A Phase 3 interventional study of reslizumab in Eosinophilic Esophagitis, sponsored by Ception Therapeutics. Completed at 36 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by Ception Therapeutics · Phase 3, Interventional, and Treatment
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.
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.
322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.
This study's enrollment of 190 is above the median of 66 across 215 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Ception Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
Drug: reslizumab
Also known as: Cinquil™, CEP-38072, CTx55700
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.
Time frame: 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).
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 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).
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 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).
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 With Newly Diagnosed Physical Examination Abnormalities at Endpoint
HEENT=head, eyes, ears, nose and throat.
Time frame: 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.
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)
Therapeutic Classification of Concomitant Medications in at Least 10% of Participants
Number of participants receiving therapeutic classes of concomitant medications.
Time frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.)
Time frame: 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.
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)
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.
Time frame: From start of study drug until end of treatment (mean [SD] duration of treatment was 30.0 [5.89] months)
| Milestone | Open-Label Reslizumab |
|---|---|
| Started | 190 |
| Completed >/= 16 weeks of study | 181 |
| Completed | 112 |
| Not completed | 78 |
| Withdrew: Adverse event | 7 |
| Withdrew: Lack of efficacy | 28 |
| Withdrew: Protocol deviation | 4 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Other | 31 |
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.
| participants | Open-Label Reslizumab |
|---|---|
| Any AEs | 177 |
| Severe AEs | 38 |
| Treatment-related AEs | 63 |
| Deaths | 0 |
| Other Serious AEs | 21 |
| Withdrawn from study due to AEs | 7 |
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.
| eosinophils/high power field (hpf) | Open-Label Reslizumab |
|---|---|
| Mean Change From Baseline to Endpoint in Peak Esophageal Eosinophil Counts | -62.0 ± 77.97 |
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).
| participants | Open-Label Reslizumab |
|---|---|
| Hemoglobin </= 100 g/L | 1 |
| Hematocrit < 0.30 L/L | 1 |
| Leukocytes </= 3*10^9/L | 7 |
| Neutrophils </= 1*10^9/L | 16 |
| Platelets </= 75*10^9/L | 3 |
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).
| participants | Open-Label Reslizumab |
|---|---|
| Abnormal Serum Chemistry Laboratory Test Results | 0 |
| Urinalysis Abnormalities | 0 |
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).
| participants | Open-Label Reslizumab |
|---|---|
| Low systolic blood pressure | 21 |
| High systolic blood pressure | 18 |
| Low diastolic blood pressure | 88 |
| High diastolic blood pressure | 27 |
| Low heart rate | 42 |
| High heart rate | 22 |
| Low oral temperature | 72 |
| High oral temperature | 2 |
HEENT=head, eyes, ears, nose and throat.
| participants | Open-Label Reslizumab |
|---|---|
| General appearance | 0 |
| HEENT | 7 |
| Neck/thyroid | 0 |
| Skin | 4 |
| Lymph nodes | 0 |
| Heart | 1 |
| Chest and lungs | 3 |
| Neurological cranial nerves | 0 |
| Neurological strength | 0 |
| Neurological sensation | 0 |
| Neurological reflexes | 0 |
| Other | 9 |
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.
| participants | Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
| Day 0; n=190 | 178 | 11 | 1 | 0 | 0 |
| Week 4; n=188 | 179 | 8 | 1 | 0 | 0 |
| Week 8; n=184 | 181 | 2 | 1 | 0 | 0 |
| Week 12; n=181 | 175 | 4 | 1 | 1 | 0 |
| Week 16; n=159 | 154 | 4 | 1 | 0 | 0 |
| Endpoint; n=190 | 185 | 4 | 1 | 0 | 0 |
| Any time; n=190 | 190 | 25 | 3 | 1 | 0 |
Number of participants receiving therapeutic classes of concomitant medications.
