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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01270464
Other study ID # C38072/3081
Secondary ID 2010-023342-67
Status Completed
Phase Phase 3
First received December 29, 2010
Last updated May 23, 2014
Start date December 2010
Est. completion date December 2013

Study information

Verified date May 2014
Source Teva Pharmaceutical Industries
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Ministry of HealthBrazil: Ministry of HealthCanada: Health CanadaColombia: National Institutes of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyIsrael: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Ministry of HealthRomania: National Medicines AgencySweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 75 Years
Eligibility 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 Argentina.

- The patient has an ACQ score of at least 1.5.

- The patient has airway reversibility of at least 12% to beta-agonist administration at screening.

- The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout study.

- The patient has a blood eosinophil count of at least 400/µL.

- Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ßHCG 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 the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).

- Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.

- Other inclusion criteria apply.

Exclusion Criteria:

- The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.

- The patient has known hypereosinophilic syndrome (HES).

- The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).

- The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).

- The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-a, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening).

- The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).

- The patient has a current infection or disease that may preclude assessment of asthma.

- The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.

- The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).

- 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 90 days prior to screening.

- The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).

- Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.

- The patient has a current infection or disease that may preclude assessment of asthma.

- The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.

- Other exclusion criteria apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Reslizumab
0.3 mg/kg, 3.0 mg/kg
Placebo
Matching placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Locations

