Atopic Dermatitis (AD)Phase 3NCT05667623
To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD
A Phase 3 study testing 1% OPA-15406 Ointment in people with Atopic Dermatitis (AD), run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- 1% OPA-15406 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 29 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalization status: Outpatient.
- Age: 15 to 70 years old, inclusive (at time of obtaining informed consent), either male or female (only for 4 weeks double blind treatment).
- Able to provide written informed consent. For subjects under 18 years old (Korea: 19 years old), written informed consent must be obtained from both the subject and the subject's legal guardian.
- Diagnosis of AD based on the criteria of Hanifin and Rajka. (See Appendix 1).
- History of AD for at least 3 years.
- Atopic dermatitis affecting ≥5% to ≤40% of BSA (excluding scalp) at the screening and baseline visit (only for 4 weeks double blind treatment).
- IGA score of 2 or 3 at the screening and baseline visit (only for 4 weeks double blind treatment).
Who cannot join
- Subjects who are pregnant, possibly pregnant, or breastfeeding, who desire to become pregnant or to have their partner become pregnant during the trial period and up until 30 days after the final administration of IMP, or who are unable to either remain abstinent or employ at least two of the specified birth control methods (vasectomy, tubal ligation, vaginal diaphragm, intrauterine device [IUD], birth control pill, condom with spermicide, etc.) during the trial period and up until 30 days after the final administration of IMP.
- Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
- Subjects who have a concurrent or history of skin disease other than AD (e.g., acne, psoriasis, etc.) and who are judged inappropriate for assessment of AD in the present trial.
- Subjects who have an active viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox) or clinical signs of such infection.
- Subjects with a current or history of malignancy within the previous 5 years.
- Subjects with a current or history of recurrent bacterial infection resulting in hospitalization or requiring intravenous antibiotic treatment within the past 2 years.
Show all 41Show fewer
- Subjects with a clinically significant complication or history of any of the following disorders that the investigator judges would prevent safe conduct of the trial or impact efficacy assessment of the IMP:
- Cardiac disease (e.g., rheumatic fever or heart valve replacement).
- Endocrinologic disease (e.g., severe or uncontrolled diabetes).
- Pulmonary disease.
- Neurologic disease.
- Psychiatric disease.
- Hepatic disease (e.g., carriers of hepatitis B, hepatitis C, etc.).
- Renal disease.
- Hematologic disease.
- Immunologic or immunocompromised disease (e.g., acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome, carriers of human immunodeficiency virus [HIV] antibodies, etc.).
- Other major disease (e.g., systemic fungal infection) or other severe uncontrolled condition (e.g., drug or alcohol abuse) judged by the investigator to pose a health risk to the subject or to have the potential to impact efficacy assessment of the IMP.
- Subjects with any of the following hematology or serum chemistry results at screening visit:
- White blood cell count: ≤3, 000/µL (3 ×109/L) or >14, 000/µL (14 ×109/L).
- Platelets: ≤100, 000/µL (100 ×109/L).
- Hemoglobin: <9 g/dL (90 g/L).
- Serum creatinine: ≥2 mg/dL (176.8 μmol/L).
- Aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase [GOT]): >2 × ULN.
- Alanine aminotransferase (ALT) (glutamic pyruvic transaminase [GPT]): >2× ULN.
- Total bilirubin: ≥2.0 mg/dL (34.2 μmol/L).
- Any other abnormal laboratory test result that the investigator judges to be a clinically significant abnormality.
- Subjects who are judged by the investigator to have a clinically significant abnormal blood pressure or pulse rate at the screening and baseline visits.
- Subjects who are unable to stop allergen immunotherapy (or desensitization therapy) from 3 months prior to providing informed consent until the Week 4 visit (or at the time of withdrawal visit).
- Subjects who are unable to stop treatment with ultraviolet A, narrowband ultraviolet B, and ultraviolet B from 28 days prior to the baseline examination until the Week 4 visit/ 24 weeks (long-term administration).
- Subjects who are unable to stop using systemic corticosteroids, systemic immunosuppressant's, systemic antimetabolites, systemic retinoid, and biologics from 28 days prior to the baseline visit until the Week 4 visit/ 24 weeks (long-term administration).
- Subjects who are unable to stop using topical corticosteroids for skin (excluding scalp) categorized as very strong potency in Appendix 2 'Rank of Topical Corticosteroids' from 21 days prior to the baseline visit until the Week 4 visit/ 24 weeks (long-term administration).
