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Completed

NCT Number: NCT05469464

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hautarztpraxis Dr.Gerlach, Dresden, Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orismilast modified release tablets

Drug

Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation.

Other Names:

  • UNI50001
  • LEO32731

Placebo

Drug

Placebo matching tablets

Primary outcomes

  1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16

    Time frame: Baseline and Week 16

    The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

Secondary outcomes

  1. Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16

    Time frame: At Week 16

    The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  2. 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

    Time frame: At Week 16

    The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe).

  3. 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

    Time frame: At Weeks 2, 4, 8, 12, and 20

    The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe).

  4. Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20

    Time frame: At Weeks 2, 4, 8, 12, and 20

    The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  5. Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: At Weeks 2, 4, 8, 12, 16, and 20

    The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  6. Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: At Weeks 2, 4, 8, 12, 16, and 20

    The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  7. Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, and 20

    The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).

  8. Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20

    Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20

    The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their "worst itching due to AD over the past 24 hours" on an NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).

  9. 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

    Time frame: At Weeks 1, 2, 4, 8, 12, 16 and 20

    The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their "worst itching due to AD over the past 24 hours" on an NRS anchored by the terms "no itching" (0) and "worst possible itching" (10).

  10. Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20

    The BSA assessment estimated the extent of disease or skin affected by AD and was expressed as a percentage of total BSA. BSA was determined by the Investigator or designee using the participant's hand (palm + fingers) = 1% BSA rule.

  11. Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20

    Time frame: Baseline and Weeks 8, 16, and 20

    The DLQI is a 10-item validated questionnaire completed by the patient and used to assess the effect of skin disease on the patient's quality of life during the previous week. The 10 questions cover the following topics: symptoms; embarrassment; interference with shopping and home care, clothing choices, social and leisure activities, sports participation, work or study, close relationships, and sex; and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much," respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor quality of life.

  12. Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20

    The POEM is a 7-item, validated questionnaire completed by the patient to assess disease symptoms. Patients were asked to respond to questions on frequency of sleep loss and skin dryness, itching, flaking, cracking, bleeding, and weeping over the past week. All answers carry equal weight, with a total possible score ranging from 0 to 28. A high score is indicative of a poor quality of life.

  13. Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20

    The PGIS scale is a single question asking the patient how he or she would rate his or her overall AD symptoms over the past 24 hours. The 5 categories of responses are (0) "no symptoms", (1) "very mild", (2) "mild", (3) "moderate", and (4) "severe."

  14. Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20

    The PGIC scale measures change in clinical status of AD. The PGIC is based on a 7-point scale, and the patient will rate the change from the start of treatment as 1 "very much improved," 2 "much improved," 3 "minimally improved," 4 "no change," 5 "minimally worse," 6 "much worse," and 7 "very much worse."

  15. Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20

    The sleep disturbance NRS is a scale used by the patients to report their degree of sleep loss related to AD. Patients were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being "no sleep loss related to signs/symptoms of AD" and 10 being "I cannot sleep at all because of the signs/symptoms of AD". Higher scores indicate worse outcomes.

  16. Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20

    The skin pain NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number that best describes the worst level of skin pain in the past 24 hours.

  17. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    Time frame: From Baseline through Week 20

    An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event.

  18. Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16

    Time frame: At Week 16

    A complete physical examination (a check of the head, eyes, ears, nose, and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems) was performed at screening (Visit 1) and Weeks 16.

  19. Change From Baseline in Body Temperature at Weeks 16 and 20

    Time frame: Baseline and Weeks 16 and 20

    A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Weeks 16 and 20.

  20. Change From Baseline in Respiration Rate at Weeks 16 and 20

    Time frame: Baseline and Weeks 16 and 20

    A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.

  21. Change From Baseline in Heart Rate at Weeks 16 and 20

    Time frame: Baseline and Weeks 16 and 20

    A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.

  22. Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20

    Time frame: Baseline and Weeks 16 and 20

    A complete physical examination that included systolic and diastolic blood pressure measurements was performed at screening (Visit 1) and Weeks 16 and 20.

  23. Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20

    Time frame: Baseline and Weeks 16 and 20

    A complete physical examination that included BMI measurements was performed at screening (Visit 1) and Weeks 16 and 20.

  24. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16

    Time frame: At Week 16

    Electrocardiograms were assessed by the investigators based on automatically generated parameters.

  25. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  26. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  27. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  28. Change From Baseline in Hematology Parameter: Hematocrit at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  29. Change From Baseline in Hematology Parameter: Hemoglobin at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  30. Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  31. Change From Baseline in Hematology Parameter: Platelets at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  32. Change From Baseline in Hematology Parameter: Reticulocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  33. Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  34. Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  35. Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  36. Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  37. Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including hematology was evaluated at baseline and at Week 16.

  38. Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  39. Change From Baseline in Chemistry Parameter: Albumin at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  40. Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  41. Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  42. Change From Baseline in Chemistry Parameter: Phosphate at Week 16

    Time frame: Baseline and Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  43. Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16

    Time frame: At Week 16

    Laboratory parameters including chemistry was evaluated at baseline and at Week 16.

  44. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20

    Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20

    The HADS is a patient reported outcome, comprises of 7 questions for anxiety and 7 questions for depression, with each answer graded from 0 to 3 with a higher score indicating a worse condition. For each group of questions, scores of 7 or less indicate cases without anxiety or depression, whereas scores of 8 to 10, 11 to 14, and 15 to 21 indicate mild, moderate, and severe cases, respectively.

  45. 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)

    Time frame: At Weeks 2, 4, 8, 12, 16, and 20

    The C-SSRS, Investigator-administered version, was designed to provide a prospective, standardized measure of suicidality. C-SSRS is administered in the form of a clinical interview. The C-SSRS categories have been re-ordered from the actual scale to facilitate the definitions of the endpoints, and to enable clarity in the presentation of the results: Category 1 - Wish to be Dead, Category 2 - Non-specific Active Suicidal Thoughts, Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Category 5 - Active Suicidal Ideation with Specific Plan and Intent, Category 6 - Preparatory Acts or Behavior, Category 7 - Aborted Attempt, Category 8 - Interrupted Attempt, Category 9 - Actual Attempt (non-fatal), Category 10 - Completed Suicide.

Sponsors and collaborators

Lead sponsor

UNION therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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