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Atopic DermatitisPhase 2NCT05469464

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

A Phase 2 study testing Orismilast modified release tablets in people with Atopic Dermatitis and Skin Diseases, run by UNION therapeutics at 48 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis, Skin Diseases
What is being tested?
Orismilast modified release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
48 sitesin 4 countries
Study dates
11 Jul 2022to 15 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

48 sites in 4 countries.

48 sites in 4 countries

United States18 sites

  • ALLCUTIS Research, LLC

    Beverly, Massachusetts, 01915

  • Hope Clinical Research

    Canoga Park, California, 91303

  • First OC Dermatology Research Inc

    Fountain Valley, California, 92708

  • Clinical Trial Network

    Houston, Texas, 77074

  • Axon Clinical Research

    Inglewood, California, 90301

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • LA Universal Research Center, INC.

    Los Angeles, California, 90057

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124

  • Advance Medical Research Center

    Miami, Florida, 33135

  • Juva Skin & Laser Center

    New York, New York, 10022

  • Sadick Research Group LLC

    New York, New York, 10075

  • ALLCUTIS Research, LLC

    Portsmouth, New Hampshire, 03801

  • Acclaim Clinical Research Inc.

    San Diego, California, 92120

  • Clinical Research Trials of Florida ,Inc.

    Tampa, Florida, 33607

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

  • Tranquility Research

    Webster, Texas, 77598

Other trials in United States

Poland17 sites

  • NZOZ Specjalistyczny Orodek Dermatologiczny DERMAL

    Bialystok

  • Specjalistyczna Praktyka Lekarska Gabinet Dermatologiczny dr n.med. Edyta Gebska

    Chorzów

  • Zespol Naukowo - Leczniczy Dermatologiczne Centrum Uzdrowiskowe Iwolang Sp. z o.o.

    Iwonicz-Zdrój

  • Provita Sp. z o.o.

    Katowice

  • Centrum Medyczne All-Med

    Krakow

  • Maxxmed Centrum Zdrowia i Urody

    Lubin, 20-080

  • Klinika Badawcza

    Malbork

  • Centrum Medyczne Grunwald

    Poznan, 60-369

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Laser Clinic

    Szczecin

  • Clinical Research Group Sp. z o.o.

    Warsaw, 01-142

  • Royalderm Agnieszka Nawrocka

    Warsaw, 01-496

  • Clinical Best Solutions

    Warsaw, 02-793

  • Klinika Ambroziak

    Warsaw

  • CityClinic Przychodnia Lekarsko-Psychologiczna

    Wroclaw

  • dermMedica Sp z.o.o

    Wroclaw

  • Wromedica

    Wroclaw

Other trials in Poland

Germany9 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim

  • ISA - Interdisciplinary Study Association GmbH

    Berlin

  • Rosenpark Research GmbH

    Darmstadt

  • Hautarztpraxis Dr.Gerlach

    Dresden, Saxony, 1097

  • TFS Trial From Support GmbH

    Hamburg

  • MVZ DermaKiel GmbH

    Kiel, Schleswig-Holstein, 24148

  • Studienzentrum Dr.Beate Schwarz

    Langenau

  • Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik fuer Dermatologie und Allergologie

    Munich

  • KliFOs - Klinische Forschung Osnabrueck

    Osnabrück

Other trials in Germany

Hungary4 sites

  • Obudai Egeszsegugyi Centrum

    Budapest

  • Dermamed Research Kft

    Orosháza

  • PTE AOK

    Pécs

  • Obudai Egeszsegugyi Centrum

    Zalaegerszeg

Other trials in Hungary

About this study

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

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.

Being tested
Orismilast modified release tablets, Placebo
Keywords
Atopic Dermatitis, Orismilast
Medical subject headings
Dermatitis, Atopic, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orismilast modified release tabletsDrug

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

    Other Names:

    • UNI50001
    • LEO32731

  • PlaceboDrug

    Placebo matching tablets

Study groups in NCT05469464
Study groupRoleWhat they receive
Orismilast modified release tablets 20 mg BIDExperimentalOral, twice daily morning and evening
Receives: Drug: Orismilast modified release tablets
Orismilast modified release tablets 30 mg BIDExperimentalOral, twice daily morning and evening
Receives: Drug: Orismilast modified release tablets
Orismilast modified release tablets 40 mg BIDExperimentalOral, twice daily morning and evening
Receives: Drug: Orismilast modified release tablets
Placebo tablets BIDPlacebo comparatorOral, twice daily morning and evening
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and Week 16

Secondary outcomes (45)

  1. 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).

    Measured: At Week 16

  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

    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).

    Measured: At Week 16

  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

    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).

    Measured: At Weeks 2, 4, 8, 12, and 20

  4. 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).

    Measured: At Weeks 2, 4, 8, 12, and 20

  5. 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).

    Measured: At Weeks 2, 4, 8, 12, 16, and 20

  6. 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).

    Measured: At Weeks 2, 4, 8, 12, 16, and 20

  7. 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).

    Measured: Baseline and Weeks 2, 4, 8, 12, and 20

  8. 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).

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

  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

    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).

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

  10. 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.

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20

  11. 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.

    Measured: Baseline and Weeks 8, 16, and 20

  12. 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.

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20

  13. 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."

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20

  14. 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."

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20

  15. 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.

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

  16. 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.

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

  17. 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.

    Measured: From Baseline through Week 20

  18. 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.

    Measured: At Week 16

  19. 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.

    Measured: Baseline and Weeks 16 and 20

  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.

    Measured: Baseline and Weeks 16 and 20

  21. 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.

    Measured: Baseline and Weeks 16 and 20

  22. 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.

    Measured: Baseline and Weeks 16 and 20

  23. 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.

    Measured: Baseline and Weeks 16 and 20

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

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

    Measured: At Week 16

  25. 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.

    Measured: Baseline and Week 16

  26. 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.

    Measured: Baseline and Week 16

  27. 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.

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

  30. 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.

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

  38. 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.

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

  40. 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.

    Measured: Baseline and Week 16

  41. 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.

    Measured: Baseline and Week 16

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

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

    Measured: Baseline and Week 16

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

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

    Measured: At Week 16

  44. 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.

    Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20

  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)

    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.

    Measured: At Weeks 2, 4, 8, 12, 16, and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start11 Jul 2022
  3. Primary completion23 Jan 2024
  4. Study completion15 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469464
Sponsor's protocol ID
UNI50001-202
Other IDs
2021-006707-15
Status last verified
Mar 2025
First submitted
18 Jul 2022
Last updated
7 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orismilast modified release tablets in people with Atopic Dermatitis and Skin Diseases, run by UNION therapeutics at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Poland, Germany, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469464.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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