A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

Study Overview

• Status: Completed
• Conditions: Eosinophilic Asthma
• Intervention / Treatment: Drug: Reslizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Teva Investigational Site 121
  • Ciudad Autonoma de Buenos Aire, Argentina
    • Teva Investigational Site 126
  • Rosario-Santa Fe, Argentina
    • Teva Investigational Site 123
  • San Miguel De Tucuman - Tucuma, Argentina
    • Teva Investigational Site 120
• Brazil
  • Florianopolis, Brazil
    • Teva Investigational Site 150
  • Porto Alegre, Brazil
    • Teva Investigational Site 140
  • Porto Alegre, Brazil
    • Teva Investigational Site 144
  • Porto Alegre, Brazil
    • Teva Investigational Site 145
  • Porto Alegre, RS, Brazil
    • Teva Investigational Site 143
  • Santo André, São Paulo, Brazil
    • Teva Investigational Site 142
• Canada
  • Newmarket, Canada
    • Teva Investigational Site 104
  • Pointe-Claire, Canada
    • Teva Investigational Site 102
  • Windsor, Canada
    • Teva Investigational Site 105
• France
  • Grenoble, France
    • Teva Investigational Site 343
  • Marseille, France
    • Teva Investigational Site 342
  • Montpellier, France
    • Teva Investigational Site 341
• Germany
  • Bad Wörishofen, Germany
    • Teva Investigational Site 360
  • Berlin, Germany
    • Teva Investigational Site 361
  • Berlin, Germany
    • Teva Investigational Site 362
  • Berlin, Germany
    • Teva Investigational Site 366
  • Bochum, Germany
    • Teva Investigational Site 371
  • Dresden, Germany
    • Teva Investigational Site 365
  • Frankfurt, Germany
    • Teva Investigational Site 369
  • Hamburg, Germany
    • Teva Investigational Site 370
  • Koblenz, Germany
    • Teva Investigational Site 372
  • Leipzig, Germany
    • Teva Investigational Site 367
  • Leipzig, Germany
    • Teva Investigational Site 368
  • Mainz, Germany
    • Teva Investigational Site 363
  • Mainz, Germany
    • Teva Investigational Site 364
• Greece
  • Alexandroupolis, Greece
    • Teva Investigational Site 381
  • Athens, Greece
    • Teva Investigational Site 380
  • Heraklion, Crete, Greece
    • Teva Investigational Site 382
• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Teva Investigational Site 682
  • Seoul, Korea, Republic of
    • Teva Investigational Site 680
  • Seoul, Korea, Republic of
    • Teva Investigational Site 681
  • Seoul, Korea, Republic of
    • Teva Investigational Site 683
  • Seoul, Korea, Republic of
    • Teva Investigational Site 686
  • Suwon, Korea, Republic of
    • Teva Investigational Site 685
• Mexico
  • Ciudad De México, Mexico
    • Teva Investigational Site 205
  • Distrito Federal, Mexico
    • Teva Investigational Site 203
  • Guadalajara, JAL, Mexico
    • Teva Investigational Site 204
  • Mexico City, Mexico
    • Teva Investigational Site 207
  • Monterrey, Mexico
    • Teva Investigational Site 209
  • Tijuana, B.C., Mexico
    • Teva Investigational Site 202
• Peru
  • Cercado De Lima, Lima, Peru
    • Teva Investigational Site 223
  • Lima, Peru
    • Teva Investigational Site 220
  • Lima, Peru
    • Teva Investigational Site 221
  • Lima, Peru
    • Teva Investigational Site 222
  • Lima, Peru
    • Teva Investigational Site 225
  • Lima, Peru
    • Teva Investigational Site 226
  • Lima, Peru
    • Teva Investigational Site 227
  • Lima, Peru
    • Teva Investigational Site 229
• Romania
  • Bucharest, Romania
    • Teva Investigational Site 523
  • Bucharest, Romania
    • Teva Investigational Site 524
  • Cluj-Napoca, Romania
    • Teva Investigational Site 520
  • Iasi, Romania
    • Teva Investigational Site 521
  • Targu Mures, Romania
    • Teva Investigational Site 522
• Russian Federation
  • Moscow, Russian Federation
    • Teva Investigational Site 543
  • Moscow, Russian Federation
    • Teva Investigational Site 544
  • Moscow, Russian Federation
    • Teva Investigational Site 554
  • Moscow, Russian Federation
    • Teva Investigational Site 556
  • Moscow, Russian Federation
    • Teva Investigational Site 558
  • Moscow, Russian Federation
    • Teva Investigational Site 559
  • Novosibirsk, Russian Federation
    • Teva Investigational Site 557
  • St. Petersburg, Russian Federation
    • Teva Investigational Site 541
  • St.Petersburg, Russian Federation
    • Teva Investigational Site 540
• Slovakia
  • Bradejov, Slovakia
    • Teva Investigational Site 563
  • Levice, Slovakia
    • Teva Investigational Site 561
  • Spisska Nova Ves, Slovakia
    • Teva Investigational Site 560
  • Topolcany, Slovakia
    • Teva Investigational Site 562
• Taiwan
  • Kaohsiung, Taiwan
    • Teva Investigational Site 764
  • Taichung, Taiwan
    • Teva Investigational Site 765
  • Taipei, Taiwan
    • Teva Investigational Site 760
  • Taipei, Taiwan
    • Teva Investigational Site 761
  • Taoyuan, Taiwan
    • Teva Investigational Site 763
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Teva Investigational Site 621
  • Donetsk, Ukraine
    • Teva Investigational Site 629
  • Donetsk, Ukraine
    • Teva Investigational Site 635
  • Ivano-Frankivsk, Ukraine
    • Teva Investigational Site 630
  • Kharkiv, Ukraine
    • Teva Investigational Site 620
  • Kharkiv, Ukraine
    • Teva Investigational Site 633
  • Kyiv, Ukraine
    • Teva Investigational Site 622
  • Kyiv, Ukraine
    • Teva Investigational Site 623
  • Kyiv, Ukraine
    • Teva Investigational Site 624
  • Kyiv, Ukraine
    • Teva Investigational Site 625
  • Ternopil, Ukraine
    • Teva Investigational Site 628
  • Vinnytsya, Ukraine
    • Teva Investigational Site 626
  • Zaporizhzhia, Ukraine
    • Teva Investigational Site 631
  • Zaporizhzhia, Ukraine
    • Teva Investigational Site 632
• United States
  • Alabama
    • Mobile, Alabama, United States
      • Teva Investigational Site 48
  • California
    • Fresno, California, United States
      • Teva Investigational Site 41
    • Long Beach, California, United States
      • Teva Investigational Site 59
  • Colorado
    • Denver, Colorado, United States
      • Teva Investigational Site 47
  • Connecticut
    • Waterbury, Connecticut, United States
      • Teva Investigational Site 28
  • Florida
    • Clearwater, Florida, United States
      • Teva Investigational Site 53
    • Miami, Florida, United States
      • Teva Investigational Site 27
  • Georgia
    • Lawrenceville, Georgia, United States
      • Teva Investigational Site 25
  • Louisiana
    • Metairie, Louisiana, United States
      • Teva Investigational Site 57
  • Maine
    • Bangor, Maine, United States
      • Teva Investigational Site 46
  • Missouri
    • Saint Louis, Missouri, United States
      • Teva Investigational Site 40
  • South Carolina
    • Fort Mill, South Carolina, United States
      • Teva Investigational Site 67
  • Texas
    • Dallas, Texas, United States
      • Teva Investigational Site 44
    • El Paso, Texas, United States
      • Teva Investigational Site 69
    • San Antonio, Texas, United States
      • Teva Investigational Site 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea.
• The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
• The patient has a current blood eosinophil level of at least 400/μL.
• The patient has airway reversibility of at least 12% to beta-agonist administration.
• The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before the 1st dose of study drug) visits.
• The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient's baseline asthma therapy regimen (including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the study.
• All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine).
• Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
• Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent.
• The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis.
• The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow-up evaluation as specified in this protocol.
• Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only.

