Clinical Trial: Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002

Brief 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.


Detailed Summary:

Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.


Sponsor: Ception Therapeutics

Current Primary Outcome:

  • Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs [ Time Frame: From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months) ]
    An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of study drug until 30 days after administration of the last dose of study drug were reported as treatment emergent serious adverse events.
  • Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) ]
    Hematology laboratory tests performed include: hemoglobin, hematocrit, red blood cell count, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, platelet count, white blood cell count, and differential count and percentage (polymorphonuclear leukocytes [neutrophils], lymphocytes, eosinophils, monocytes, basophils, platelets).
  • Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatme

    Original Primary Outcome: Safety profile of reslizumab [ Time Frame: approximately 4 months ]

    Current Secondary Outcome:

    • Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts [ Time Frame: Baseline, Week 16 or early withdrawal (if before Week 16) ]
      The mean change from baseline in esophageal eosinophil levels was described at week 16 or early withdrawal (if before week 16), using descriptive statistics. Baseline was defined as the last assessment before the first dose of reslizumab, which was the baseline of the double-blind study (NCT00538434) for patients who received reslizumab in the double blind study or the baseline of the open-label study for patients who received placebo during the double-blind study.
    • Participant's EoE Predominant Symptoms Over Time [ Time Frame: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) ]
      The data from the patient's/parent's eosinophilic esophagitis (EoE) Symptom Assessment were used to assess the shift from baseline in Predominant Symptom Assessment. The predominant symptom of the participant's/parent's EoE Symptom Assessment was selected at the double-blind baseline visit and remained the same throughout this study. Using the EoE Symptom Assessment, the participant/parent or legal guardian rated the severity of the previous week's EoE symptoms as none, mild, moderate, severe, or very severe on a 5-point scale. Only the predominant symptom selected for each participant contributed to the overall analysis of the Predominant Symptom Assessment and the subgroup analyses of individual symptoms. Thus, for the Predominant Symptom Analysis, some patients had dysphagia assessed, while others had either abdominal/chest pain or vomiting/regurgitation assessed.
    • Physician's EoE Global Assessment Over Time [ Time Frame: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months) ]
      The data from the participant's/parent's EoE Symptom Assessment, in combination with other observations, were used by physicians to determine the Physician's EoE Global Assessment. All components of the patient's EoE Symptom Assessment were used by physicians to determine the Physician's EoE Global Assessment.
    • Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores [ Time Frame: Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months) ]
      The Child Health Questionnaire comprises 50 items. Specific items are recoded and/or recalibrated. Raw scores for scales (domains calculated over one or more items) are then calculated following set algorithms. The raw scales are then transformed to 0 to 100 scores, except for Change in Health which remains a 1-5 score. Finally two summary measures are calculated based on weighted combinations of selected scales. The Global Health, Physical Summary Score and Psychosocial Summary Score were summarized. For each, scores range from 0 (higher disease activity) to 100 (lower disease activity); higher scores indicate better health.
    • Dietary Question Responses at Endpoint [ Time Frame: Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months) ]
      Number of participants answering that they either maintained or changed their diet from the beginning of the double-blind study (ie, NCT00538434). Additionally, for those participants who answered that they changed their diet from the beginning of the double-blind study (column 2), the number of participants in that group who changed by increasing the consistency of their food ('Increased consistency') and the percentage that changed by eating foods that previously worsened EoE ('Added foods'). (Note that these 2 categories are not mutually exclusive, so that someone could have both increased the consistency of the food they were eating AND also eaten foods that previously worsened their EoE symptoms.)
    • Reslizumab Serum Concentrations [ Time Frame: Before treatment (within 3 hours) and after treatment (within 3 hours after end of infusion) for doses at Weeks 8 and 12; within 6 days after either dose at Weeks 8 or 12; 2 to 4 weeks after dose at Weeks 8 or 12; and at premature withdrawal. ]
      Reslizumab serum concentrations obtained in this study were included in ongoing and separate population pharmacokinetic analyses. The Number of Participants Analyzed reflects the number of participants who had concentrations measured following that dose level. Since some participants started on 1 mg/kg and later increased to 2 mg/kg (and are therefore represented in more than one column), the number of participants in each column add up to a greater number than the total in the overall column, which reflects the total number of participants with measurable concentration data in this study. The number of concentrations summarized for that dose level represents more than one concentration per participant in most cases.
    • Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA) [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) ]
      Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positiv

      Original Secondary Outcome: profile of durability of response to treatment [ Time Frame: approximately 4 months ]

      Information By: Teva Pharmaceutical Industries

      Dates:
      Date Received: March 6, 2008
      Date Started: July 2008
      Date Completion:
      Last Updated: February 2, 2017
      Last Verified: February 2017