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A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03052725
Collaborator
(none)
391
Enrollment
126
Locations
1
Arm
11.5
Actual Duration (Months)
3.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
391 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Actual Study Start Date :
Mar 10, 2017
Actual Primary Completion Date :
Feb 22, 2018
Actual Study Completion Date :
Feb 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: reslizumab 110 mg

Reslizumab was administered as 110 mg subcutaneous (sc) injection in the thigh, abdomen, or upper arm(s) once every 4 weeks for a total of 9 doses.

Drug: reslizumab
Reslizumab was provided in a pre-filled syringe.
Other Names:
  • CEP38072

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Participants With Treatment-Emergent Adverse Events (TEAEs) [Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.]

      An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. 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.

    Secondary Outcome Measures

    1. Participants With Potentially Clinically Significant Abnormal Hematology Values [Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits]

      Participants are included in the counts if the worst study value reaches the following clinically significant levels: Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0

    2. Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values [Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits]

      Participants are included in the counts if the worst study value reaches the following clinically significant levels: Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0

    3. Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity [Weeks 4, 8, 12, 16, 20, 24, 28, and 36]

      The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration. Severity was rated on a 4-level scale of none, mild, moderate and severe.

    4. Participants With Potentially Clinically Significant Abnormal Vital Sign Values [Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits]

      Participants are included in the counts if the worst study value reaches the following clinically significant levels: Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius

    5. Annualized Rate of Clinical Asthma Exacerbations (CAEs) [Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.]

      Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.

    6. Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits [Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.]

      Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.

    7. Mean Number of Days of Hospital Stay During the Treatment Period [Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug]

      Participants with no hospitalizations are included.

    8. Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period [Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug]

      Participants with no school or work days missed due to asthma are included in the counts.

    9. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36 [Week 0 (baseline), Weeks 8, 24, 36]

      The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters. Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.

    10. Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36 [Week 0 (baseline), Weeks 1, 4, 8, 24, 36]

      A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

    11. Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36 [Week 0 (baseline), Weeks 16-20, Weeks 32-36]

      Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose. Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range. Percent change = 100 * (absolute change / baseline dose)

    12. Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36 [Baseline (Week 0), Weeks 1, 4, 8, 24, 36]

      Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages. The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.

    13. Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36 [Baseline (Week 0), Weeks 8, 24, 36]

      The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.

    14. Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36 [Baseline (Week 0), Weeks 8, 24, 36]

      The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Positive change from baseline values indicate improved quality of life.

    15. Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses [Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal]

      Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample. Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb). The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.

    16. Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51) [Week 51]

      The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

    ~~ Additional criteria apply, please contact the investigator for more information

    Exclusion Criteria:

    • Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.

    • The patient has any clinically significant, uncontrolled medical condition

    • The patient has another confounding underlying lung disorder

    • The patient has a known/diagnosed hypereosinophilic syndrome.

    • The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.

    • The patient is a pregnant or lactating woman

    • The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.

    • The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS

    • The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.

    • The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

    • Additional criteria apply, please contact the investigator for more information

