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

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Orismilast modified release tablets

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bad Bentheim, Germany
    • Fachklinik Bad Bentheim
  • Berlin, Germany
    • ISA - Interdisciplinary Study Association GmbH
  • Darmstadt, Germany
    • ROSENPARK RESEARCH GmbH
  • Hamburg, Germany
    • TFS Trial From Support GmbH
  • Langenau, Germany
    • Studienzentrum Dr.Beate Schwarz
  • Munich, Germany
    • Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie
  • Osnabrück, Germany
    • KliFOs - Klinische Forschung Osnabrueck
  • Sachsen
    • Dresden, Sachsen, Germany, 1097
      • Hautarztpraxis Dr.Gerlach
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24148
      • MVZ DermaKiel GmbH
• Hungary
  • Budapest, Hungary
    • Óbudai Egészségügyi Centrum
  • Oroshaza, Hungary
    • DermaMed Research Kft
  • Pecs, Hungary
    • PTE AOK
  • Zalaegerszeg, Hungary
    • Óbudai Egészségügyi Centrum
• Poland
  • Białystok, Poland
    • NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL
  • Chorzów, Poland
    • Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska
  • Iwonicz-Zdrój, Poland
    • Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.
  • Katowice, Poland
    • Provita Sp. z o.o.
  • Kraków, Poland
    • Centrum Medyczne All-Med
  • Lubin, Poland, 20-080
    • Maxxmed Centrum Zdrowia i Urody
  • Malbork, Poland
    • Klinika Badawcza
  • Poznan, Poland, 60-369
    • Centrum Medyczne Grunwald
  • Poznań, Poland, 60-529
    • Solumed Centrum Medyczne
  • Szczecin, Poland
    • Laser Clinic
  • Warsaw, Poland
    • Klinika Ambroziak
  • Warsaw, Poland, 01-142
    • Clinical Research Group Sp. z o.o.
  • Warsaw, Poland, 01-496
    • Royalderm Agnieszka Nawrocka
  • Warsaw, Poland, 02-793
    • Clinical Best Solutions
  • Wrocław, Poland
    • WroMedica
  • Wrocław, Poland
    • CityClinic Przychodnia Lekarsko-Psychologiczna
  • Wrocław, Poland
    • dermMedica Sp z.o.o
• United States
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research Inc
    • Inglewood, California, United States, 90301
      • Axon Clinical Research
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, Inc.
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research Inc.
  • Florida
    • Miami, Florida, United States, 33135
      • Advance Medical Research Center
    • Tampa, Florida, United States, 33615
      • Alliance Clinical Research of Tampa
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida ,Inc.
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Allcutis Research, Llc
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
    • Waterford, Michigan, United States, 48328
      • Michigan Dermatology Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research, Llc
  • New York
    • New York, New York, United States, 10022
      • JUVA Skin & Laser Center
    • New York, New York, United States, 10075
      • Sadick Research Group LLC
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center
  • Texas
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Webster, Texas, United States, 77598
      • Tranquility Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at 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).	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response 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).	At Week 16
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	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).	At Week 16
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	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).	At Weeks 2, 4, 8, 12, and 20
Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) 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).	At Weeks 2, 4, 8, 12, and 20
Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) 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).	At Weeks 2, 4, 8, 12, 16, and 20
Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) 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).	At Weeks 2, 4, 8, 12, 16, and 20
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at 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).	Baseline and Weeks 2, 4, 8, 12, and 20
Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score 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).	Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20
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	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).	At Weeks 1, 2, 4, 8, 12, 16 and 20
Change From Baseline in Affected Body Surface Area (BSA) at 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.	Baseline and Weeks 2, 4, 8, 12, 16, and 20
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 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.	Baseline and Weeks 8, 16, and 20
Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at 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.	Baseline and Weeks 2, 4, 8, 12, 16, and 20
Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at 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."	Baseline and Weeks 2, 4, 8, 12, 16, and 20
Change From Baseline in Patient Global Impression of Change (PGIC) Score at 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."	Baseline and Weeks 2, 4, 8, 12, 16, and 20
Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at 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.	Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at 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.	Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20
Number of Participants With Treatment Emergent Adverse Events (TEAE)	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.	From Baseline through Week 20
Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 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.	At Week 16
Change From Baseline in Body Temperature at Weeks 16 and 20	A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Weeks 16 and 20.	Baseline and Weeks 16 and 20
Change From Baseline in Respiration Rate at Weeks 16 and 20	A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.	Baseline and Weeks 16 and 20
Change From Baseline in Heart Rate at Weeks 16 and 20	A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Weeks 16 and 20.	Baseline and Weeks 16 and 20
Change From Baseline in Systolic and Diastolic Blood Pressure at 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.	Baseline and Weeks 16 and 20
Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20	A complete physical examination that included BMI measurements was performed at screening (Visit 1) and Weeks 16 and 20.	Baseline and Weeks 16 and 20
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16	Electrocardiograms were assessed by the investigators based on automatically generated parameters.	At Week 16
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Hematocrit at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Hemoglobin at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Platelets at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Reticulocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16	Laboratory parameters including hematology was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Chemistry Parameter: Albumin at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	Baseline and Week 16
Change From Baseline in Chemistry Parameter: Phosphate at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	Baseline and Week 16
Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16	Laboratory parameters including chemistry was evaluated at baseline and at Week 16.	At Week 16
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at 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.	Baseline and Weeks 2, 4, 8, 12, 16, and 20
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)	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.	At Weeks 2, 4, 8, 12, 16, and 20

Collaborators and Investigators

• Sponsor: UNION therapeutics
• Investigators: Study Director: P. A. MD, UNION therapeutics A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Orismilast
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases
• Other Study ID Numbers: UNI50001-202; 2021-006707-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No