Exclusion Criteria:

• The patient has a clinically meaningful co-morbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
• The patient has known hypereosinophilic syndrome.
• The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
• The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
• The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior to screening.
• The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
• The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
• The patient has participated in any investigative drug or device study within 30 days prior to screening.
• The patient has participated in any investigative biologics study within 6 months prior to screening.
• Other exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.	Drug: Placebo; Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.
Experimental: Reslizumab 3.0 mg/kg; Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.	Drug: Reslizumab; Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.; Other Names: Cinquil; humanized monoclonal antibody; CEP-38072

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment	An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.; asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization. CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means.	Day 1 to Month 12
Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)	An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.; asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors. Results are offered as adjusted means.	Day 1 to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16	The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits. Positive change from baseline scores indicate improvement in quality of life.	Day 1 (baseline, pre-dose), Week 16
Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures	The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control.	Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures	The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms. The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms.	Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16	FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control.	Day 1 (baseline, pre-dose), Week 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures	FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well. Positive change from baseline scores indicate improvement in asthma control.	Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16
Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)	An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.; asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization. CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).	Day 1 to Day 526 (longest treatment time plus 2 weeks)
Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures	SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3. The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. Negative change from baseline scores indicate improvement in asthma control.	Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16
Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures	The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded. The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field. Negative change from baseline values correlate to reduced asthma severity.	Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal
Participants With Treatment-Emergent Adverse Events TEAE)	An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.	Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values	Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values. Significance criteria: Blood urea nitrogen: >=10.71 mmol/L; Creatinine: >=177 μmol/L; Urate: M>=625, F>=506 μmol/L; Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN); Alanine aminotransferase (ALT): >=3*ULN; GGT = gamma-glutamyl transpeptidase: >= 3*ULN; Total bilirubin: >=34.2 μmol/L; White blood cells (low): <=3.0*10^9/L; White blood cells (high): >=20*10^9/L; Hemoglobin (age >=18 years): M<=115, F<=95 g/dL; Hematocrit (age >=18 years): M<0.37, F<0.32 L/L; Eosinophils/leukocytes: >=10.0%; Platelets: <=75*10^9/L; Neutrophils: <=1.0*10^9/L; Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline	Week 4 to Week 52
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values	Data represents participants with potentially clinically significant (PCS) vital sign values. Significance criteria; Sitting pulse (high): >100 and increase of >= 30 beats/minute; Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg; Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg; Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0; Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg; Respiratory rate (low): <6 breaths/minute; Respiratory rate (high): >24 and increase of >=10 breaths/minute; Body temperature (low): <35.8° Celsius; Body temperature (high): >=38.1 and increase of >=1.1° Celsius	Week 4 to Week 52
Participants With a Positive Anti-Reslizumab Antibody Status During Study	Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.	Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

General Publications

• Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.
• Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.
• Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting beta2-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.
• Bateman ED, Djukanovic R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.
• Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.
• Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.
• Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum In: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia; Anti-Asthmatic Agents; Respiratory System Agents; Reslizumab
• Other Study ID Numbers: C38072/3083; 2010-024006-35 (EudraCT Number)