- Subjects who are unable to stop using topical corticosteroids for skin (excluding scalp) categorized as strong potency in Appendix 2 'Rank of Topical Corticosteroids', topical corticosteroids other than those for skin, topical immunosuppressant's, topical retinoid, topical antihistamine and topical non-steroidal anti-inflammatory drugs (excluding for scalp) from 7 days prior to the baseline visit until the Week 4 visit/ 24 weeks (long-term administration). However, intra-ocular, intra-nasal, intra-auricular, and inhaled corticosteroids may be considered if the investigator judges that their use will not impact assessment of the affected area.
- Subjects who are unable to stop using topical corticosteroids for skin (excluding scalp) categorized as low or medium potency in Appendix 2 'Rank of Topical Corticosteroids' from 4 days prior to the baseline visit until the Week 4 visit/ 24 weeks (long-term administration).
- Subjects who are unable to continue in the trial without changing the dosage and administration of systemic antihistamines, sodium cromogicate, tranilast, or suplatast tosilate from 7 days prior to the baseline visit until the Week 4 visit/ 24 weeks (long-term administration).
- Subjects with known hypersensitivity (including history) to any drugs (prescription, OTC, etc.) or any ingredient of OPA-15406 ointment (e.g., white petrolatum, mineral oil, paraffin, white wax, or propylene carbonate).
- Subjects with known plans to receive any of the prohibited concomitant drugs or therapies during the trial period.
- Subjects who have participated in previous trials for OPA-15406 and have been administered the IMP (only for 4 weeks double blind treatment).
- Subjects who have used any other investigational drug within 4 months prior to the baseline visit or who are scheduled to participate in any other clinical trial during the trial period.
- Subjects who have never been treated with medication for AD or who are satisfied with their current AD treatment regimen.
- Subjects who do not respond at all to treatment with existing topical drugs for AD.
- Subjects who are judged by the investigator to be inappropriate to participate in the trial for any other reason.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multinational, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis
This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.
Read the detailed description
- Screening period After obtaining informed consent, the investigator will perform a screening examination. The screening period is defined as the period between the day of obtaining informed consent and the day of baseline visit (0 - 30 days).
- Assessment period (4 weeks double blind treatment period) The assessment period is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). The subject who meets the inclusion criteria and does not meet the exclusion criteria at the baseline visit will be allocated to the 1% formulation of OPA-15406 or the comparator (vehicle [placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, the examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of Week 4 visit, a withdrawal visit will be performed for that subject.
- 4 Weeks Double Blind The trial period for individual subject is the period from the day of obtaining the subject's written informed consent to the day of the Week 4 visit or withdrawal visit. For subjects who missed the Week 4 visit or withdrawal visit, the day of discontinuation will be the day when the investigator determined that the subject was to be withdrawn from the trial. It does not include the follow-up period for AE.To evaluate the efficacy (secondary endpoint) and safety of IMP (1% OPA-15406 ointment) when administered twice-daily for 4 weeks in adult patients with AD.
- 24 Weeks Open label, long term treatment period (China only) To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 1% OPA-15406 open treatment for up to 24 weeks based on the informed consent of the subjects.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- 1% OPA-15406 Ointment, 0% OPA-15406 Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% OPA-15406 OintmentDrug
Also called 0% OPA-15406 Vehicle
Twice-daily administration for 4 weeks/24 weeks.
0% OPA-15406 VehicleOther
Twice-daily administration for 4 weeks/24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1% OPA-15406 Ointment | Experimental | The 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks/24 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. Receives: Drug: 1% OPA-15406 Ointment |
| 0% OPA-15406 Vehicle | Placebo comparator | The vehicle of OPA-15406 vehicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks/24 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. Receives: Other: 0% OPA-15406 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in Investigator's Global Assessment at Week 4
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades. Subjects with missing Investigator's Global Assessment data will be handled as non-responders.
Measured: 4 weeks
Secondary outcomes (17)
Change from baseline in Investigator's Global Assessment at Week 4
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the change from baseline in Investigator's Global Assessment at Week 4.
Measured: 4 weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) at Week 4.
Measured: 4 weeks
Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) and at Week 4.
Measured: 4 weeks
Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) at week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by success rate in Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) and at Week 4.
Measured: 4 weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4.
