Trial · NCT04543409
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of Participants | NUMBER |
| PRIMARY | Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Tissue Eosinophils | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Grade Score at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Grade Score Ratio Change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Stage Score at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Grade Score Ratio Change | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Centrally-read Endoscopic Reference Score (EREFS) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Responder Rate at Week 24, Defined as a Composite of Histological Response (≤6eos/Hpf) and Clinically Meaningful Improvement From Baseline in Dysphagia Symptom Questionnaire (DSQ) (30% Improvement) at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of Participants | NUMBER |
| SECONDARY | Centrally-read Biopsies for Additional Histopathology Including Tissue Eosinophil Counts at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dysphagia-free Days as Captured by the Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Days | MEAN |
| SECONDARY | Frequency of Dysphagia Episodes as Captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Ratio of Episodes per 28 Day period | MEAN |
| SECONDARY | Changes From Baseline in Dysphagia Associated Pain, Discomfort, and Overall Severity as Captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Scores per day | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Dysphagia Associated Pain, Discomfort, and Overall Severity as Captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) at Week 52 | Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Scores per day | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Abdominal Pain and Nausea as Captured by the Daily Diary at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Scores per day | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Abdominal Pain and Nausea as Captured by the Daily Diary at Week 52 | Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Scores per day | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in the Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | MEAN |
| SECONDARY | Changes From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A) at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A) at Week 52 | Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form 36-item Health Survey (Version 2, Acute Recall) (SF-36v2) at Week 52 | Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Patients With Relevant Concomitant Procedures and Healthcare Resource Utilization at Week 24 and Week 52. | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Participants | COUNT_OF_PARTICIPANTS |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04543409/outcomes