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 14647 Birmingham Alabama United States 35209
    2 Teva Investigational Site 14631 Bakersfield California United States 93301
    3 Teva Investigational Site 14648 Huntington Beach California United States 92647
    4 Teva Investigational Site 14654 Stockton California United States 95207
    5 Teva Investigational Site 14626 Aventura Florida United States 33180
    6 Teva Investigational Site 14634 Homestead Florida United States 33030
    7 Teva Investigational Site 14650 Miami Florida United States 33015
    8 Teva Investigational Site 14629 Miami Florida United States 33173
    9 Teva Investigational Site 14624 Orlando Florida United States 32819
    10 Teva Investigational Site 14638 Tallahassee Florida United States 32308
    11 Teva Investigational Site 14619 Tampa Florida United States 33607
    12 Teva Investigational Site 14642 Buford Georgia United States 30518
    13 Teva Investigational Site 14651 Chicago Illinois United States 60612
    14 Teva Investigational Site 14645 Michigan City Indiana United States 46360
    15 Teva Investigational Site 14620 Owensboro Kentucky United States 42301
    16 Teva Investigational Site 14623 Lafayette Louisiana United States 70508
    17 Teva Investigational Site 14627 North Dartmouth Massachusetts United States 02747
    18 Teva Investigational Site 14644 Boys Town Nebraska United States 68010
    19 Teva Investigational Site 14652 Ocean City New Jersey United States 07712
    20 Teva Investigational Site 14632 Lake Success New York United States 11042
    21 Teva Investigational Site 14646 New York New York United States 10016-9196
    22 Teva Investigational Site 14633 Cincinnati Ohio United States 45231
    23 Teva Investigational Site 14653 Cleveland Ohio United States 44106
    24 Teva Investigational Site 14621 Edmond Oklahoma United States 73034
    25 Teva Investigational Site 14643 Jenkintown Pennsylvania United States 19046
    26 Teva Investigational Site 14622 Pittsburgh Pennsylvania United States 15241
    27 Teva Investigational Site 14630 East Providence Rhode Island United States 02914
    28 Teva Investigational Site 14649 Warwick Rhode Island United States 02886
    29 Teva Investigational Site 14655 Knoxville Tennessee United States 37909
    30 Teva Investigational Site 14639 Corsicana Texas United States 75110
    31 Teva Investigational Site 14640 Dallas Texas United States 75225
    32 Teva Investigational Site 14641 Provo Utah United States 84604
    33 Teva Investigational Site 14628 Abingdon Virginia United States 24210
    34 Teva Investigational Site 14635 Falls Church Virginia United States 22044
    35 Teva Investigational Site 37082 Bruxelles Belgium 1200
    36 Teva Investigational Site 37081 Erpent Belgium 5101
    37 Teva Investigational Site 37083 Gent Belgium 9000
    38 Teva Investigational Site 11134 Etobicoke Ontario Canada M9V 4B4
    39 Teva Investigational Site 11133 Vancouver Canada V5Z 4E1
    40 Teva Investigational Site 54151 Breclav Czechia 690 74
    41 Teva Investigational Site 54150 Jablonec nad Nisou Czechia 46601
    42 Teva Investigational Site 54148 Jindrichuv Hradec Czechia 377 38
    43 Teva Investigational Site 54149 Tabor Czechia 39001
    44 Teva Investigational Site 35229 Le Kremlin Bicetre France 94270
    45 Teva Investigational Site 35227 Strasbourg France 67091
    46 Teva Investigational Site 35228 Toulouse France 31059
    47 Teva Investigational Site 32676 Berlin-Tempelhof Germany 12099
    48 Teva Investigational Site 32670 Berlin Germany 10717
    49 Teva Investigational Site 32680 Berlin Germany 10969
    50 Teva Investigational Site 32673 Berlin Germany 14059
    51 Teva Investigational Site 32675 Frankfurt/Main Germany 60389
    52 Teva Investigational Site 32679 Frankfurt Germany 60596
    53 Teva Investigational Site 32678 Hamburg Germany 22299
    54 Teva Investigational Site 32681 Hannover Germany 30173
    55 Teva Investigational Site 32677 Koblenz Germany 56068
    56 Teva Investigational Site 32672 Leipzig Germany 04357
    57 Teva Investigational Site 32671 Leipzig Germany 4275
    58 Teva Investigational Site 32674 Lubeck Germany 23552
    59 Teva Investigational Site 51291 Balassagyarmat Hungary 2660
