Eosinophilic EsophagitisPhase 3NCT00635089
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
A Phase 3 study testing reslizumab in people with Eosinophilic Esophagitis, run by Ception Therapeutics at 36 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- reslizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 36 sitesin 2 countries
- Study dates
- Jul 2008to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent
- Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
- Did not withdraw from Study Res-05-0002 due to drug related adverse event
- Completed End of Treatment Visit for Study Res-05-0002
Who cannot join
- Pregnant or nursing females
- Concurrent Immunodeficiency
- Current use of immunosuppressive drugs
- Did not tolerate study drug in Study Res-05-0002
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States34 sites
Children's Center for Digestive Health Care
Atlanta, Georgia, 30342
Denver Childrens At Aurora, Colorado
Aurora, Colorado, 80045
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
The Children's Hospital of Alabama
Birmingham, Alabama, 35233
Tuft's Floating Hospital
Boston, Massachusetts, 02111
1st Allergy and Clinical Research Center
Centennial, Colorado, 80112
University of Chicago
Chicago, Illinois, 60637
Children'S Memorial Hospital Division of Gastroenterology Hepatology & Nutrition
Chicago, Illinois, 66014
Cincinnati Children's
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwest Medical Center
Dallas, Texas, 75390
Pediatric Allergy and Immunology of Duke Medical Center
Durham, North Carolina, 27720
Greenville Health System
Greenville, South Carolina, 29615
Kaiser Permanente Hospital- Pediatric Gastroenterology
Hayward, California, 94545
Riley Hospital for Children
Indianapolis, Indiana, 46202
Las Vegas Pediatric Gastroenterology Associates
Las Vegas, Nevada, 89109
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, 08330
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mount Sinai School of Medicine, Pediatrics
New York, New York, 10029
Creighton University Medical Center
Omaha, Nebraska, 68131
Children'S Hospital of Orange County Pediatric Subspecialty Faculty Division of Allergy and Asthma
Orange, California, 92868
Pediatric Allergy/Immunology
Palo Alto, California, 94305
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Minnesota Gastroenterology
Plymouth, Minnesota, 55446
Children's Pavilion
Richmond, Virginia, 23298-0264
Carilion Medical Center for Children
Roanoke, Virginia, 24013
University of Utah School of Medicine
Salt Lake City, Utah, 84113
Children's Hospital of San Diego
San Diego, California, 92123
Saint Louis University
St Louis, Missouri, 63104
State University of New York (SUNY)
Syracuse, New York, 13210
University of Arizona Dept. of Pediatrics
Tucson, Arizona, 85724
Center for Digestive Allergic and Immunologic Diseases
Williamsville, New York, 14221
Thomas Jefferson University Medical College
Wilmington, Delaware, 19803
Canada2 sites
Pediatric Allergy and Immunology
Edmonton, Alberta, T6G 2C8
University of Montreal
Montreal, Quebec, H3T 1C5
About this study
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
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.
Read the detailed description
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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- reslizumab
- Keywords
- Eosinophilic Esophagitis, Cinquil
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reslizumabDrug
Also called Cinquil™, CEP-38072, CTx55700
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Reslizumab | Other | Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly Receives: Drug: reslizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, or Discontinuation Due to AEs
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.
Measured: From start of study drug until end of treatment (mean [standard deviation {SD}] duration of treatment was 30.0 [5.89] months)
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
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).
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Laboratory Test Results or Urinalysis Abnormality
Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Vital Signs Value
Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Number of Participants With Newly Diagnosed Physical Examination Abnormalities at Endpoint
HEENT=head, eyes, ears, nose and throat.
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Infusion Site Evaluations
The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.
Measured: 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)
Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
Number of participants receiving therapeutic classes of concomitant medications.
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Secondary outcomes (7)
Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
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.
Measured: Baseline, Week 16 or early withdrawal (if before Week 16)
Participant's EoE Predominant Symptoms Over Time
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.
Measured: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
Physician's EoE Global Assessment Over Time
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.
Measured: Every 3 weeks from Day 0 up to Week 42 (mean [SD] duration of treatment was 30.0 [5.89] months)
Mean Change From Baseline to Endpoint in Selected Child Health Questionnaire (CHQ) Scores
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.
Measured: Baseline through Endpoint (last visit; mean [SD] duration of treatment was 30.0 [5.89] months)
Dietary Question Responses at Endpoint
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.)
