Mild/Moderate Atopic Dermatitis (AD) MedDRA version: 17.1 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1 Level: HLGT Classification code 10014982 Term: Epidermal and dermal conditions System Organ Class: 10040785
Conditions
Interventions
Product Name: OPA-15406 0.3% w/w
Product Code: OPA-15406 0.3% w/w
Pharmaceutical Form: Ointment
INN or Proposed INN: OPA-15406
Other descriptive name: OPA-15406
Concentration unit: % (W/W) percent wei
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The ability to provide written informed consent by parent/guardian or a legal representative (as required by local regulations) prior to the commencement of study procedures, and the ability to comply with all study requirements as assessed by the principal investigator. Additionally, a patient must provide informed consent during the screening and be able to understand that he/she may withdraw from the study at any time. All procedures for obtaining informed consent must comply with the legal requirements of an independent review board/ independent bioethics committee (IRB/IEC) of the site and local regulations. The inclusion of minors requires that parents or guardians of a minor participant are given information and provide written informed consent. If a patient participating in the study will have become 18 years (or the age of majority as specified by local laws and regulations) within 4 weeks prior to entering study 271 12-205 or in the course of the study, the informed consent should be obtained from him/her. 2.Men and women aged 10 to 70 years (inclusive). 3.Diagnosis of atopic dermatitis based on the Hanifin and Rajka criteria 4.History of atopic dermatitis for at least 3 years and/or documented diagnosis of atopic dermatitis by the investigator during the screening visit, if the patient has provided information on the 3-year history of the condition. 5.Atopic dermatitis covering = 5% to = 40% of the patient's total body surface area (BSA), except for face, neck and head, during the screening visit and the initial visit. 6.Score on the IGA disease severity scale of 2 (light) or 3 (moderate) in selected therapeutic areas during the screening visit and initial visit. 7.At least 1 measurable and assessable target change with the IGA score of 2 (light) or 3 (moderate). 8.Willingness to have photos taken of selected target changes in the course of the study. 9.Positive, though insufficient, response (previously documented or reported by the patient during a detailed screening interview), as assessed by the investigator, to at least one course of standard therapy, including: Topical steroids, UVA radiation, narrow-band UVB radiation, and UVB radiation or current inability to administer effective prior treatment. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1.Women during pregnancy or breastfeeding 2.Sexually active men and women of reproductive age who do not use dual contraceptive method or sexual abstinence at the time of the study and for 8 weeks after the last dose of the investigational medicinal product (IMP). 3.Recurrence of contact or atopic dermatitis within 28 days before the initial visit (Day 1), defined as a sudden intensification of atopic dermatitis. 4.History of concomitant conditions or other diseases (e.g., acne, psoriasis etc.) of significant intensity in selected therapeutic areas that may impact assessments performed for the study. 5.Active acute viral skin infection (e.g., herpes, zoster, varicella) and/or atopic dermatitis with clinical infection. 6.History of malignant tumor or malignant tumor within the last 5 years (except for treated (i.e. cured) basal cell carcinoma or squamous cell skin cancer). 7.History of recurrent bacterial infection defined as 3 large infections leading to hospitalization and/or requiring intravenous antibiotic therapy in the last 2 years. 