A Study to Evaluate the Efficacy and Safety of IN-115314 Ointment in Mild to Moderate Atopic Dermatitis Adult Patients

NCT07073677 | Not Yet Recruiting Phase 2

• 1 other identifier: IN_JSI_201
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of IN-115314 Ointment in mild to moderate atopic dermatitis adult patients

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change rate in EASI score from the baseline after treatment

  4 weeks

Secondary Outcomes (2)

• Change rate in EASI score from the baseline after treatment

  1 week, 2 weeks

• Changes in EASI score from the baseline after treatment

  1 week, 2 weeks, 4 weeks

Study Arms (3)

J1

EXPERIMENTAL

IN-115314 Ointment 1%

Drug: IN-115314 Ointment 1%

J3

EXPERIMENTAL

IN-115314 Ointment 3%

Drug: IN-115314 Ointment 3%

PJ

PLACEBO COMPARATOR

IN-115314 Ointment Placebo

Drug: IN-115314 Ointment placebo

Interventions

IN-115314 Ointment 1% DRUG

Twice daily(BID), for 56 day

J1

IN-115314 Ointment 3% DRUG

Twice daily(BID), for 56 day

J3

IN-115314 Ointment placebo DRUG

Twice daily(BID), IN-115314 Ointment Placebo for 28 days+ IN-115314 Ointment 3% for 28 days

PJ

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<
• \) 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Officials

• Son Sang Wook

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haerim Jang

CONTACT

+82- 31-5176-4659; haerim.jang@inno-n.com

Yugyeong Park

CONTACT

+82- 31-5176-4661; yugyeong.park@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share