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An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT02501629
First received: July 14, 2015
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
The primary objective of the study is to determine the ability of reslizumab administered sc to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.

Condition Intervention Phase
Asthma Elevated Blood Eosinophils Drug: Reslizumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:
  • Percent reduction in daily OCS dose compared with baseline [ Time Frame: Week 0 through study week 24 ]

Secondary Outcome Measures:
  • Proportion of patients achieving ≥50% reduction in OCS dose [ Time Frame: Week 0 through study week 24 ]
  • Proportion of patients achieving OCS dose reduction to ≤5mg daily dose [ Time Frame: Week 0 through study week 24 ]
  • Percent change from baseline in OCS dose [ Time Frame: Week 0 through study week 24 ]
  • Proportion of patients achieving less than 5 mg decrement in OCS dose compared to the baseline OCS dose [ Time Frame: Week 0 through study week 24 ]
  • Annualized rate of clinical asthma exacerbations [ Time Frame: Week 0 through study week 24 ]
    Annualized rate of clinical asthma exacerbations requiring a burst of systemic corticosteroid (injection, or if oral, at least a doubling from the current OCS dose for at least 3 days); an asthma-specific hospital admission; or an asthma-specific emergency department visit

  • Proportion of patients discontinuing OCS [ Time Frame: Week 0 through study week 24 ]
  • Time to first clinical asthma exacerbation [ Time Frame: Week 0 through study week 24 ]
  • Pre-bronchodilator FEV1: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • Post-bronchodilator FEV1: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • Ambulatory lung function: change in peak expiratory flow (PEF) from run-in baseline [ Time Frame: Week 0 through study week 24 ]
  • Asthma Quality of Life (AQLQ) + 12 score: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • ACQ-6: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • Change in nighttime awakenings due to asthma requiring rescue inhaler from run-in baseline [ Time Frame: Week 0 through study week 24 ]
  • Change in total asthma symptom scores from run-in baseline [ Time Frame: Week 0 through study week 24 ]
  • European Quality of Life 5-dimension health state utility index (EQ-5D) score: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • St. George's Respiratory Questionnaire (SGRQ) score: change from baseline [ Time Frame: Week 0 through study week 24 ]
  • Change in total rescue inhaler use from run-in baseline [ Time Frame: Week 0 through study week 24 ]
  • Serum response relationships [ Time Frame: Week 0 through study week 24 ]
    Serum reslizumab concentrations to characterize PK and assess exposure response relationships

  • Immunogenicity as assessed by anti-drug antibodies (ADA) [ Time Frame: Week 0 through study week 48 ]
  • Percentage of participants with adverse events [ Time Frame: Week 0 through study week 32 ]

Enrollment: 177
Study Start Date: September 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reslizumab
Reslizumab Subcutaneous Dosing
Drug: Reslizumab
Reslizumab Subcutaneous Dosing
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
  2. Written informed consent is obtained.
  3. The patient requires daily maintenance dose of prednisone or equivalent for asthma of between 5 and 40 mg during the 3 months prior to screening.
  4. The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
  5. The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
  6. The patient has FEV1 reversibility to inhaled SABA or historical reversibility within the previous 24 months.

    • Other criteria may apply, please contact the investigator for more information.

Exclusion Criteria:

  1. The patient has any clinically significant, uncontrolled medical condition that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient's safety.
  2. The patient has another confounding underlying lung disorder.
  3. The patient has a known hypereosinophilic syndrome.
  4. The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
  5. The patient is pregnant or intends to become pregnant during the study or is lactating.
  6. The patient required treatment for an asthma exacerbation within 4 weeks of screening.
  7. The patient is a current smoker or has a smoking history ≥10 pack-years.
  8. The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
  9. The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
  10. The patient was previously exposed to benralizumab within 12 months of screening.
  11. The patient was previously exposed to reslizumab.
  12. The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
  13. The patient has current suspected drug and/or alcohol abuse.
  14. The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
  15. The patient has a history of allergic reactions or hypersensitivity to any component of the study drug.

