Moderate to Severe Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
UNION therapeutics A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: The secondary objectives are to evaluate the dose response of orismilast and identify the dose to be further evaluated in a Phase 3 program.;Primary 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.;Timepoint(s) of evaluation of this end point: As defined in assessment schedule in the Protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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.;Timepoint(s) of evaluation of this end point: As defined in assessment schedule in the Protocol | — |
Countries
Germany, Hungary, Poland, United States
Contacts
Public ContactCharlotte Ørsted Pedersen
UNION therapeutics A/S
Outcome results
None listed