8.Clinically significant history or test results 9.Results of laboratory tests: •Number of white blood cells =3,000/µl and >14,000/µl (1.5 x GGN •Alanine transaminase >1.5 x GGN •Total bilirubin = 2.0 mg/dL •or any other abnormal and, in the opinion of the investigator, clinically relevant, laboratory result 10.Clinically relevant results of 12-lead electrocardiogram (ECG), such as: AV block, elongation of the QRS complex greater than 120 ms or QTcF interval =450 ms. 11.Clinically relevant blood pressure or heart rate results, such as: •Age 18-70 years (inclusive): Systolic blood pressure in the seated position (=3 minutes) 100 beats/min. •Age =17 years (inclusive): Systolic blood pressure in the seated position (=3 minutes) 100 beats/min. 12.Use of systemic immunosuppressants/immunomodulators, corticosteroids, antimetabolites or retinoids within 28 days before the initial visit (Day 1) or plans to use them during the study. Intraocular, intranasal or inhalant corticosteroids may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas. 13.Use of local immunomodulators, group I -VII WHO classification corticosteroids, or retinoids on the body (i.e. below the neck) within 7 days before the initial visit (Day 1) or plans to use them during the study. Local application of weak corticosteroids may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas. 14.Phototherapy (UVA, narrow-band UVB radiation, and UVB radiation) within 28 days of the initial visit (Day 1) or reluctance to reduce exposure to sun rays, avoid sunbathing, tanning salons, and ultraviolet radiation therapy at the time of the study. 15.Use of systemic or local antihistamines within 7 days before the initial visit (Day 1) or plans to use them during the study. Intraocular, intranasal or inhalant antihistamines may be considered if, in the opinion of the investigator, their use does not affect assessment of the therapeutic area or areas. 16.Use of any systemic or local study medic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To evaluate the efficacy of 2 concentrations of OPA-15406 ointment (0.3% weight to weight [w/w] and 1% w/w) compared to vehicle, when administered topically twice daily (BID) in subjects with mild to moderate AD. ;Secondary Objective: Secondary Objective: To evaluate the safety and tolerability of 2 concentrations of OPA-15406 ointment compared to vehicle, when administered topically BID in subjects with mild to moderate AD. Additional Objectives: to evaluate in subjects with mild to moderate AD following 4 and 8 weeks of treatment with OPA-15406 ointment or vehicle - the overall patient reported outcomes of 2 concentrations of OPA-15406 ointment compared to vehicle, - the pharmacokinetics (PK) for 2 concentrations of OPA-15406 ointment and its metabolites - serum levels of thymus and activationregulated chemokine (TARC)/Chemokine (C-C motif) ligand 17 (CCL17).;Primary end point(s): Primary Outcome Variables: - Incidence of success (as defined by a score of 0 [clear] or 1 [almost clear] with at least a 2-grade reduction from Baseline) in the Overall IGA score at Week 4 for OPA-15406 concentrations vs. vehicle.;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Outcome Variables: - Change from baseline in Overall IGA score at Week 4 Protocol 271-12-205 - Adverse events, serious adverse events, physical and dermatologic examinations, vital signs, laboratory assessments, and electrocardiograms through Week 8. Additional Outcome Variables for Overall Assessments: - Incidence of success in the Overall IGA score at Week 8 for OPA-15406 concentrations vs. vehicle. - Overall EASI score at Weeks 4 and 8. - Subject assessment of overall itch using the VAS score for pruritus at Weeks 4 and 8. - Overall % BSA affected and target lesion size at Weeks 4 and 8. - Overall subject-assessed DLQI score or CDLQI score at Weeks 4 and 8. - Levels of TARC/CCL17 at Weeks 4 and 8 Additional Outcome Variables for Target Lesion Assessments: - Incidence of success in the Target Lesion on the IGA score at Weeks 4 and 8. - Modified EASI score at Weeks 4 and 8. Additional Outcome Variables for Target Lesion Assessments: - Incidence of success in the Target Lesion on the IGA score at Weeks 4 and 8. - Modified EASI score at Weeks 4 and 8.;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of Secondary Outcome: Week 4 or respectively week 8 Timepoint(s) of evaluation of Additional Outcome Variables for Overall Assessments: Week 4 or respectively week 4 and 8 Timepoint(s) of evaluation of Additional Outcome Variables for Target Lesion Assessments: week 4 and 8 | — |
Countries
Australia, Poland, United States
Contacts
Public ContactEwa Gózdz
Associated Medical Clinical Science Services Sp. z o.o.
Outcome results
None listed