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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Open-Label Reslizumab	Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly

Participant Flow:   Overall Study

	Open-Label Reslizumab
STARTED	190
Completed >/= 16 Weeks of Study	181
COMPLETED	112 [1]
NOT COMPLETED	78
Adverse Event	7
Lack of Efficacy	28
Protocol Deviation	4
Lost to Follow-up	8
Not Specified	31

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Open-Label Reslizumab	Open-label reslizumab IV infusion at an initial dose of 1 mg/kg monthly

Baseline Measures

	Open-Label Reslizumab
Overall Participants Analyzed  [Units: Participants]	190
Age  [Units: Years] Mean (Standard Deviation)	12.1  (3.97)
Age, Customized  [Units: Participants]
5 to 11 years	81
12 to 19 years	109
Sex: Female, Male  [Units: Participants] Count of Participants
Female	42  22.1%
Male	148  77.9%

1.  Primary:

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) ]

2.  Primary:

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) ]

3.  Primary:

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 treatment was 30.0 [5.89] months) ]

4.  Primary:

Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value   [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) ]

5.  Primary:

Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint   [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) ]

6.  Primary:

Infusion Site Evaluations   [ Time Frame: Day 0, Weeks 4, 8, 12, 16, endpoint (last visit), any time during study (mean [SD] duration of treatment was 30.0 [5.89] months) ]

7.  Primary:

Therapeutic Classification of Concomitant Medications in at Least 10% of Participants   [ Time Frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months) ]

8.  Secondary:

Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts   [ Time Frame: Baseline, Week 16 or early withdrawal (if before Week 16) ]

9.  Secondary:

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) ]

10.  Secondary:

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) ]

11.  Secondary:

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) ]

12.  Secondary:

Dietary Question Responses at Endpoint   [ Time Frame: Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months) ]

13.  Secondary:

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. ]

14.  Secondary:

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) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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