    60 Teva Investigational Site 51290 Budapest Hungary H-1036
    61 Teva Investigational Site 51293 Csorna Hungary 9300
    62 Teva Investigational Site 51292 Debrecen Hungary 4032
    63 Teva Investigational Site 51283 Debrecen Hungary 4043
    64 Teva Investigational Site 51286 Godollo Hungary 2100
    65 Teva Investigational Site 51284 Gyor Hungary 9023
    66 Teva Investigational Site 51285 Hajdunanas Hungary 4080
    67 Teva Investigational Site 51282 Kapuvar Hungary 9330
    68 Teva Investigational Site 51289 Szigetvar Hungary 7900
    69 Teva Investigational Site 51280 Szombathely Hungary 9700
    70 Teva Investigational Site 51281 Tatabanya Hungary 2800
    71 Teva Investigational Site 51287 Veszprem Hungary 8200
    72 Teva Investigational Site 80136 Ashkelon Israel 7830604
    73 Teva Investigational Site 80129 Haifa Israel 3436212
    74 Teva Investigational Site 80131 Jerusalem Israel 91031
    75 Teva Investigational Site 80135 Jerusalem Israel 91120
    76 Teva Investigational Site 80134 Kfar Saba Israel 44281
    77 Teva Investigational Site 80132 Petah Tikva Israel 49100
    78 Teva Investigational Site 80133 Ramat Gan Israel 5262100
    79 Teva Investigational Site 80130 Rehovot Israel 76100
    80 Teva Investigational Site 53405 Bialystok Poland 15-044
    81 Teva Investigational Site 53402 Gdansk Poland 80952
    82 Teva Investigational Site 53399 Krakow Poland 31-624
    83 Teva Investigational Site 53408 Lodz Poland 90-153
    84 Teva Investigational Site 53403 Lubin Poland 59-300
    85 Teva Investigational Site 53407 Ostrow Wielkopolski Poland 63-400
    86 Teva Investigational Site 53401 Poznan Poland 60-214
    87 Teva Investigational Site 53404 Tarnow Poland 33-100
    88 Teva Investigational Site 53406 Wroclaw Poland 54-239
    89 Teva Investigational Site 52115 Brasov Romania 500051
    90 Teva Investigational Site 52116 Brasov Romania 500086
    91 Teva Investigational Site 52113 Cluj-Napoca Romania 400371
    92 Teva Investigational Site 52117 Timisoara Romania 300310
    93 Teva Investigational Site 50460 Barnaul Russian Federation 656024
    94 Teva Investigational Site 50453 Kemerovo Russian Federation 650002
    95 Teva Investigational Site 50461 Kemerovo Russian Federation 650099
    96 Teva Investigational Site 50456 Moscow Russian Federation 115478
    97 Teva Investigational Site 50455 Novosibirsk Russian Federation 630091
    98 Teva Investigational Site 50454 Saint-Petersburg Russian Federation 194223
    99 Teva Investigational Site 50457 St. Petersburg Russian Federation 197022
    100 Teva Investigational Site 50458 Tomsk Russian Federation 634063
    101 Teva Investigational Site 31219 Barcelona Spain 8041
    102 Teva Investigational Site 31218 Valencia Spain 46017
    103 Teva Investigational Site 31217 Valencia Spain 46026
    104 Teva Investigational Site 58283 Chernivtsi Ukraine 58023
    105 Teva Investigational Site 58304 Dnipropetrovsk Ukraine 49074
    106 Teva Investigational Site 58287 Dnipropetrovsk Ukraine 49101
    107 Teva Investigational Site 58295 Ivano-Frankivsk Ukraine 76018
    108 Teva Investigational Site 58293 Kharkiv Ukraine 61002
    109 Teva Investigational Site 58289 Kharkiv Ukraine 61007
    110 Teva Investigational Site 58284 Kharkiv Ukraine 61035
    111 Teva Investigational Site 58288 Kharkiv Ukraine 61039
    112 Teva Investigational Site 58302 Kremenchuk Ukraine 39617
    113 Teva Investigational Site 58292 Kryvyi Rih Ukraine 50082
    114 Teva Investigational Site 58299 Kyiv Ukraine 04201
    115 Teva Investigational Site 58303 Kyiv Ukraine 2091
    116 Teva Investigational Site 58282 Kyiv Ukraine 3049
    117 Teva Investigational Site 58285 Kyiv Ukraine 3680
    118 Teva Investigational Site 58286 Kyiv Ukraine 3680
    119 Teva Investigational Site 58291 Kyiv Ukraine 4050
    120 Teva Investigational Site 58296 Kyiv Ukraine 4107
    121 Teva Investigational Site 58290 Kyiv Ukraine ?03680
    122 Teva Investigational Site 58297 Sumy Ukraine 40022
    123 Teva Investigational Site 58301 Vinnytsia Ukraine 21001
    124 Teva Investigational Site 58294 Vinnytsya Ukraine 21001
    125 Teva Investigational Site 58298 Zaporizhzhya Ukraine 69063
    126 Teva Investigational Site 58300 Zaporizhzhya Ukraine 69118

