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:
Teva Branded Pharmaceutical Products, R&D Inc.
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
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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:
- The patient is male or female, 12 years of age and older, with a previous diagnosis of asthma.
- Written informed consent is obtained.
- 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.
- The patient has a documented elevated blood eosinophils at screening or during the previous 12 months.
- The patient has required high dose ICS plus another asthma controller for at least 6 months prior to screening.
-
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:
- 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.
- The patient has another confounding underlying lung disorder.
- The patient has a known hypereosinophilic syndrome.
- The patient has a history of any malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
- The patient is pregnant or intends to become pregnant during the study or is lactating.
- The patient required treatment for an asthma exacerbation within 4 weeks of screening.
- The patient is a current smoker or has a smoking history ≥10 pack-years.
- The patient is currently using any systemic immunosuppressive or immunomodulatory biologic except maintenance OCS for the treatment of asthma.
- The patient participated in a clinical study within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
- The patient was previously exposed to benralizumab within 12 months of screening.
- The patient was previously exposed to reslizumab.
- The patient has a history of immunodeficiency disorder including human immunodeficiency virus.
- The patient has current suspected drug and/or alcohol abuse.
- The patient has had an active helminthic parasitic infection or was treated for one within 6 months of screening.
-
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02501629
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02501629
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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


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