Measured: 4 weeks
Change from baseline in Verbal Rating Scale for Pruritus at Week 4
The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in Verbal Rating Scale (VRS) for Pruritus at Week 4
Measured: 4 weeks
Change from baseline in Verbal Rating Scale for pruritus up to Day 7
The Verbal Rating Scale measures the intense pruritus in the past 24 hours following Verbal Rating Scale criteria( 0: None,1: Mild, 2: Moderate, 3: Severe). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's/subjects' judgment.
The efficacy is assessed by Change from baseline in Verbal Rating Scale for Pruritus up to day 7.
Measured: 7 Days
Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Measured: 4 weeks
Change from baseline in the total score of Dermatology Life Quality Index at week 4
The effects of symptoms on daily life will be evaluated according to Dermatology Life Quality Index (.The subjects will answer a total of 10 questions and describe the effects of the symptoms on their daily life (scale: symptoms, emotions, and functioning). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by change from baseline in the total score of Dermatology Life Quality Index at week 4.
Measured: 4 weeks
Change from baseline in the total affected Body Surface Area (percent) at Week 4
The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 4.
Measured: 4 weeks
Success rate in Investigator's Global Assessment at Week 24
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades. Subjects with missing Investigator's Global Assessment data will be handled as non-responders.
Measured: 24 weeks
Time to IGA response
How long the subject's Investigator's Global Assessment score (IGA score of 0 or 1) improvement by at least 2 grades will take;
Measured: 24 weeks
Success rate in EASI 75 (improvement of≥ 75% in EASI), EASI 90 (improvement of≥ 90% in EASI) and EASI 50 (improvement of≥ 50% in EASI)
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) , Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index), Eczema Area and Severity Index 500 (improvement of ≥50% in Eczema Area and Severity Index) at Week 24.
Measured: 24 weeks
Changes from baseline in IGA score
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by the change from baseline in Investigator's Global Assessment at Week 24.
Measured: 24 weeks
Changes from baseline in the total score of EASI and each clinical sign score
Eczema Area and Severity Index measures the severity of skin symptoms. The maximum Eczema Area and Severity Index score is 72 points. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 24.
Measured: 24 weeks
Changes from baseline in the total score of Patient-Orientaed Eczema Measure (POEM)
Eczema will be evaluated according to Patient-Oriented Eczema Measure .The subjects will answer 7 questions and describe their eczema. The investigator will confirm their responses and record the results in the source document and CRF. The total score of POEM is 28 points at the most. A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment.
The efficacy is assessed by Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 24
Measured: 24 weeks
Changes from baseline in the total affected BSA (%)
The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start6 Feb 2023
- Primary completion17 Jun 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, PHD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667623
- Sponsor's protocol ID
- 271-403-00014
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2022
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05667623
- Acronym / sponsor ID
- 271-403-00014
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.
Detailed description
- Screening period After obtaining informed consent, the investigator will perform a screening examination. The screening period is defined as the period between the day of obtaining informed consent and the day of baseline visit (0 - 30 days).
- Assessment period (4 weeks double blind treatment period) The assessment period is defined as the period between the day of baseline visit and the end of Week 4 visit (or the end of withdrawal visit). The subject who meets the inclusion criteria and does not meet the exclusion criteria at the baseline visit will be allocated to the 1% formulation of OPA-15406 or the comparator (vehicle [placebo]). The allocated IMP will be administered to the treatment area from the day of baseline visit twice-daily for 4 weeks. After the baseline visit, the examinations will be performed at Weeks 1, 2, and 4. If a subject discontinues the IMP administration between the day of baseline visit and the day of Week 4 visit, a withdrawal visit will be performed for that subject.
- 4 Weeks Double Blind The trial period for individual subject is the period from the day of obtaining the subject's written informed consent to the day of the Week 4 visit or withdrawal visit. For subjects who missed the Week 4 visit or withdrawal visit, the day of discontinuation will be the day when the investigator determined that the subject was to be withdrawn from the trial. It does not include the follow-up period for AE.To evaluate the efficacy (secondary endpoint) and safety of IMP (1% OPA-15406 ointment) when administered twice-daily for 4 weeks in adult patients with AD.