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT03052725
    Other Study ID Numbers:
    • C38072-AS-30066
    • 2016-004661-23
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma
    Pulmonary Eosinophilia
    Reslizumab

    Study Results

    Participant Flow

    Recruitment Details A total of 392 patients with severe eosinophilic asthma rolled over from Study 30025 or 30027, and 391 of these patients (at 125 centers) were enrolled into this extension study and treated with reslizumab. One patient withdrew consent after completing Study 30025 and before enrolling in Study 30066.
    Pre-assignment Detail Of the 391 patients enrolled, 112 (29%) enrolled seamlessly and 279 (71%) enrolled non-seamlessly, meaning there was a time gap between completion of the parent study and start of this extension study.
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg: Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Period Title: Overall Study
    STARTED 194 197
    Safety Analysis Set 194 196
    COMPLETED 46 47
    NOT COMPLETED 148 150

    Baseline Characteristics

    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg: Previous Treatment Reslizumab Total
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Total of all reporting groups
    Overall Participants 194 197 391
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.4
    (14.85)
    52.5
    (15.62)
    51.5
    (15.26)
    Age, Customized (Count of Participants)
    12 to <18 years
    9
    4.6%
    8
    4.1%
    17
    4.3%
    18 to <65 years
    156
    80.4%
    141
    71.6%
    297
    76%
    >=65 years
    29
    14.9%
    48
    24.4%
    77
    19.7%
    Sex: Female, Male (Count of Participants)
    Female
    112
    57.7%
    122
    61.9%
    234
    59.8%
    Male
    82
    42.3%
    75
    38.1%
    157
    40.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    18
    9.3%
    8
    4.1%
    26
    6.6%
    Not Hispanic or Latino
    174
    89.7%
    187
    94.9%
    361
    92.3%
    Unknown or Not Reported
    2
    1%
    2
    1%
    4
    1%
    Race/Ethnicity, Customized (Count of Participants)
    White
    182
    93.8%
    185
    93.9%
    367
    93.9%
    Black
    7
    3.6%
    10
    5.1%
    17
    4.3%
    Asian
    3
    1.5%
    2
    1%
    5
    1.3%
    Other
    2
    1%
    0
    0%
    2
    0.5%
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    79.78
    (17.647)
    81.22
    (18.712)
    80.49
    (18.174)
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    28.377
    (5.8288)
    28.880
    (5.9672)
    28.627
    (5.8954)
    Systemic Corticosteroid (OCS) Use at Baseline (mg prednisolone or equivalent) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg prednisolone or equivalent]
    12.01
    (10.870)
    12.26
    (10.760)
    12.14
    (10.756)
    Region Group (Count of Participants)
    U.S./Canada
    47
    24.2%
    41
    20.8%
    88
    22.5%
    Europe
    131
    67.5%
    136
    69%
    267
    68.3%
    Other
    16
    8.2%
    20
    10.2%
    36
    9.2%

