-2.7; -5.1; -4.4; -2.8; -7.0; -7.3 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 |
-5.8; -7.2; -6.5; -5.7; -7.5; -8.2 | — |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 |
-4.6; -5.6; -7.3; -2.9; -6.4; -6.5 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 |
-0.9; -0.8; -0.7; -0.4; -0.9; -1.0 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 |
3.0; 3.0; 3.1; 3.6; 2.9; 2.9 | — |
| SECONDARY Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 |
-1.1; -1.5; -1.5; -0.5; -2.0; -1.7 | — |
| SECONDARY Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 |
-2.0; -1.8; -1.9; -0.7; -1.9; -2.2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
44; 48; 51; 35; 37; 39 | — |
| SECONDARY Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Temperature at Weeks 16 and 20 |
-0.07; 0.05; -0.01; 0.00; -0.08; -0.05 | — |
| SECONDARY Change From Baseline in Respiration Rate at Weeks 16 and 20 |
0.1; 0.2; 0.1; 0.3; 0.1; -0.1 | — |
| SECONDARY Change From Baseline in Heart Rate at Weeks 16 and 20 |
3.3; 1.1; 4.4; -2.5; 1.4; -1.0 | — |
| SECONDARY Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 |
0.3; 1.0; -1.4; -0.1; 2.7; -0.6 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 |
-0.28; -0.13; -0.34; 0.16; -0.11; -0.15 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 |
0; 1; 1; 2; 0; 0 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 |
5.2; 5.8; 2.0; 3.0 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 |
-0.24; -0.27; -0.25; -0.14 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 |
-2.34; -2.80; -1.52; -1.52 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hematocrit at Week 16 |
-0.0125; -0.0100; -0.0061; -0.0045 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 |
-1.5; -0.2; -1.0; 0.2 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 |
0.357; -0.061; -0.372; -0.153; 0.002; 0.007 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Platelets at Week 16 |
22.5; 11.7; -1.8; -3.0 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 |
0.008; 0.025; -0.137; -0.024 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 |
0.02; 0.10; 0.01; -0.03 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 |
-0.42; -0.96; -0.35; -0.28 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 |
-0.48; 0.46; 1.05; 0.94 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 |
0.18; 0.31; 0.09; 0.29 | — |
| SECONDARY Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 |
0.72; 0.13; -0.67; -0.90 | — |
| SECONDARY Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 |
-1.5; -0.7; 1.0; -0.6; -4.8; 2.1 | — |
| SECONDARY Change From Baseline in Chemistry Parameter: Albumin at Week 16 |
-0.4; 0.0; 0.0; 0.1 | — |
| SECONDARY Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 |
0.29; 0.13; 0.32; 0.68; 2.9; 2.3 | — |
| SECONDARY Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 |
-0.021; 0.013; 0.006; -0.015; -0.2; 0.0 | — |
| SECONDARY Change From Baseline in Chemistry Parameter: Phosphate at Week 16 |
0.003; 0.045; 0.043; -0.009 | — |
| SECONDARY Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 |
-1.5; -0.5; -1.2; -0.3; -2.0; -0.9 | — |
| SECONDARY 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) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Capable of giving signed informed consent.
- Male and female patients ≥18 years of age
- Body weight of >40 kg
- Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria
- 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
- Candidate for systemic treatment or phototherapy for AD
Exclusion Criteria
- Therapy-resistant atopic dermatitis
- 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
- History of allergy or hypersensitivity to any component of the study treatment
- Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
- Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
Data sourced from ClinicalTrials.gov (NCT05469464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.