Trial · NCT05667623
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success rate in Investigator's Global Assessment at Week 4 | 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. |
| Secondary | Change from baseline in Investigator's Global Assessment at Week 4 | 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 change from baseline in Investigator's Global Assessment at Week 4. |
| Secondary | Success rate in Eczema Area and Severity Index 75 (improvement of ≥75% in Eczema Area and Severity Index) and at Week 4 | 4 weeks | 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. |
| Secondary | Eczema Area and Severity Index 90 (improvement of ≥90% in Eczema Area and Severity Index) at week 4 | 4 weeks | 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. |
| Secondary | Eczema Area and Severity Index 50 (improvement of ≥50% in Eczema Area and Severity Index) at week 4 | 4 weeks | 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. |
| Secondary | Change from baseline in the total score of Eczema Area and Severity Index and each clinical sign score at Week 4 | 4 weeks | 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. |
| Secondary | Change from baseline in Verbal Rating Scale for Pruritus at Week 4 | 4 weeks | 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 |
| Secondary | Change from baseline in Verbal Rating Scale for pruritus up to Day 7 | 7 Days | 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. |
| Secondary | Change from baseline in the total score of Patient-Oriented Eczema Measure at Week 4 | 4 weeks | 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 |
| Secondary | Change from baseline in the total score of Dermatology Life Quality Index at week 4 | 4 weeks | 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. |
| Secondary | Change from baseline in the total affected Body Surface Area (percent) at Week 4 | 4 weeks | The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 4. |
| Secondary | Success rate in Investigator's Global Assessment at Week 24 | 24 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. |
| Secondary | Time to IGA response | 24 weeks | How long the subject's Investigator's Global Assessment score (IGA score of 0 or 1) improvement by at least 2 grades will take; |
| Secondary | 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) | 24 weeks | 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. |
| Secondary | Changes from baseline in IGA score | 24 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 change from baseline in Investigator's Global Assessment at Week 24. |
| Secondary | Changes from baseline in the total score of EASI and each clinical sign score | 24 weeks | 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. |
| Secondary | Changes from baseline in the total score of Patient-Orientaed Eczema Measure (POEM) | 24 weeks | 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 |
| Secondary | Changes from baseline in the total affected BSA (%) | 24 weeks | The efficacy is assessed by change from baseline in the total affected Body Surface Area (percent) at Week 24. |
| Other | Adverse events | 4 weeks/24 weeks | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment. |
| Other | Plasma concentrations of OPA-15406 | Week 4 | prior to IMP administration and 2 hours, 4 hours, and 8 hours postdose at Week 4(only in China) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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