    Outcome Measures

    1. Primary Outcome
    Title Participants With Treatment-Emergent Adverse Events (TEAEs)
    Description An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. 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.
    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    >=1 TEAE
    102
    52.6%
    114
    57.9%
    >=1 treatment-related TEAE
    7
    3.6%
    6
    3%
    >=1 serious TEAE
    5
    2.6%
    11
    5.6%
    >=1 treatment-related, serious TEAE
    0
    0%
    0
    0%
    >=1 TEAE leading to discontinuation
    2
    1%
    0
    0%
    >=1 TEAE leading to death
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Participants With Potentially Clinically Significant Abnormal Hematology Values
    Description Participants are included in the counts if the worst study value reaches the following clinically significant levels: Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0
    Time Frame Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set of participants with a baseline and post-baseline result for each variable
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 192 192
    Participants with >=1 abnormality
    8
    4.1%
    5
    2.5%
    Eosinophils (high)
    1
    0.5%
    0
    0%
    Hematocrit (low)
    4
    2.1%
    2
    1%
    Hemoglobin (low)
    2
    1%
    0
    0%
    Leukocytes (high)
    0
    0%
    1
    0.5%
    Leukocytes (low)
    2
    1%
    0
    0%
    Neutrophils (low)
    1
    0.5%
    1
    0.5%
    Platelets
    0
    0%
    1
    0.5%
    3. Secondary Outcome
    Title Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values
    Description Participants are included in the counts if the worst study value reaches the following clinically significant levels: Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0
    Time Frame Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set of participants with a baseline and post-baseline result for each variable
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 193 192
    Participants with >=1 abnormality
    12
    6.2%
    10
    5.1%
    Alanine Aminotransferase (high)
    1
    0.5%
    2
    1%
    Aspartate Aminotransferase (high)
    1
    0.5%
    1
    0.5%
    Bilirubin (high)
    2
    1%
    1
    0.5%
    Blood Urea Nitrogen (high)
    2
    1%
    4
    2%
    Creatine Phosphokinase (high)
    2
    1%
    1
    0.5%
    Creatine Phosphokinase (medium high)
    6
    3.1%
    4
    2%
    Creatinine (high)
    0
    0%
    1
    0.5%
    4. Secondary Outcome
    Title Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity
    Description The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration. Severity was rated on a 4-level scale of none, mild, moderate and severe.
    Time Frame Weeks 4, 8, 12, 16, 20, 24, 28, and 36

