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    Summary
    EudraCT Number:2021-006707-15
    Sponsor's Protocol Code Number:UNI50001-202
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-04-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-006707-15
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy and safety of Orismilast in Atopic Dermatitis
    A.4.1Sponsor's protocol code numberUNI50001-202
    A.5.4Other Identifiers
    Name:IND numberNumber:129386
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUNION therapeutics A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUNION therapeutics A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNION therapeutics A/S
    B.5.2Functional name of contact pointCharlotte Ørsted Pedersen
    B.5.3 Address:
    B.5.3.1Street AddressTuborg Havnevej 18
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post codeDK-2900
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4553843044
    B.5.6E-mailcharlotte.oersted.pedersen@uniontherapeutics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOrismilast
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOrismilast
    D.3.9.1CAS number 1353546-86-7
    D.3.9.3Other descriptive nameLEO 32731
    D.3.9.4EV Substance CodeSUB204073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOrismilast
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOrismilast
    D.3.9.1CAS number 1353546-86-7
    D.3.9.3Other descriptive nameLEO 32731
    D.3.9.4EV Substance CodeSUB204073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Atopic Dermatitis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy and safety of a modified-release orismilast tablet versus placebo in patients aged at least 18 years with moderate to severe Atopic Dermatitis (AD).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the dose response of orismilast and identify the dose to be further evaluated in a Phase 3 program.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol
    2. Male and female patients aged at least 18 years at the time of signing the ICF
    3. Body weight of greater than 40 kg at the time of signing the ICF
    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 of 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
    7. Patients having a documented history of inadequate response to treatment with topical medications given for at least 4 weeks (at least 2 weeks for high potency topical corticosteroids), or as labeled, or for whom topical treatments are otherwise medically inadvisable.
    8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at the Screening visit and a negative urine pregnancy test result at the Baseline visit. In addition, sexually active WOCBP must agree to use a highly effective method of contraception throughout the study and until at least 4 weeks after the end of study treatment. Please refer to clinical trial protocol for more details
    E.4Principal exclusion criteria
    1.Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study: Therapy-resistant AD,defined as ≥2 treatment failures due to inadequate efficacy within the past 2 years of any biologic therapy,JAK inhibitor treatment or phototherapy administered at an adequate dose and duration according to the label or local/national guidelines.(Patients who stopped systemic treatment for reasons not related to lack of efficacy are not excluded)
    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.Currently have active forms of other inflammatory skin disease or have evidence of skin conditions (eg, psoriasis,seborrheic dermatitis,lupus) at the Baseline visit that would interfere with evaluation of AD or response to treatment
    5.Active infection (eg, bacterial,viral,fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
    6.Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
    7.Any chronic or recurrent medical condition associated with serious GI diseases, such as inflammatory bowel disease
    8.Any medical or psychiatric condition (eg, current major depression with a score for depressive symptoms ≥15 of Hospital Anxiety and Depression Scale[HADS] at baseline,schizophrenia,suicidal behavior,psychiatric hospitalization within the prior year) that, in the Investigator’s opinion,would preclude the patient from adhering to the protocol, completing the study per-protocol,and/or would place the patient at unacceptable risk while receiving the investigational therapy
    9.Individuals with severe or uncontrolled asthma or any other concomitant condition that is likely to require systemic corticosteroid bursts during the study
    10.Any therapies and systemic treatments as described in Table 3 “Nonallowed therapies and treatments” in protocol that do not comply with the indicated washout interval
    11.Any previous treatment with orismilast or failure of treatment for AD with apremilast or any other systemic PDE4 inhibitor
    12.Any condition,including laboratory or ECG abnormalities,that places the patient at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
    13.Severe hepatic impairment based upon medical history and laboratory abnormalities (eg,low albumin and abnormal bilirubin levels)
    14.Any of the following abnormalities in clinical laboratory test results at Screening,as assessed by the study-specific laboratory and confirmed by a single repeat test,if deemed necessary:
    •Absolute neutrophil count of less than the lower normal range of the Central Laboratory(LNR)i.e. 1.7×10^9/L(1700/mm^3)
    •HGB of less than 10.0g/dL or HCT less than 30%
    •PLT count of less than 100,000 mm^3
    •Absolute lymphocyte count of less than the lower normal range of the
    LNR i.e. 0.9×10^9/L(900/mm^3)
    •Total bilirubin greater than 1.5× the upper limit of
    normal(ULN);patients with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided
    the direct bilirubin result is less than or equal to the ULN
    •ALN or AST greater than 2.5×the ULN
    •Serum creatinine greater than or equal to 1.5mg/dL.For patients with
    a value of greater than or equal to 1.5mg/dL,if their creatinine clearance is at least 60mL/min(calculated using the CKD Epidemiology Collaboration creatinine equation),enrollment may be allowed
    15.History or evidence of hep. B virus infection at Screening. Patients with a positive hep. B surface antigen result are excluded. For patients with an isolated positive antihepatitis B core antibody result, the hep. B surface antibody result must also be positive to be eligible for this study
    16.History or positive test result for hep. C virus (HCV) antibody, indicating ongoing infection, at Screening. Confirmatory testing for HCV RNA will be conducted for patients who have a positive test result. Patients who have a negative result for HCV RNA will be eligible to participate in the study
    17.History of positive HIV test result or congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). Patients who are positive for HIV antibodies (HIV-1 or HIV-2) at Screening are excluded from the study.
    18.Suicidal ideation or behavior in the past 12 months as indicated by a positive response (yes) to question 4 or 5 on the C-SSRS completed at the Screening visit or at Baseline
    19.Pregnant or breastfeeding
    20.History of alcohol or substance abuse within 6 months before Baseline that, in the opinion of the Investigator, will preclude participation in the study
    21.Institutionalized by court order or by local authority
    22. Regular use (more than 2 visits per week) of a tanning booth/parlor
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the percentage change in Eczema Area and Severity Index (EASI) score from Baseline at Week 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined in assessment schedule in the Protocol
    E.5.2Secondary end point(s)
    The key secondary endpoints are as follows:
    • Patients achieving 75% reduction in EASI (EASI75) response at Week 16
    • Patients 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

    For other secondary endpoints and safety endpoints, please refer to Protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As defined in assessment schedule in the Protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Hungary
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 210
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 210
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-15
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