    • Other criteria may apply, please contact the investigator for more information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02501629

  Hide Study Locations
Locations
United States, California
Teva Investigational Site 13357
Bakersfield, California, United States
Teva Investigational Site 13376
Walnut Creek, California, United States
United States, Florida
Teva Investigational Site 13371
Clermont, Florida, United States
Teva Investigational Site 13351
Homestead, Florida, United States
Teva Investigational Site 13344
Miami, Florida, United States
Teva Investigational Site 13354
Pembroke Pines, Florida, United States
Teva Investigational Site 13368
Sebring, Florida, United States
Teva Investigational Site 13346
Tampa, Florida, United States
United States, Illinois
Teva Investigational Site 13367
Chicago, Illinois, United States
United States, Indiana
Teva Investigational Site 13345
Michigan City, Indiana, United States
United States, Kansas
Teva Investigational Site 13348
Lenexa, Kansas, United States
United States, Mississippi
Teva Investigational Site 13362
Biloxi, Mississippi, United States
United States, Missouri
Teva Investigational Site 13350
Saint Louis, Missouri, United States
United States, New York
Teva Investigational Site 13356
New York, New York, United States
United States, Ohio
Teva Investigational Site 13349
Cincinnati, Ohio, United States
United States, Oklahoma
Teva Investigational Site 13370
Edmond, Oklahoma, United States
Teva Investigational Site 13347
Oklahoma City, Oklahoma, United States
United States, South Carolina
Teva Investigational Site 13366
Charleston, South Carolina, United States
United States, Texas
Teva Investigational Site 13377
Dallas, Texas, United States
Teva Investigational Site 13369
Houston, Texas, United States
United States, Virginia
Teva Investigational Site 13358
Fairfax, Virginia, United States
Argentina
Teva Investigational Site 20056
Buenos Aires, Argentina
Teva Investigational Site 20057
Buenos Aires, Argentina
Teva Investigational Site 20058
Buenos Aires, Argentina
Teva Investigational Site 20059
Buenos Aires, Argentina
Teva Investigational Site 20052
Cordoba, Argentina
Teva Investigational Site 20050
Mendoza, Mendoza City, Argentina
Teva Investigational Site 20055
Mendoza, Argentina
Teva Investigational Site 20087
Rosario, Argentina
Teva Investigational Site 20051
San Miguel de Tucuman, Argentina
Teva Investigational Site 20066
San Rafael, Argentina
Australia
Teva Investigational Site 78089
Bedford Park, Australia
Teva Investigational Site 78097
Frankston, Australia
Teva Investigational Site 78093
South Australia, Australia
Belgium
Teva Investigational Site 37059
Bruxelles, Belgium
Teva Investigational Site 37058
Gembloux, Belgium
Czech Republic
Teva Investigational Site 54133
Breclav, Czech Republic
Teva Investigational Site 54132
Jindrichuv Hradec, Czech Republic
France
Teva Investigational Site 35186
Le Kremlin-bicetre, France
Teva Investigational Site 35185
Lille Cedex, France
Teva Investigational Site 35189
Lyon Cedex 04, France
Teva Investigational Site 35187
Strasbourg, France
Germany
Teva Investigational Site 32621
Bad Worishofen, Germany
Teva Investigational Site 32573
Berlin, Germany
Teva Investigational Site 32576
Berlin, Germany
Teva Investigational Site 32578
Berlin, Germany
Teva Investigational Site 32622
Frankfurt, Germany
Teva Investigational Site 32579
Hannover, Germany
Teva Investigational Site 32574
Leipzig, Germany
Teva Investigational Site 32580
Rostock, Germany
Hungary
