Trial · NCT05372653
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
NCT05372653, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2025-03-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis. Trials, record NCT05372653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05372653
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
- NCT number
- NCT05372653
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Atopic Dermatitis (AD)
- Interventions
- OPA-15406
- First posted
- 2022-05-13
- Last updated
- 2025-03-30
- Results first posted
- 2025-03-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | Week 4 | The investigator or sub investigator assessed the skin symptoms using IGA (Investigator's Global Assessment). The investigator or sub investigator 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 4. Incidence of success in IGA was defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and had improved by at least 2 grades (responders) from baseline. |
| Secondary | Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | Week4 | Response (improvement) in EASI 75 was defined as a decrease by ≥75% in the percent change from baseline in the total score of EASI. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | Week 4 | The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once. | Percentage of perticipants | NUMBER |
| SECONDARY | Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | Week4 | The efficacy analysis set (FAS \[full analysis set\]) consisted of all subjects who received the IMP at least once. | Percentage of perticipants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate in IGA (Percentage of Subjects With an IGA Score of 0 or 1 With Improvement by at Least 2 Grades) | 0.3% OPA-15406 | 56.10 | 95% Confidence Interval 39.75 to 71.53 | Percentage of perticipants | |
| Response Rate in Eczema Area and Severity Index (EASI) 75 (Improvement of ≥75% in EASI) | 0.3% OPA-15406 | 82.93 | 95% Confidence Interval 67.94 to 92.85 | Percentage of perticipants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.3% OPA-15406 | 12 | |
| Overall Study | STARTED | 1% OPA-15406 | 29 | |
| Overall Study | COMPLETED | 0.3% OPA-15406 | 11 | |
| Overall Study | COMPLETED | 1% OPA-15406 | 25 | |
| Overall Study | NOT COMPLETED | 0.3% OPA-15406 | 1 | |
| Overall Study | NOT COMPLETED | 1% OPA-15406 | 4 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis allergic | Eye disorders | 0.3% OPA-15406 | 0 | 41 | |
| other | Conjunctivitis allergic | Eye disorders | 1% OPA-15406 | 2 | 29 | |
| other | Constipation | Gastrointestinal disorders | 0.3% OPA-15406 | 0 | 41 | |
| other | Constipation | Gastrointestinal disorders | 1% OPA-15406 | 4 | 29 | |
| other | Vomiting | Gastrointestinal disorders | 0.3% OPA-15406 | 0 | 41 | |
| other | Vomiting | Gastrointestinal disorders | 1% OPA-15406 | 2 | 29 | |
| other | Pyrexia | General disorders | 0.3% OPA-15406 | 0 | 41 | |
| other | Pyrexia | General disorders | 1% OPA-15406 | 3 | 29 | |
| other | Bronchitis | Infections and infestations | 0.3% OPA-15406 | 0 | 41 | |
| other | Bronchitis | Infections and infestations | 1% OPA-15406 | 3 | 29 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.3% OPA-15406 | 0 | 41 |
| Total, all-cause mortality | 1% OPA-15406 | 0 | 29 |
| Total, other adverse events | 0.3% OPA-15406 | 24 | 41 |
| Total, other adverse events | 1% OPA-15406 | 29 | 29 |
| Total, serious adverse events | 0.3% OPA-15406 | 1 | 41 |
| Total, serious adverse events | 1% OPA-15406 | 1 | 29 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0.3% OPA-15406 vs 1% OPA-15406: deaths from any cause | Trial comparisons |
| 0.3% OPA-15406 vs 1% OPA-15406: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05372653
GET https://conductscience.org/api/trials/v1/NCT05372653/events?page=2