A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Primary Objective
- To evaluate the efficacy of IN-115314 ointment (1%, 3%) compared to placebo after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
Secondary Objective
- To evaluate the safety of IN-115314 ointment (1%, 3%) after multiple dosing, twice a day, in mild to moderate atopic dermatitis adult patients.
- To evaluate the pharmacokinetic(PK) profile of IN-115314 ointment (1%, 3%) after multiple dosing ,twice a day, in mild to moderate atopic dermatitis adult patients.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Haerim Jang
- Phone Number: +82- 31-5176-4659
- Email: haerim.jang@inno-n.com
Study Contact Backup
- Name: Yugyeong Park
- Phone Number: +82- 31-5176-4661
- Email: yugyeong.park@inno-n.com
Study Locations
-
-
ALL
-
Ansan, ALL, South Korea, 15355
- Recruiting
- Korea University Ansan Hospital
-
Contact:
- Korea university Ansan hospital
- Phone Number: 01082795183
- Email: skin4u@korea.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult volunteers aged 19 or older when the informed consent is obtained.
- Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980).
- AD lesions that can be applied by investigational product
- AD diagnosed by EASI score of mild (EASI < 16) or moderate (16 ≤ EASI <
23) at screening. 5) Subjects who Investigator Global Assessment (IGA) of 2 to 3 at screening 6) Subjects who have a history of AD at least 12 months prior to screening and who have not improved or worsened the disease for at least one month prior to screening 7) Subjects who voluntarily decide to participate and agree to comply with the requirements
Exclusion Criteria:
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders other than AD ( e.g., psoriasis, contact dermatitis, erythroderma)
- Subjects who have the following prior/current history in addition to evidence or history of clinically significant skin disorders (e.g., hepatic, renal, Cardiovascular, respiratory, endocrine, neurological, hematological, immunological or immunodeficiency disease)
- Subjects who have a history of malignant tumors within 5 years at screening (but, those who have passed five years without recurrence after active tumor treatment (surgery, chemotherapy, radiation therapy, etc.) can participate.)
- Subjects who have clinically significant systemic or local skin infections or clinical signs of such infections within one week prior to the expeced initial application date (e.g., herpes simplex, shingles, chickenpox)
- Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date
- Subjects who have a history of clinical significant hypersensitivity reactions to Investigational product , other drugs (aspirin, penicillin antibiotics, macrolide antibiotics, etc.) and moisturizers provided by sponsor (anaphylaxis or angioedema, etc.)
Subjects who have administered the following drugs within the specified period before the expected initial application date; subjects who are expected to be administered within the clinical trial period; subjects who are unable to stop administration Biological agents that may affect signs and symptoms of AD within 12 weeks (e.g., dupilumab)
The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within 4 weeks:
- Systemic immunosuppressants/immunosuppressants
- Oral Janus kinase (JAK) inhibitor medication
- a live vaccine
- systemic retinoid
- phototherapy treatment
- Systemic corticosteroids
The following medications and treatments that may affect the signs and symptoms of atopic dermatitis within two weeks:
- a systemic anti-inflammatory drug
- systemic anti-microbial agents
- bleach treatment
The following medications that may affect the signs and symptoms of atopic dermatitis within one week:
- topical corticosteroids
- topical calcineurin inhibitor
- topical antihistamines
- a topical anti-microbial agent
- a topical PDE-4 inhibitor
- topical retinoid
- Oral antihistamines
- Subjects who have clinically significant findings on 12-lead ECG at screening
The following clinically significant findings on laboratory examination at screening
- Hb < 10 g/dL
- Platelet or ANC level < 0.5 x lower limit of normal
- AST, ALT, ALP, γ-GTP is ≥ 2 or total bilirubin level is ≥ 1.5 x upper limit of normal;
- Serum creatinine level is ≥ 2 x upper limit of normal;
- Positive anti-HCV, HBs Ag, HIV Ag/Ab, or IGRA test.
- Subjects who have uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg)
- Subjects who have history of drug or alcohol abuse in 56 weeks at screening
- Subjects who have donated whole blood or apheresis within 4 weeks prior to the expected initial application date or received blood transfusion within 4 weeks prior to the expected initial application date, or subjects who cannot continuously abstain from blood donation over a period from the informed consent to PSV.
- Subjects who have participated in other clinical trials within 4 weeks prior to the expected initial application date
- Subjects who have scheduled surgery requiring hospitalization or requires surgical treatment over the clinical trial
- Subjects or spouses (or partners) who have a plan for pregnancy or although unplanned pregnancy, are unable to use a highly effective method of contraception over a period from the informed consent to 90 days after the last dose of investigational product.
- Pregnant or lactating woman
- Naive in atopic dermatitis treatment
- Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: J1
IN-115314 Ointment 1%
|
Twice daily(BID), for 56 day
|
|
Experimental: J3
IN-115314 Ointment 3%
|
Twice daily(BID), for 56 day
|
|
Placebo Comparator: PJ
IN-115314 Ointment Placebo
|
Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time Frame: 4 weeks
|
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
|
4 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change rate in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time Frame: 1 week, 2 weeks
|
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
|
1 week, 2 weeks
|
|
Changes in EASI (Eczema Area and Severity Index) score from the baseline after treatment
Time Frame: 1 week, 2 weeks, 4 weeks
|
Eczema Area and Severity Index (EASI) score ranges from 0 to 72, Higher scores mean worse outcome.
|
1 week, 2 weeks, 4 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Son Sang Wook, Korea University Ansan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IN_JSI_201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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