Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
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| ClinicalTrials.gov Identifier: NCT00538434 |
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Recruitment Status :
Completed
First Posted : October 2, 2007
Results First Posted : September 2, 2016
Last Update Posted : September 2, 2016
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Sponsor:
Ception Therapeutics
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Ception Therapeutics )
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eosinophilic Esophagitis | Biological: Reslizumab Other: Saline | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 227 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | October 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eosinophilic Esophagitis
Drug Information available for:
Reslizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Reslizumab 1 mg/kg
reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
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Biological: Reslizumab
Other Names:
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Experimental: Reslizumab 2 mg/kg
reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
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Biological: Reslizumab
Other Names:
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Experimental: Reslizumab 3 mg/kg
reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
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Biological: Reslizumab
Other Names:
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Placebo Comparator: Placebo
saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
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Other: Saline |
Primary Outcome Measures :
- Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels [ Time Frame: Baseline, End of Treatment (up to 15 weeks [+/- 4 days]) ]Participants underwent esophagogastroduodenoscopy (EGD) with biopsy (2 biopsies each at proximal and distal esophageal locations, plus any inflamed or abnormal areas) per standard clinical practice for the determination of esophageal eosinophils.
- Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal) [ Time Frame: Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal) ]
The investigator completed the Physician's EE Global Assessment based upon the participant's reporting of symptoms, weight, dietary status, and overall well-being. The assessment rated severity on a five-point scale (0=none to 4=very severe), taking into account physical findings, vital signs, the Subject's Predominant EE Symptom Assessment, the subject's diary data, and dietary questions. The Subject's Predominant EE Symptom was the EE symptom (vomiting/regurgitation, abdominal/chest pain, or dysphagia) that had the greatest negative impact on the subject based on patient diary data as of the baseline visit.
The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Physician's EE Global Assessment indicate improvement in EE status.
Secondary Outcome Measures :
- Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment [ Time Frame: Baseline (Day 1, pre-treatment), End of Treatment (Week 15, 3 weeks [± 4 days] after the last dose of study drug, or at early withdrawal) ]Participants rated the severity of each EE symptom (vomiting/regurgitation, abdominal/chest pain, and dysphagia) based on the previous week's daily diary as none (=0), mild, moderate, severe, or very severe (=4). The predominant symptom was selected at the baseline visit and remained the same throughout the trial. The predominant symptom was defined as the EE symptom that had the greatest negative impact on the participant. The full range for change from baseline values is -4 (very severe at baseline, none at end of study) to 4 (none at baseline, severe at end of study). Negative change from baseline scores in the Patient's EE Predominant Symptom Assessment indicate improvement in the selected symptom.
- Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ) [ Time Frame: Baseline, End of Treatment (up to 15 weeks +/- 4 days) ]CHQ is a quality-of-life (QoL), observer-rated (the parent in this study) instrument designed to assess the general health and well-being of pediatric subjects aged 5 to 18 years. The instrument comprises 50 items that cover 14 unique physical and psychological concepts. Each item was scored separately following different scales and timeframes for response. Proprietary scoring algorithms are used. This outcome reports the two CHQ Summary Scores (Physical Summary Score and the Psychosocial Summary Scores) which are indexed to a 0 (poorest quality of life) to 100 (best quality of life) scores. The two summary scores are subsequently combined (via proprietary algorithm) to create the Global Health Summary Score (also on a 0-100 scale). Percent change from baseline values range from 100% (poorest QoL at baseline, best QoL at end of treatment) to -100% (best QoL at baseline, poorest QoL at end of treatment). Higher percent change from baseline values indicate improved QoL.
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| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538434
Locations
Show 37 study locations
Sponsors and Collaborators
Ception Therapeutics
Investigators
| Study Director: | Sponsor's Medical Expert, MD | Cephalon (Ception) |
Publications of Results:
| Responsible Party: | Ception Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00538434 |
| Other Study ID Numbers: |
Res-05-0002 |
| First Posted: | October 2, 2007 Key Record Dates |
| Results First Posted: | September 2, 2016 |
| Last Update Posted: | September 2, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc. ( Ception Therapeutics ):
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Eosinophilic Esophagitis GERD EE Reslizumab |
IL-5 Interleukin-5 Cinquil |
Additional relevant MeSH terms:
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Eosinophilic Esophagitis Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Eosinophilia Leukocyte Disorders |
Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Reslizumab Anti-Asthmatic Agents Respiratory System Agents |