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Pain - None
    191
    98.5%
    194
    98.5%
    Pain - Mild
    3
    1.5%
    2
    1%
    Pain - Moderate
    0
    0%
    0
    0%
    Pain - Severe
    0
    0%
    0
    0%
    Tenderness - None
    193
    99.5%
    192
    97.5%
    Tenderness - Mild
    1
    0.5%
    4
    2%
    Tenderness - Moderate
    0
    0%
    0
    0%
    Tenderness - Severe
    0
    0%
    0
    0%
    Erythema - None
    191
    98.5%
    188
    95.4%
    Erythema - Mild
    2
    1%
    7
    3.6%
    Erythema - Moderate
    1
    0.5%
    1
    0.5%
    Erythema - Severe
    0
    0%
    0
    0%
    Warmth - None
    192
    99%
    192
    97.5%
    Warmth - Mild
    1
    0.5%
    4
    2%
    Warmth - Moderate
    1
    0.5%
    0
    0%
    Warmth - Severe
    0
    0%
    0
    0%
    Swelling - None
    191
    98.5%
    190
    96.4%
    Swelling - Mild
    2
    1%
    5
    2.5%
    Swelling - Moderate
    1
    0.5%
    1
    0.5%
    Swelling - Severe
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Participants With Potentially Clinically Significant Abnormal Vital Sign Values
    Description Participants are included in the counts if the worst study value reaches the following clinically significant levels: Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius
    Time Frame Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set of participants with a baseline and post-baseline result for each variable
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 193 196
    Participants with >=1 abnormality
    20
    10.3%
    16
    8.1%
    Diastolic Blood Pressure - High
    0
    0%
    1
    0.5%
    Pulse Rate - High
    1
    0.5%
    2
    1%
    Respiratory Rate - High
    2
    1%
    0
    0%
    Systolic Blood Pressure - High
    2
    1%
    0
    0%
    Temperature - High
    1
    0.5%
    0
    0%
    Temperature - Low
    14
    7.2%
    13
    6.6%
    6. Secondary Outcome
    Title Annualized Rate of Clinical Asthma Exacerbations (CAEs)
    Description Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.
    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Mean (Standard Deviation) [CAEs / year]
    0.42
    (1.104)
    0.70
    (1.538)
    7. Secondary Outcome
    Title Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits
    Description Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Annual rate is defined as the number of events/(duration of treatment [days]/365.25). Participants with zero events are included.
    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Mean (Standard Deviation) [CAEs / year]
    0.06
    (0.362)
    0.11
    (0.514)
    8. Secondary Outcome
    Title Mean Number of Days of Hospital Stay During the Treatment Period
    Description Participants with no hospitalizations are included.
    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Mean (Standard Deviation) [days]
    0.25
    (1.658)
    1.02
    (7.848)
    9. Secondary Outcome
    Title Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period
    Description Participants with no school or work days missed due to asthma are included in the counts.
    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Mean (Standard Deviation) [days]
    0.11
    (1.202)
    0.00
    (0.000)
    10. Secondary Outcome
    Title Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
    Description The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters. Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule.
    Time Frame Week 0 (baseline), Weeks 8, 24, 36

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Baseline - observed value
    2.162
    (0.980)
    2.117
    (0.927)
    Change at Week 8
    0.099
    (0.704)
    0.031
    (0.529)
    Change at Week 24
    0.169
    (0.851)
    -0.020
    (0.472)
    Change at Week 36
    0.245
    (0.677)
    0.010
    (0.550)
    11. Secondary Outcome
    Title Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
    Description A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.
    Time Frame Week 0 (baseline), Weeks 1, 4, 8, 24, 36

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Baseline - observed value
    2.057
    (0.814)
    2.027
    (0.847)
    Change at Week 1
    0.002
    (0.345)
    -0.044
    (0.291)
    Change at Week 4
    0.051
    (0.490)
    -0.049
    (0.319)
    Change at Week 8
    0.028
    (0.463)
    -0.039
    (0.345)
    Change at Week 24
    0.051
    (0.492)
    -0.062
    (0.403)
    Change at Week 36
    0.061
    (0.273)
    -0.053
    (0.465)
    12. Secondary Outcome
    Title Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36
    Description Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose. Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range. Percent change = 100 * (absolute change / baseline dose)
    Time Frame Week 0 (baseline), Weeks 16-20, Weeks 32-36

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set of participants on daily OCS at baseline
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 46 45
    % change at Week 16-20
    -2.19
    (51.347)
    -6.96
    (40.904)
    % change at Week 32-36
    -8.44
    (24.236)
    -8.75
    (29.666)
    13. Secondary Outcome
    Title Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36
    Description Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages. The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.
    Time Frame Baseline (Week 0), Weeks 1, 4, 8, 24, 36

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Baseline - observed values
    2.4
    (3.39)
    2.6
    (3.10)
    Change at Week 1
    -0.4
    (1.30)
    -0.4
    (1.17)
    Change at Week 4
    -0.6
    (1.86)
    -0.5
    (1.50)
    Change at Week 8
    -0.7
    (1.79)
    -0.6
    (1.61)
    Change at Week 24
    -0.8
    (1.92)
    -0.8
    (1.78)
    Change at Week 36
    -0.5
    (1.69)
    -0.6
    (1.80)
    14. Secondary Outcome
    Title Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
    Description The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.
    Time Frame Baseline (Week 0), Weeks 8, 24, 36

