Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Eosinophilic Asthma Clinical Trial

Official title:

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01290887
• Other study ID #: C38072/3085
• Secondary ID: 2010-024540-15
• Status: Terminated
• Phase: Phase 3
• First received: February 4, 2011
• Last updated: October 21, 2015
• Start date: June 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelarus: Ministry of HealthBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: Ministry of HealthCanada: Health CanadaChile: Ministry of HealthColombia: National Institutes of HealthCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthGreece: Ministry of Health and WelfareHungary: National Institute of PharmacyIndia: Ministry of HealthIsrael: Israeli Health Ministry Pharmaceutical AdministrationMalaysia: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)New Zealand: Ministry of HealthNorway: Norwegian Medicines AgencyPeru: Ministry of HealthPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Sweden: Medical Products AgencyThailand: Food and Drug AdministrationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

Description:

Study patients were deemed eligible based on activities from the preceding Teva sponsored double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion criterion c, patients must have either completed treatment in a previous Teva-sponsored study or have received at least 2 doses of study drug treatment in a pulmonary function study.

Eligible patients could enroll in this study only after completion of the end of treatment visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab in eosinophilic asthma, which served as the screening/baseline visit for participation in this open label extension study. The use of systemic corticosteroids for asthma in any of the previous Teva sponsored double blind studies of reslizumab did not exclude patients from this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082 (NCT01287039), and C38072/3083 (NCT01285323).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1052
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• Written informed consent is obtained.

• Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.

• The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

• other criteria may apply; please contact the investigator for more information.

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 another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).

• The patient is a current smoker.

• 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 (e.g., gastroesophageal reflux disease [GERD]).

• Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.

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

• other criteria may apply; please contact the investigator for more information.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Eosinophilic Asthma
• Pulmonary Eosinophilia

