Topical IN-115314 Ointment in mild to moderate atopic dermatitis
Official title: 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
Run by HK inno.N Corporation · NCT07073677 · Data updated 2026-11-12
This study tests whether IN-115314 ointment (1% or 3%) works and is safe in adults with mild to moderate atopic dermatitis compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | HK inno.N Corporation Industry-sponsored |
| Drugs / interventions | dupilumab, chemotherapy, radiation |
| Locations | 1 site (Ansan, ALL) |
| Status | Recruiting |
| Started | August 12, 2025 |
| Main results expected | July 13, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07073677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 19 years and older with mild to moderate atopic dermatitis (EASI scores 0–22, IGA 2–3) and a history of stable disease for at least one month.
✕Probably not a fit
Patients with more severe disease, other significant skin conditions, or not meeting the EASI/IGA criteria may not benefit from this ointment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial evaluates the efficacy and safety of IN-115314 ointment applied twice daily for adults with mild to moderate atopic dermatitis. Participants are randomized to receive 1% or 3% IN-115314 ointment or placebo over multiple dosing periods. Primary goals are to determine eczema improvement versus placebo, with secondary aims including safety and pharmacokinetics. Eligibility requires adults aged 19 or older with a Hanifin and Rajka-confirmed atopic dermatitis, mild to moderate disease (EASI scores 0–22) and IGA 2–3, and a history of stable disease for at least one month. Exclusion criteria include other significant skin disorders. The study is sponsored by HK inno.N Corporation and conducted at Korea University Ansan Hospital in Ansan, Korea.
Why it matters
Potential benefit: If successful, participants could experience improved skin condition and relief from eczema symptoms with a safe, targeted topical treatment.
How similar studies have gone: Previous topical programs for atopic dermatitis have shown benefit in similar patient populations, though this exact 1%/3% IN-115314 formulation is novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult volunteers aged 19 or older when the informed consent is obtained. 2. Confirmed diagnosis of AD according the criteria of Hanifin and Rajka (1980). 3. AD lesions that can be applied by investigational product 4. 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: 1. 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) 2. 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) 3. 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.) 4. 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) 5. Subjects who have taken systemic anti-inflammatory for chronic or acute inflammatory disease within 2 weeks prior to the expected initial application date 6. 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.) 7. 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 8. Subjects who have clinically significant findings on 12-lead ECG at screening 9. 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. 10. Subjects who have uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) 11. Subjects who have history of drug or alcohol abuse in 56 weeks at screening 12. 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. 13. Subjects who have participated in other clinical trials within 4 weeks prior to the expected initial application date 14. Subjects who have scheduled surgery requiring hospitalization or requires surgical treatment over the clinical trial 15. 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. 16. Pregnant or lactating woman 17. Naive in atopic dermatitis treatment 18. Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
Where it's running
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Korea university Ansan hospital
Ansan, All, South Korea Recruiting
Study contacts
- Principal investigator: Son Sang Wook — Korea University Ansan Hospital
- Study coordinator: Haerim Jang
- Email: haerim.jang@inno-n.com
- Phone: +82- 31-5176-4659
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.