Country Name City State
Argentina Teva Investigational Site 121 Ciudad Autonoma de Buenos Aire
Argentina Teva Investigational Site 126 Ciudad Autonoma de Buenos Aire
Argentina Teva Investigational Site 127 Ciudad Autonoma de Buenos Aire
Argentina Teva Investigational Site 128 Quilmes-Buenos Aires
Argentina Teva Investigational Site 125 Rosario
Argentina Teva Investigational Site 123 Rosario-Santa Fe
Argentina Teva Investigational Site 120 San Miguel de Tucuman - Tucuma
Argentina Teva Investigational Site 122 San Miguel de Tucuman - Tucuma
Argentina Teva Investigational Site 124 San Miguel de Tucuman - Tucuma
Belgium Teva Investigational Site 261 Bruxelles
Belgium Teva Investigational Site 264 Bruxelles
Belgium Teva Investigational Site 260 Gent
Belgium Teva Investigational Site 263 Liège
Brazil Teva Investigational Site 146 Belo Horizonte
Brazil Teva Investigational Site 150 Florianopolis
Brazil Teva Investigational Site 140 Porto Alegre
Brazil Teva Investigational Site 143 Porto Alegre
Brazil Teva Investigational Site 144 Porto Alegre
Brazil Teva Investigational Site 145 Porto Alegre
Brazil Teva Investigational Site 147 Porto Alegre - RS
Brazil Teva Investigational Site 142 Santo André, São Paulo
Brazil Teva Investigational Site 141 Sao Paulo
Canada Teva Investigational Site 103 Calgary
Canada Teva Investigational Site 101 Montreal
Canada Teva Investigational Site 104 Newmarket
Canada Teva Investigational Site 105 Windsor
Colombia Teva Investigational Site 184 Bogota
Colombia Teva Investigational Site 185 Bogota
Colombia Teva Investigational Site 181 Bogotá
Colombia Teva Investigational Site 182 Cali
Colombia Teva Investigational Site 180 Floridablanca
Colombia Teva Investigational Site 183 Medellin
France Teva Investigational Site 343 Grenoble
France Teva Investigational Site 342 Marseille
France Teva Investigational Site 341 Montpellier
France Teva Investigational Site 340 Nantes
France Teva Investigational Site 344 Pessac
Hungary Teva Investigational Site 401 Balassagyarmat
Hungary Teva Investigational Site 406 Edelény
Hungary Teva Investigational Site 400 Miskolc
Hungary Teva Investigational Site 404 Mosonmagyaróvár
Hungary Teva Investigational Site 403 Sopron
Hungary Teva Investigational Site 407 Százhalombatta
Hungary Teva Investigational Site 402 Tatabánya
Israel Teva Investigational Site 422 Petach Tikva
Israel Teva Investigational Site 421 Rehovot
Israel Teva Investigational Site 420 Tel-Aviv
Mexico Teva Investigational Site 203 Distrito Federal
Mexico Teva Investigational Site 205 Distrito Federal
Mexico Teva Investigational Site 204 Guadalajara, JAL
Mexico Teva Investigational Site 200 Hermosillo, Sonora
Mexico Teva Investigational Site 202 Tijuana, B.C.
Netherlands Teva Investigational Site 460 Heerlen
Poland Teva Investigational Site 507 Bialystok
Poland Teva Investigational Site 513 Gdansk
Poland Teva Investigational Site 512 Lodz
Poland Teva Investigational Site 505 Lublin
Poland Teva Investigational Site 500 Ostrow Wielkopolski
Poland Teva Investigational Site 502 Sopot
Poland Teva Investigational Site 504 Tarnow
Sweden Teva Investigational Site 602 Göteborg
Sweden Teva Investigational Site 600 Lund
Sweden Teva Investigational Site 601 Malmö
United States Teva Investigational Site 12 Anaheim California
United States Teva Investigational Site 21 Charleston South Carolina
United States Teva Investigational Site 20 Cincinnati Ohio
United States Teva Investigational Site 2 Colorado Springs Colorado
United States Teva Investigational Site 16 Fort Worth Texas
United States Teva Investigational Site 11 Fountain Valley California
United States Teva Investigational Site 10 Houston Texas
United States Teva Investigational Site 7 Iowa City Iowa
United States Teva Investigational Site 24 Largo Florida
United States Teva Investigational Site 6 Lilburn Georgia
United States Teva Investigational Site 73 Lincoln Rhode Island
United States Teva Investigational Site 43 Los Angeles California
United States Teva Investigational Site 1 Medford Oregon
United States Teva Investigational Site 27 Miami Florida
United States Teva Investigational Site 5 Miami Florida
United States Teva Investigational Site 8 Omaha Nebraska
United States Teva Investigational Site 4 Orange California
United States Teva Investigational Site 9 Providence Rhode Island
United States Teva Investigational Site 14 San Antonio Texas
United States Teva Investigational Site 45 San Antonio Texas
United States Teva Investigational Site 3 Savannah Georgia
United States Teva Investigational Site 26 Summit New Jersey
United States Teva Investigational Site 19 Tallahassee Florida
United States Teva Investigational Site 17 Trinity Florida
United States Teva Investigational Site 18 Valrico Florida
United States Teva Investigational Site 15 Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Colombia,  France,  Hungary,  Israel,  Mexico,  Netherlands,  Poland,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall change from baseline as assessed by Forced Expiratory Volume in 1 second (FEV1) baseline to week 16 (or early withdrawal) baseline to week 16 No
Secondary Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (% predicted FEV1) from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Lung function as measured by Forced Vital Capacity (FVC) from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Lung function as measured by Forced Expiratory Flow at 25% to 75% of FVC (FEF25-75%) from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Short-acting beta-agonist use from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Blood eosinophil count from baseline to weeks 4, 8, 12, 16 and follow-up or early withdrawal baseline to week 16 No
Secondary Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI) from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Asthma control as measured by the Asthma Control Questionnaire (ACQ) from baseline to weeks 4, 8, 12, 16 or early withdrawal baseline to week 16 No
Secondary Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) from baseline to week 16 or early withdrawal baseline to week 16 No
Secondary Evaluate the safety and tolerability of reslizumab treatment 16 weeks + 90 day follow-up:
occurrence of adverse events
clinical laboratory test results
vital signs (blood pressures, pulse, body temperature, and respiratory rate) measurements at weeks 4, 8, 12, and 16 or early withdrawal and 90 (±7) days after the end-of treatment evaluation.
physical examination findings, including body weight measurements, at weeks 4, 8, 12, and 16 or early withdrawal
12-lead electrocardiography (ECG) findings at week 16 or early withdrawal
concomitant medication usage throughout the study
7 months Yes
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