Intervention

Drug:
• Reslizumab
Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

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
Australia	Teva Investigational Site 641	East Bentleigh
Australia	Teva Investigational Site 642	Frankston
Australia	Teva Investigational Site 645	Liverpool
Australia	Teva Investigational Site 643	Nedlands
Belgium	Teva Investigational Site 261	Bruxelles
Belgium	Teva Investigational Site 264	Bruxelles
Belgium	Teva Investigational Site 260	Gent
Belgium	Teva Investigational Site 262	Jambes
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 144	Porto Alegre
Brazil	Teva Investigational Site 147	Porto Alegre - RS
Brazil	Teva Investigational Site 143	Porto Alegre, RS
Brazil	Teva Investigational Site 142	Santo André, São 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
Chile	Teva Investigational Site 160	Rancagua
Chile	Teva Investigational Site 164	Santiago
Chile	Teva Investigational Site 161	Temuco
Chile	Teva Investigational Site 162	Valdivia
Chile	Teva Investigational Site 166	Valparaiso
Colombia	Teva Investigational Site 185	Bogota
Colombia	Teva Investigational Site 181	Bogotá
Colombia	Teva Investigational Site 182	Cali
Colombia	Teva Investigational Site 180	Floridablanca
Czech Republic	Teva Investigational Site 284	Breclav
Czech Republic	Teva Investigational Site 287	Brno
Czech Republic	Teva Investigational Site 286	Liberec
Czech Republic	Teva Investigational Site 280	Olomouc
Czech Republic	Teva Investigational Site 281	Olomouc
Czech Republic	Teva Investigational Site 285	Olomouc
Czech Republic	Teva Investigational Site 283	Tabor
Denmark	Teva Investigational Site 300	Odense
France	Teva Investigational Site 342	Marseille
France	Teva Investigational Site 341	Montpellier
Germany	Teva Investigational Site 361	Berlin
Germany	Teva Investigational Site 366	Berlin
Germany	Teva Investigational Site 371	Bochum
Germany	Teva Investigational Site 369	Frankfurt
Germany	Teva Investigational Site 370	Hamburg
Germany	Teva Investigational Site 372	Koblenz
Germany	Teva Investigational Site 367	Leipzig
Germany	Teva Investigational Site 363	Mainz
Greece	Teva Investigational Site 380	Athens
Hungary	Teva Investigational Site 401	Balassagyarmat
Hungary	Teva Investigational Site 400	Miskolc
Hungary	Teva Investigational Site 404	Mosonmagyaróvár
Hungary	Teva Investigational Site 403	Sopron
Hungary	Teva Investigational Site 407	Szazhalombatta
Hungary	Teva Investigational Site 402	Tatabánya
Hungary	Teva Investigational Site 405	Törökbálint
Israel	Teva Investigational Site 423	Ashkelon
Israel	Teva Investigational Site 432	Haifa
Israel	Teva Investigational Site 425	Jerusalem
Israel	Teva Investigational Site 428	Jerusalem
Israel	Teva Investigational Site 426	Kfar Saba
Israel	Teva Investigational Site 422	Petach Tikva
Israel	Teva Investigational Site 433	Ramat Gan
Israel	Teva Investigational Site 421	Rehovot
Israel	Teva Investigational Site 420	Tel-Aviv
Korea, Republic of	Teva Investigational Site 682	Gwangju
Korea, Republic of	Teva Investigational Site 680	Seoul
Korea, Republic of	Teva Investigational Site 681	Seoul
Korea, Republic of	Teva Investigational Site 683	Seoul
Korea, Republic of	Teva Investigational Site 686	Seoul
Korea, Republic of	Teva Investigational Site 685	Suwon
Malaysia	Teva Investigational Site 705	Batu Caves
Malaysia	Teva Investigational Site 700	Kuala Lumpur
Malaysia	Teva Investigational Site 702	Kuala Lumpur
Malaysia	Teva Investigational Site 701	Penang
Malaysia	Teva Investigational Site 704	Taiping
Mexico	Teva Investigational Site 205	Ciudad De México
Mexico	Teva Investigational Site 203	Distrito Federal
Mexico	Teva Investigational Site 204	Guadalajara, JAL
Mexico	Teva Investigational Site 200	Hermosillo, Sonora
Mexico	Teva Investigational Site 207	Mexico City
Mexico	Teva Investigational Site 209	Monterrey
Mexico	Teva Investigational Site 202	Tijuana, B.C.
Netherlands	Teva Investigational Site 460	Heerlen
New Zealand	Teva Investigational Site 723	Auckland
New Zealand	Teva Investigational Site 724	Dunedin
New Zealand	Teva Investigational Site 727	Hamilton
New Zealand	Teva Investigational Site 720	Tauranga
New Zealand	Teva Investigational Site 721	Wellington
Peru	Teva Investigational Site 223	Cercado de Lima, Lima
Peru	Teva Investigational Site 220	Lima
Peru	Teva Investigational Site 221	Lima
Peru	Teva Investigational Site 222	Lima
Peru	Teva Investigational Site 225	Lima
Peru	Teva Investigational Site 226	Lima
Peru	Teva Investigational Site 227	Lima
Peru	Teva Investigational Site 229	Lima
Philippines	Teva Investigational Site 742	Manila
Philippines	Teva Investigational Site 740	Quezon City
Philippines	Teva Investigational Site 741	Quezon City
Philippines	Teva Investigational Site 743	Quezon City
Philippines	Teva Investigational Site 745	Quezon City
Poland	Teva Investigational Site 507	Bialystok
Poland	Teva Investigational Site 509	Bydgoszcz
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 511	Poznan
Poland	Teva Investigational Site 504	Tarnow
Romania	Teva Investigational Site 523	Bucharest
Romania	Teva Investigational Site 524	Bucharest
Romania	Teva Investigational Site 520	Cluj-Napoca
Romania	Teva Investigational Site 521	Iasi
Romania	Teva Investigational Site 522	Targu Mures
Russian Federation	Teva Investigational Site 545	Barnaul
Russian Federation	Teva Investigational Site 549	Kemerovo
Russian Federation	Teva Investigational Site 543	Moscow
Russian Federation	Teva Investigational Site 544	Moscow
Russian Federation	Teva Investigational Site 554	Moscow