| participants | Open-Label Reslizumab |
|---|---|
| Any concomitant medication | 176 |
| Analgesics | 93 |
| Antibacterials for systemic use | 117 |
| Antiemetics and antinauseants | 28 |
| Antihistamines for systemic use | 123 |
| Antiinflammatory and antirheumatic products | 83 |
| Antipruritics, including antihistamine,anesthetic | 26 |
| Antivirals for systemic use | 24 |
| Corticosteroids for systemic use | 40 |
| Corticosteroids, dermatological preparations | 27 |
| Cough and cold preparations | 55 |
| Drugs for acid-related disorders | 59 |
| Drugs for obstructive airway diseases | 93 |
| Laxatives | 26 |
| Mineral supplements | 20 |
| Nasal preparations | 73 |
| Ophthalmologicals | 19 |
| Psychoanaleptics | 49 |
| Psycholeptics | 33 |
| Vaccines | 31 |
| Vitamins | 36 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| units on a scale | Open-Label Reslizumab |
|---|---|
| Global Health; n=181 | 4.6 ± 20.62 |
| Physical Summary Scale; n=170 | 3.7 ± 9.26 |
| Psychosocial Summary Scale; n=170 | 3.1 ± 8.83 |
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.)
| participants | Maintained Diet From Beginning of Double-blind Study | Changed Diet From Beginning of Double-blind Study | Changed by Increasing Consistency of Food | Changed by Eating Foods That Previously Worsened EoE |
|---|---|---|---|---|
| Dietary Question Responses at Endpoint | 124 | 63 | 21 | 46 |
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.
| µg/mL | Open-Label Reslizumab: 1 mg/kg | Open-Label Reslizumab: 2 mg/kg | Open-Label Reslizumab: 3 mg/kg | Open-Label Reslizumab: Overall |
|---|---|---|---|---|
| Reslizumab Serum Concentrations | 15.747 ± 11.293 | 29.507 ± 20.592 | 41.360 ± 54.952 | 21.202 ± 17.684 |
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.
| participants | Open-Label Reslizumab |
|---|---|
| Number of Participants With >/= 1 Confirmed Positive Value for Anti-drug Antibodies (ADA) | 6 |
Collected over Day 0 through the end of study. The mean duration of treatment within the open-label extension for all participants was 24.7 months (range, 0.0 to 40.5 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-Label Reslizumab | — | 21/190 (11.1%) | 167/190 (87.9%) |
| Event | Open-Label Reslizumab |
|---|---|
| Abdominal painGastrointestinal disorders | 2/190 |
| Road traffic accidentInjury, poisoning and procedural complications | 2/190 |
| DepressionPsychiatric disorders | 2/190 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/190 |
| NeutropeniaBlood and lymphatic system disorders | 1/190 |
| Abdominal pain lowerGastrointestinal disorders | 1/190 |
| ConstipationGastrointestinal disorders | 1/190 |
| Hiatus herniaGastrointestinal disorders | 1/190 |
| Anaphylactic reactionImmune system disorders | 1/190 |
| AppendicitisInfections and infestations | 1/190 |
| Event | Open-Label Reslizumab |
|---|---|
| Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders | 53/190 |
| HeadacheNervous system disorders | 50/190 |
| Upper respiratory tract infectionInfections and infestations | 45/190 |
| NasopharyngitisInfections and infestations | 40/190 |
| InfluenzaInfections and infestations | 37/190 |
| SinusitisInfections and infestations | 35/190 |
| CoughRespiratory, thoracic and mediastinal disorders | 31/190 |
| Gastroenteritis viralInfections and infestations | 30/190 |
| PyrexiaGeneral disorders | 29/190 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 28/190 |
| Age, Continuous(years) | Open-Label Reslizumab |
|---|---|
| Mean | 12.1 ± 3.97 |
| Age, Customized(participants) | Open-Label Reslizumab |
|---|---|
| 5 to 11 years | 81 |
| 12 to 19 years | 109 |
| Sex: Female, Male(Participants) | Open-Label Reslizumab |
|---|---|
| Female | 42 |
| Male | 148 |
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