- 24 Weeks Open label, long term treatment period (China only) To be eligible for long term treatment, subjects must complete the randomized, double-blind treatment. Subjects must be judged by their investigators to have the potential for clinical benefit by longer-term exposure to OPA-15406, they can continue to receive 1% OPA-15406 open treatment for up to 24 weeks based on the informed consent of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% OPA-15406 Ointment | Experimental | Drug: 1% OPA-15406 OintmentThe 1% formulation of OPA-15406 ointment will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks/24 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
| 0% OPA-15406 Vehicle | Placebo comparator | Other: 0% OPA-15406 VehicleThe vehicle of OPA-15406 vehicle will be administered twice-daily (approximately 12 hours apart between morning and night administration) for 4 weeks/24 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalization status: Outpatient.
- Age: 15 to 70 years old, inclusive (at time of obtaining informed consent), either male or female (only for 4 weeks double blind treatment).
- Able to provide written informed consent. For subjects under 18 years old (Korea: 19 years old), written informed consent must be obtained from both the subject and the subject's legal guardian.
- Diagnosis of AD based on the criteria of Hanifin and Rajka. (See Appendix 1).
- History of AD for at least 3 years.
Key exclusion criteria (41 listed)
- Subjects who are pregnant, possibly pregnant, or breastfeeding, who desire to become pregnant or to have their partner become pregnant during the trial period and up until 30 days after the final administration of IMP, or who are unable to either remain abstinent or employ at least two of the specified birth control methods (vasectomy, tubal ligation, vaginal diaphragm, intrauterine device [IUD], birth control pill, condom with spermicide, etc.) during the trial period and up until 30 days after the final administration of IMP.
- Subjects who defined as AD or contact dermatitis rapid deterioration, within 28 days prior to the baseline visit.
- Subjects who have a concurrent or history of skin disease other than AD (e.g., acne, psoriasis, etc.) and who are judged inappropriate for assessment of AD in the present trial.
- Subjects who have an active viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox) or clinical signs of such infection.
- Subjects with a current or history of malignancy within the previous 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% OPA-15406 OintmentAlso: 0% OPA-15406 VehicleTwice-daily administration for 4 weeks/24 weeks. | Drug | 1% OPA-15406 Ointment |
| 0% OPA-15406 VehicleTwice-daily administration for 4 weeks/24 weeks. | Other | 0% OPA-15406 Vehicle |
Primary outcome
Success rate in Investigator's Global Assessment at Week 4
Time frame: 4 weeks
Investigator's Global Assessment measures the severity of atopic dermatitis (0 = Clear; 1 = Almost clear; 2 = Mild disease; 3 = Moderate disease; 4 = Severe disease/Very severe disease) of clinical characteristics (erythema, infiltration, papulation, oozing, and crusting). A higher score represents a severer clinical impression on the patient's severity based on investigator/clinician's judgment. The efficacy is assessed by the percentage of subjects with Investigator's Global Assessment score of 0 or 1 with improvement by at least 2 grades. Subjects with missing Investigator's Global Assessment data will be handled as non-responders.
17 secondary outcomes
Change from baseline in Investigator's Global Assessment at Week 4
Time frame: 4 weeks
Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4
Time frame: 4 weeks
Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4
Time frame: 4 weeks
Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) at week 4
Time frame: 4 weeks
Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4
Time frame: 4 weeks
Change from baseline in Verbal Rating Scale for Pruritus at Week 4
Time frame: 4 weeks
Change from baseline in Verbal Rating Scale for pruritus up to Day 7
Time frame: 7 Days
Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4
Time frame: 4 weeks
Change from baseline in the total score of Dermatology Life Quality Index at week 4
Time frame: 4 weeks
Change from baseline in the total affected Body Surface Area (percent) at Week 4
Time frame: 4 weeks
Success rate in Investigator's Global Assessment at Week 24
Time frame: 24 weeks
Time to IGA response
Time frame: 24 weeks
Success rate in EASI 75 (improvement of≥ 75% in EASI), EASI 90 (improvement of≥ 90% in EASI) and EASI 50 (improvement of≥ 50% in EASI)
Time frame: 24 weeks
Changes from baseline in IGA score
Time frame: 24 weeks
Changes from baseline in the total score of EASI and each clinical sign score
Time frame: 24 weeks
Changes from baseline in the total score of Patient-Orientaed Eczema Measure (POEM)
Time frame: 24 weeks
Changes from baseline in the total affected BSA (%)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianzhong Zhang, PHD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% OPA-15406 Ointment in people with Atopic Dermatitis (AD), run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate in Investigator's Global Assessment at Week 4 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.