Russian Federation	Teva Investigational Site 558	Moscow
Russian Federation	Teva Investigational Site 559	Moscow
Russian Federation	Teva Investigational Site 555	Novosibirsk
Russian Federation	Teva Investigational Site 557	Novosibirsk
Russian Federation	Teva Investigational Site 541	St. Petersburg
Russian Federation	Teva Investigational Site 542	St. Petersburg
Russian Federation	Teva Investigational Site 540	St.Petersburg
Russian Federation	Teva Investigational Site 552	Tomsk
Russian Federation	Teva Investigational Site 546	Yaroslavl
Slovakia	Teva Investigational Site 563	Bradejov
Slovakia	Teva Investigational Site 561	Levice
Slovakia	Teva Investigational Site 560	Spisska Nova Ves
Slovakia	Teva Investigational Site 562	Topolcany
South Africa	Teva Investigational Site 584	Cape Town
South Africa	Teva Investigational Site 586	Cape Town
South Africa	Teva Investigational Site 587	Centurion
South Africa	Teva Investigational Site 582	Durban
South Africa	Teva Investigational Site 585	Durban
South Africa	Teva Investigational Site 580	Johannesburg
South Africa	Teva Investigational Site 589	Johannesburg
South Africa	Teva Investigational Site 583	Pretoria
South Africa	Teva Investigational Site 588	Pretoria
Sweden	Teva Investigational Site 602	Göteborg
Sweden	Teva Investigational Site 604	Göteborg
Sweden	Teva Investigational Site 603	Linköping
Sweden	Teva Investigational Site 600	Lund
Sweden	Teva Investigational Site 601	Malmö
Taiwan	Teva Investigational Site 761	Taipei
Taiwan	Teva Investigational Site 763	Taoyuan
Thailand	Teva Investigational Site 780	Bangkok
Thailand	Teva Investigational Site 782	Bangkok
Thailand	Teva Investigational Site 784	Nakhon Ratchasima
Ukraine	Teva Investigational Site 621	Dnipropetrovsk
Ukraine	Teva Investigational Site 629	Donetsk
Ukraine	Teva Investigational Site 630	Ivano-Frankivsk
Ukraine	Teva Investigational Site 620	Kharkiv
Ukraine	Teva Investigational Site 633	Kharkiv
Ukraine	Teva Investigational Site 622	Kyiv
Ukraine	Teva Investigational Site 623	Kyiv
Ukraine	Teva Investigational Site 624	Kyiv
Ukraine	Teva Investigational Site 625	Kyiv
Ukraine	Teva Investigational Site 626	Vinnytsya
Ukraine	Teva Investigational Site 631	Zaporizhzhia
Ukraine	Teva Investigational Site 632	Zaporizhzhya
United States	Teva Investigational Site 66	Altoona	Pennsylvania
United States	Teva Investigational Site 12	Anaheim	California
United States	Teva Investigational Site 46	Bangor	Maine
United States	Teva Investigational Site 63	Boerne	Texas
United States	Teva Investigational Site 64	Boys Town	Nebraska
United States	Teva Investigational Site 21	Charleston	South Carolina
United States	Teva Investigational Site 20	Cincinnati	Ohio
United States	Teva Investigational Site 31	Cincinnati	Ohio
United States	Teva Investigational Site 53	Clearwater	Florida
United States	Teva Investigational Site 2	Colorado Springs	Colorado
United States	Teva Investigational Site 34	Colorado Springs	Colorado
United States	Teva Investigational Site 44	Dallas	Texas
United States	Teva Investigational Site 47	Denver	Colorado
United States	Teva Investigational Site 69	El Paso	Texas
United States	Teva Investigational Site 16	Fort Worth	Texas
United States	Teva Investigational Site 11	Fountain Valley	California
United States	Teva Investigational Site 41	Fresno	California
United States	Teva Investigational Site 24	Largo	Florida
United States	Teva Investigational Site 25	Lawrenceville	Georgia
United States	Teva Investigational Site 49	Lexington	Kentucky
United States	Teva Investigational Site 6	Lilburn	Georgia
United States	Teva Investigational Site 73	Lincoln	Rhode Island
United States	Teva Investigational Site 59	Long Beach	California
United States	Teva Investigational Site 43	Los Angeles	California
United States	Teva Investigational Site 33	Madison	Wisconsin
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 55	Miami	Florida
United States	Teva Investigational Site 32	Nashville	Tennessee
United States	Teva Investigational Site 50	Oklahoma City	Oklahoma
United States	Teva Investigational Site 8	Omaha	Nebraska
United States	Teva Investigational Site 4	Orange	California
United States	Teva Investigational Site 52	Orlando	Florida
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 58	Scottsdale	Arizona
United States	Teva Investigational Site 40	St. Louis	Missouri
United States	Teva Investigational Site 74	St. Louis	Missouri
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
United States	Teva Investigational Site 28	Waterbury	Connecticut
United States	Teva Investigational Site 30	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Sweden,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of participants with adverse events		up to 104 weeks of treatment and a 90-day follow-up evaluation	Yes
Secondary	Lung function as measured by Forced Expiratory Volume in 1 second (FEV1)		104 weeks	No
Secondary	Lung function as measured by percent predicted Forced Expiratory Volume in 1 second (%FEV1)		104 weeks	No
Secondary	Lung function as measured by Forced Vital Capacity (FVC)		104 weeks	No
Secondary	Lung function as measured by Forced Expiratory Flow at 25% to 75% FVC (FEF25-75%)		104 weeks	No
Secondary	Short-acting Beta-agonist usage		104 weeks	No
Secondary	Asthma symptoms as measured by the Asthma Symptom Utility Index (ASUI)		104 weeks	No
Secondary	Asthma control as measured by the Asthma Control Questionnaire (ACQ)		104 weeks	No
Secondary	Quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ)		116 weeks	No