Trial · NCT00538434

Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

NCT00538434, Phase 2, Phase 3, Completed, Ception Therapeutics; results first posted 2016-09-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years. Trials, record NCT00538434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00538434

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
NCT number: NCT00538434
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 227 participants, actual
Lead sponsor: Ception Therapeutics
Conditions: Eosinophilic Esophagitis
Interventions: Reslizumab, Saline
First posted: 2007-10-02
Last updated: 2016-09-02
Results first posted: 2016-09-02

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	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.
Primary	Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	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	Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment	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.
Secondary	Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	Baseline, End of Treatment (up to 15 weeks [+/- 4 days])	ITT population: all randomized participants who received any amount of study drug.	percentage change in eosinophils/hpf	MEAN
PRIMARY	Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	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)	ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.	units on a scale	MEAN
SECONDARY	Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment	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)	ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment.	units on a scale	MEAN
SECONDARY	Mean Percent Change From Baseline to End of Treatment in the Child Health Questionnaire (CHQ)	Baseline, End of Treatment (up to 15 weeks +/- 4 days)	ITT population: all randomized participants who received any amount of study drug with both a baseline and an End of Treatment assessment; n=number of participants with a response in the given category.	percentage change in score	MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	Reslizumab 1 mg/kg	-37.60	Standard Deviation 70.86	percentage change in eosinophils/hpf
Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	Reslizumab 2 mg/kg	-58.27	Standard Deviation 35.45	percentage change in eosinophils/hpf
Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	Reslizumab 3 mg/kg	-56.46	Standard Deviation 34.82	percentage change in eosinophils/hpf
Mean Percent Change From Baseline to End of Treatment in Peak Esophageal Eosinophil (EE) Levels	Placebo	11.50	Standard Deviation 91.42	percentage change in eosinophils/hpf
Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	Reslizumab 1 mg/kg	-0.85	Standard Deviation NA	units on a scale
Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	Reslizumab 2 mg/kg	-1.02	Standard Deviation NA	units on a scale
Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	Reslizumab 3 mg/kg	-1.12	Standard Deviation NA	units on a scale
Mean Change From Baseline in Physician's Esophageal Eosinophil (EE) Global Assessment At The End-of-Treatment Visit (or at Early Withdrawal)	Placebo	-1.14	Standard Deviation NA	units on a scale
Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment	Reslizumab 1 mg/kg	-0.94	Standard Deviation NA	units on a scale
Mean Change From Baseline to End of Treatment in EE Predominant Symptom Assessment	Reslizumab 2 mg/kg	-1.20	Standard Deviation NA	units on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Reslizumab 1 mg/kg	56
Overall Study	STARTED	Reslizumab 2 mg/kg	57
Overall Study	STARTED	Reslizumab 3 mg/kg	57
Overall Study	STARTED	Placebo	57
Overall Study	Intent-to-treat (ITT) Population	Reslizumab 1 mg/kg	55
Overall Study	Intent-to-treat (ITT) Population	Reslizumab 2 mg/kg	57
Overall Study	Intent-to-treat (ITT) Population	Reslizumab 3 mg/kg	57
Overall Study	Intent-to-treat (ITT) Population	Placebo	57
Overall Study	COMPLETED	Reslizumab 1 mg/kg	47
Overall Study	COMPLETED	Reslizumab 2 mg/kg	46

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events140

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL PAIN	Gastrointestinal disorders	Reslizumab 1 mg/kg	6	55	7
other	ABDOMINAL PAIN	Gastrointestinal disorders	Reslizumab 2 mg/kg	0	57	0
other	ABDOMINAL PAIN	Gastrointestinal disorders	Reslizumab 3 mg/kg	3	57	3
other	ABDOMINAL PAIN	Gastrointestinal disorders	Placebo	2	57	2
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Reslizumab 1 mg/kg	4	55	4
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Reslizumab 2 mg/kg	2	57	2
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Reslizumab 3 mg/kg	4	57	5
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Placebo	5	57	8
other	DIARRHOEA	Gastrointestinal disorders	Reslizumab 1 mg/kg	4	55	4
other	DIARRHOEA	Gastrointestinal disorders	Reslizumab 2 mg/kg	3	57	3

1 to 10 of 140Source ClinicalTrials.gov

See all 140 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Reslizumab 1 mg/kg
Total, all-cause mortality	Reslizumab 2 mg/kg
Total, all-cause mortality	Reslizumab 3 mg/kg
Total, all-cause mortality	Placebo
Total, other adverse events	Reslizumab 1 mg/kg	38	55
Total, other adverse events	Reslizumab 2 mg/kg	29	57
Total, other adverse events	Reslizumab 3 mg/kg	39	57
Total, other adverse events	Placebo	40	57
Total, serious adverse events	Reslizumab 1 mg/kg	1	55
Total, serious adverse events	Reslizumab 2 mg/kg	1	57

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22206777	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00538434

GET https://conductscience.org/api/trials/v1/NCT00538434/results?page=2

API reference For AI assistants