Teva Investigational Site 51254
Csorna, Hungary
Teva Investigational Site 51253
Szombathely, Hungary
Israel
Teva Investigational Site 80085
Haifa, Israel
Teva Investigational Site 80083
Jerusalem, Israel
Teva Investigational Site 80091
Kfar Saba, Israel
Teva Investigational Site 80084
Petah Tikva, Israel
Teva Investigational Site 80082
Rehovot, Israel
Italy
Teva Investigational Site 30152
Catanzaro, Italy
Korea, Republic of
Teva Investigational Site 87024
Jeonju, Korea, Republic of
Teva Investigational Site 87021
Seoul, Korea, Republic of
Teva Investigational Site 87023
Seoul, Korea, Republic of
Mexico
Teva Investigational Site 21106
Chihuahua, Mexico
Teva Investigational Site 21102
Distrito Federal, Mexico
Teva Investigational Site 21104
Durango, Mexico
Teva Investigational Site 21094
Guadalajara, JAL, Mexico
Teva Investigational Site 21091
Guadalajara, Mexico
Teva Investigational Site 21093
Guadalajara, Mexico
Teva Investigational Site 21100
Guadalajara, Mexico
Teva Investigational Site 21101
Monterrey, Mexico
Teva Investigational Site 21103
Monterrey, Mexico
Teva Investigational Site 21105
Querétaro, Mexico
Netherlands
Teva Investigational Site 38084
Leeuwarden, Netherlands
Teva Investigational Site 38085
Zwolle, Netherlands
Poland
Teva Investigational Site 53316
Gdansk, Poland
Teva Investigational Site 53318
Krakow, Poland
Teva Investigational Site 53319
Lodz, Poland
Teva Investigational Site 53321
Lodz, Poland
Teva Investigational Site 53322
Lubin, Poland
Teva Investigational Site 53320
Ostrow Wielkopolski, Poland
Teva Investigational Site 53358
Rzeszow, Poland
Teva Investigational Site 53317
Tarnow, Poland
Teva Investigational Site 53323
Wroclaw, Poland
Russian Federation
Teva Investigational Site 50356
Barnaul, Russian Federation
Teva Investigational Site 50417
Chelyabinsk, Russian Federation
Teva Investigational Site 50419
Ekaterinburg, Russian Federation
Teva Investigational Site 50382
Kemerovo, Russian Federation
Teva Investigational Site 50385
Kemerovo, Russian Federation
Teva Investigational Site 50384
Moscow, Russian Federation
Teva Investigational Site 50383
Novosibirsk, Russian Federation
Teva Investigational Site 50357
St. Petersburg, Russian Federation
Teva Investigational Site 50358
Tomsk, Russian Federation
Teva Investigational Site 50418
Tomsk, Russian Federation
Spain
Teva Investigational Site 31159
Barcelona, Spain
Teva Investigational Site 31161
Girona, Spain
Teva Investigational Site 31158
Valencia, Spain
Teva Investigational Site 31160
Valencia, Spain
Ukraine
Teva Investigational Site 58245
Dnepropetrovsk, Ukraine
Teva Investigational Site 58238
Dnipropetrovsk, Ukraine
Teva Investigational Site 58240
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58235
Kharkiv, Ukraine
Teva Investigational Site 58239
Kharkiv, Ukraine
Teva Investigational Site 58241
Kharkiv, Ukraine
Teva Investigational Site 58244
Kharkiv, Ukraine
Teva Investigational Site 58249
Kremenchuk, Ukraine
Teva Investigational Site 58237
Kyiv, Ukraine
Teva Investigational Site 58248
Kyiv, Ukraine
Teva Investigational Site 58250
Kyiv, Ukraine
Teva Investigational Site 58251
Kyiv, Ukraine
Teva Investigational Site 58243
Sumy, Ukraine
Teva Investigational Site 58246
Vinnytsya, Ukraine
Teva Investigational Site 58242
Zhaporizhzhya, Ukraine
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02501629     History of Changes
Other Study ID Numbers: C38072-AS-30027
2015-001580-39 ( EudraCT Number )
Study First Received: July 14, 2015
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 14, 2017