Phase 3
Completed N=227
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Source: ClinicalTrials.gov NCT00538434 ↗Enrolled (actual)
227
Serious AEs
2.2%
Results posted
Sep 2016
Primary outcomePrimary: Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels — -37.60; -58.27; -56.46; 11.50 percentage change in eosinophils/hpf — p=< 0.0001
◆ Published Evidence
Highly cited
551citations · ~39 / year
Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial.
Summary
This trial will study three doses of reslizumab versus placebo in children with eosinophilic esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.
Linked Publications
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Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels |
-37.60; -58.27; -56.46; 11.50 | < 0.0001 sig |
| PRIMARY Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal) |
-0.85; -1.02; -1.12; -1.14 | 0.0313 sig |
| SECONDARY Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment |
-0.94; -1.20; -1.28; -1.44 | 0.0062 sig |
| SECONDARY Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ) |
11.2; 18.6; 18.5; 11.8; 5.0; 12.2 | 0.4644 |
Eligibility Criteria
Inclusion Criteria
- written informed consent obtained
- male or female patients aged 5 to 18 years at time of screening
- of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol
- confirmed active EE (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per high power field (hpf; 400X magnification)
- within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward), abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing
- been on a therapeutic dose of proton pump inhibitors (PPIs; with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)
Exclusion Criteria
- another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome [HES],Churg Strauss vasculitis, eosinophilic gastroenteritis [EG], or a parasitic infection)
- history of abnormal gastric or duodenal biopsy or documented gastrointestinal [GI] disorders (e.g., celiac disease, Crohn's disease or Helicobacter pylori infection)
- history of the following GI surgeries: fundoplication, gastric surgery or surgery for intestinal atresia
- use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [IgE] monoclinal antibody [mAb], methotrexate, cyclosporin, interferon alpha [α], or anti tumor necrosis factor [TNF] mAb) within six months prior to study entry
- received attenuated live attenuated vaccines (e.g., measles, mumps, rubella [MMR], bacillus Calmette-Guerin [BCG], varicella, FluMist or polio) within three months prior to study entry
- use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study
- a stricture on endoscopy that prevents passage of the endoscope
- participation in any investigational drug or device study within 30 days prior to study entry
- female subjects who are pregnant or nursing
- concurrent infection or disease that may preclude assessment of EE
- concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency)
Data sourced from ClinicalTrials.gov (NCT00538434) and the linked publication. 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.