Atopic DermatitisPhase 3NCT03961529
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
A Phase 3 study testing 0.3% OPA-15406 ointment and 1% OPA-15406 ointment in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- 0.3% OPA-15406 ointment and 1% OPA-15406 ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteJapan
- Study dates
- 14 May 2019to 11 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: At least 2 years (at time of obtaining informed consent)
- Diagnosis of AD based on the Japanese Dermatological Association's criteria
- Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
Who cannot join
- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- 0.3% OPA-15406 ointment, 1% OPA-15406 ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% OPA-15406 ointmentDrug
Twice daily
1% OPA-15406 ointmentDrug
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| 0.3% OPA-15406 ointment | Experimental | Twice daily Receives: Drug: 0.3% OPA-15406 ointment |
| 1% OPA-15406 ointment | Experimental | Twice daily Receives: Drug: 1% OPA-15406 ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
Measured: Treatment period (52 weeks)
Secondary outcomes (2)
Responder Rate of Investigator's Global Assessment (IGA)
The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 52.
Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline.
Measured: Week 52
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD. The investigator or sub investigator scored the severity (0-3 points) and affected body surface area (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs).
EASI 75 is defined as the rate of subjects whose EASI score has improved at least 75% from baseline.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start14 May 2019
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osamu Sato, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961529
- Sponsor's protocol ID
- 271-102-00006
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2019
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Publications
Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.
PubMed 35716332
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
- ClinicalTrials.gov ID
- NCT03961529
- Acronym / sponsor ID
- 271-102-00006
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.3% OPA-15406 ointment | Experimental | Drug: 0.3% OPA-15406 ointmentTwice daily |
| 1% OPA-15406 ointment | Experimental | Drug: 1% OPA-15406 ointmentTwice daily |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: At least 2 years (at time of obtaining informed consent)
- Diagnosis of AD based on the Japanese Dermatological Association's criteria
- Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
Key exclusion criteria (1 listed)
- Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
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 |
|---|---|---|
| 0.3% OPA-15406 ointmentTwice daily | Drug | 0.3% OPA-15406 ointment |
| 1% OPA-15406 ointmentTwice daily | Drug | 1% OPA-15406 ointment |
Primary outcome
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: Treatment period (52 weeks)
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
2 secondary outcomes
Responder Rate of Investigator's Global Assessment (IGA)
Time frame: Week 52
Responder Rate of Eczema Area and Severity Index 75 (EASI 75)
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35716332Saeki H, Imamura T, Yokota D, Tsubouchi H. Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. Dermatol Ther (Heidelb). 2022 Jul;12(7):1589-1601. doi: 10.1007/s13555-022-00751-9. Epub 2022 Jun 18.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
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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.
Osamu Sato study director
Otsuka Pharmaceutical Co., Ltd.
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 0.3% OPA-15406 ointment and 1% OPA-15406 ointment in people with Atopic Dermatitis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 3 inclusion and 1 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 19 Nov 2021. 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 Japan. 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. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: Treatment period (52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03961529, which also lists 1 linked publication.
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 19 Nov 2021.