Phase 3
Completed N=190
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
Source: ClinicalTrials.gov NCT00635089 ↗Enrolled (actual)
190
Serious AEs
11.1%
Results posted
Mar 2017
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs — 177; 38; 63; 0 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434).
The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs |
177; 38; 63; 0; 21; 7 | — |
| PRIMARY Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value |
1; 1; 7; 16; 3 | — |
| PRIMARY Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality |
0; 0 | — |
| PRIMARY Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value |
21; 18; 88; 27; 42; 22 | — |
| PRIMARY Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint |
0; 7; 0; 4; 0; 1 | — |
| PRIMARY Infusion Site Evaluations |
178; 11; 1; 0; 0; 179 | — |
| PRIMARY Therapeutic Classification of Concomitant Medications in at Least 10% of Participants |
176; 93; 117; 28; 123; 83 | — |
| SECONDARY Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts |
-62.0 | — |
| SECONDARY Participant's EoE Predominant Symptoms Over Time |
— | — |
| SECONDARY Physician's EoE Global Assessment Over Time |
— | — |
| SECONDARY Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores |
4.6; 3.7; 3.1 | — |
| SECONDARY Dietary Question Responses at Endpoint |
124; 63; 21; 46 | — |
| SECONDARY Reslizumab Serum Concentrations |
15.747; 29.507; 41.360; 21.202 | — |
| SECONDARY Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent
- Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
- Did not withdraw from Study Res-05-0002 due to drug related adverse event
- Completed End of Treatment Visit for Study Res-05-0002
Exclusion Criteria
- Pregnant or nursing females
- Concurrent Immunodeficiency
- Current use of immunosuppressive drugs
- Did not tolerate study drug in Study Res-05-0002
Data sourced from ClinicalTrials.gov (NCT00635089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.