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Baseline - observed values
    1.72
    (1.098)
    1.69
    (1.171)
    Change at Week 8
    -0.31
    (0.777)
    -0.20
    (0.718)
    Change at Week 24
    -0.30
    (0.936)
    -0.23
    (0.771)
    Change at Week 36
    -0.34
    (0.855)
    -0.28
    (0.867)
    15. Secondary Outcome
    Title Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36
    Description The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates "total impairment") to 7 (indicates "no impairment"). Positive change from baseline values indicate improved quality of life.
    Time Frame Baseline (Week 0), Weeks 8, 24, 36

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set of participants age 12-70 years
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 187 179
    Baseline - observed value
    5.04
    (1.249)
    5.14
    (1.270)
    Change at Week 8
    0.30
    (0.716)
    0.14
    (0.700)
    Change at Week 24
    0.28
    (0.727)
    0.20
    (0.830)
    Change at Week 36
    0.32
    (0.835)
    0.19
    (0.948)
    16. Secondary Outcome
    Title Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
    Description Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample. Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb). The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.
    Time Frame Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 194 196
    Count of Participants [Participants]
    11
    5.7%
    9
    4.6%
    17. Secondary Outcome
    Title Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)
    Description The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.
    Time Frame Week 51

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set
    Arm/Group Title Reslizumab 110 mg; Previous Treatment Placebo Reslizumab 110 mg; Previous Treatment Reslizumab
    Arm/Group Description Participants who were administered placebo in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses. Participants who were administered reslizumab in the parent study, were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    Measure Participants 0 0

    Adverse Events

    Time Frame Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.
    Adverse Event Reporting Description
    Arm/Group Title Reslizumab 110 mg
    Arm/Group Description Participants were administered reslizumab 110 mg by subcutaneous injection every 4 weeks for a total of 9 doses.
    All Cause Mortality
    Reslizumab 110 mg
    Affected / at Risk (%) # Events
    Total 0/390 (0%)
    Serious Adverse Events
    Reslizumab 110 mg
    Affected / at Risk (%) # Events
    Total 16/390 (4.1%)
    Gastrointestinal disorders
    Abdominal distension 1/390 (0.3%) 1
    Dysphagia 1/390 (0.3%) 1
    Inguinal hernia 1/390 (0.3%) 1
    Vomiting 1/390 (0.3%) 1
    General disorders
    Chest pain 1/390 (0.3%) 1
    Infections and infestations
    Appendicitis 1/390 (0.3%) 1
    Influenza 1/390 (0.3%) 1
    Peritonsillar abscess 1/390 (0.3%) 1
    Pneumonia 3/390 (0.8%) 3
    Injury, poisoning and procedural complications
    Post procedural haematoma 1/390 (0.3%) 1
    Musculoskeletal and connective tissue disorders
    Neck pain 1/390 (0.3%) 1
    Osteoarthritis 1/390 (0.3%) 1
    Synovial cyst 1/390 (0.3%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/390 (0.3%) 1
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 1/390 (0.3%) 1
    Renal and urinary disorders
    Nephrolithiasis 1/390 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 2/390 (0.5%) 2
    Vascular disorders
    Hypertensive crisis 1/390 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    Reslizumab 110 mg
    Affected / at Risk (%) # Events
    Total 70/390 (17.9%)
    Infections and infestations
    Upper respiratory tract infection 23/390 (5.9%) 24
    Viral upper respiratory tract infection 49/390 (12.6%) 62

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.

    Results Point of Contact

    Name/Title Director, Clinical Research
    Organization Teva Branded Pharmaceutical Products, R&D Inc.
    Phone 1-888-483-8279
    Email USMedInfo@tevapharm.com
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT03052725
    Other Study ID Numbers:
    • C38072-AS-30066
    • 2016-004661-23
    First Posted:
    Feb 14, 2017
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021