Measured: Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)
Reslizumab Serum Concentrations
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.
Measured: 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.
Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA)
Using a validated enzyme-linked immunosorbent assay (ELISA), the number of participants who had at least 1 confirmed positive value for ADA, either on day 0 after having received reslizumab in the double-blind study Res-05-0002 (NCT00538434) or during the course of the open-label study.
Measured: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ception Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, MD, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635089
- Sponsor's protocol ID
- Res-5-0004
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2008
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00635089
- Acronym / sponsor ID
- Res-5-0004
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Cinquil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Ception TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Cephalon
- Study start
- Jul 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Reslizumab | Other | Drug: reslizumabOpen-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Received at least two doses of study drug in Study Res-05-0002 (NCT00538434)
- Did not withdraw from Study Res-05-0002 due to drug related adverse event
- Completed End of Treatment Visit for Study Res-05-0002
Key exclusion criteria (4 listed)
- Pregnant or nursing females
- Concurrent Immunodeficiency
- Current use of immunosuppressive drugs
- Did not tolerate study drug in Study Res-05-0002
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reslizumabAlso: Cinquil™, CEP-38072, CTx55700 | Drug | Open-Label Reslizumab |
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 treatment was 30.0 [5.89] months)
Serum chemistry laboratory tests performed include: calcium, phosphorus, magnesium, sodium, potassium, chloride, creatinine, glucose [nonfasting], blood urea nitrogen, total cholesterol, uric acid, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma glutamyl transpeptidase, alkaline phosphatase, bicarbonate, creatine kinase, total protein, albumin, total bilirubin, direct bilirubin, indirect bilirubin. Urinalysis tests performed include: protein, glucose, ketones, bilirubin, urobilinogen, nitrite content, pH, specific gravity, white blood cells, microscopic (red blood cells, white blood cells, casts, crystals).
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)
Low systolic blood pressure: < 90 and decrease (↓) of 30 mm Hg from baseline (BL) (ages 5-18); high systolic blood pressure: > 160 and increase (↑) of 30 mm Hg from BL (age 5-12), > 130 and ↑ of 30 mm Hg from BL (age 13-18). Low diastolic blood pressure: < 45 and ↓ of 12 mm Hg from BL (age 5-12), < 55 and ↓ of 12 mm Hg from BL (age 13-18), < 50 and ↓ of 15 mm Hg from BL; high diastolic blood pressure: > 85 and ↑ of 12 mm Hg from BL (ages 5-18). Low heart rate: < 80 and and ↓ of 30 beats per minute (bpm) from BL (age 5-12), < 60 and and ↓ of 30 bpm from BL (age 13-18), < 50 and and ↓ of 15 bpm from BL (age > 18); high heart rate: > 120 and ↑ of 30 bpm from BL (age 5-12), > 100 and ↑ of 30 bpm from BL (age 13-18), > 100 and ↑ of 15 bpm from BL (age > 18). Low oral body temperature: < 35.8° Celsius (age 5 to >18); high oral body temperature: > 38.1° C and ↑ 2° Celsius from BL (age 5-18).
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)
HEENT=head, eyes, ears, nose and throat.
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)
The infusion site was assessed before treatment and within 30 minutes after the end of the infusion at each monthly treatment visit (or at early withdrawal if before Week 16). The infusion site was graded according to a 5-point scale as follows: 0=no tenderness at IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 1=tender IV site, no erythema, no swelling, no induration, no purulence, no palpable venous cord; 2=tender IV site with erythema, some degree of swelling, no induration, no purulence, no palpable venous cord; 3=tender IV site with erythema and swelling, with induration or palpable venous cord, no purulence; 4=frank vein thrombosis, along with all signs of grade 3 with purulence; IV may stop running because of thrombosis. After the 16-week visit, formal infusion site evaluations were not continued. However, any infusion site reactions were recorded as adverse events and graded as other adverse events.
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)
Number of participants receiving therapeutic classes of concomitant medications.
7 secondary outcomes
Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts
Time frame: Baseline, Week 16 or early withdrawal (if before Week 16)
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)
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)
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)
Dietary Question Responses at Endpoint
Time frame: Study endpoint (mean [SD] duration of treatment was 30.0 [5.89] months)
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.
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor's Medical Expert, MD study director
Cephalon
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing reslizumab in people with Eosinophilic Esophagitis, run by Ception Therapeutics at 36 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.