A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
2017년 5월 19일 업데이트: Hoffmann-La Roche
A Phase II, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients With Severe Corticosteroid Dependent Asthma
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma.
Prednisone/prednisolone will be the OCS therapy prescribed.
Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period.
Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment.
Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period.
Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
연구 개요
연구 유형
중재적
등록 (실제)
230
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 1105 AZ
- Academisch Medisch Centrum; Afdeling Longziekten, F5-258
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Hoofddorp, 네덜란드, 2134 TM
- Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde
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Nieuwegein, 네덜란드, 3435 CM
- Antonius Ziekenhuis; Dept of Lung Diseases
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Auckland, 뉴질랜드, 1051
- NZ Respiratory & Sleep Institute
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Dunedin, 뉴질랜드
- Dunedin Hospital
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Tauranga, 뉴질랜드, 3143
- Clinical Trials Unit, Bay of Plenty District Health Board
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Wellington, 뉴질랜드
- Medical Research Inst. of New Zealand; Respiratory
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Hellerup, 덴마크, 2900
- Gentofte Hospital, Klinik for Allergi
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Guadalajara, 멕시코, 44100
- Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
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Guadalajara, 멕시코, 44130
- Centro Investigacion Medico Biologica y Terapia Avanzada
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Querétaro, 멕시코, 76800
- Centro Integral Médico SJR SC
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California
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Bakersfield, California, 미국, 93301
- Kern Allergy Med Clinic, Inc.
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Long Beach, California, 미국, 90808
- Allergy & Asthma Care Center of Southern California
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Florida
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Miami, Florida, 미국, 33135
- South Florida Research Center, Inc.
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Georgia
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Albany, Georgia, 미국, 31707
- Georgia Pollens
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New York
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New York, New York, 미국, 10029
- Mount Sinai Medical Center
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- Allergy & Immunology
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Texas
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Houston, Texas, 미국, 77008
- Pioneer Research Solutions
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McKinney, Texas, 미국, 75069
- Metroplex Pulmonology & Sleep Center
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Washington
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Tacoma, Washington, 미국, 98405
- Pulmonary Consultants PLLC
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Bruxelles, 벨기에, 1070
- Clin Univ de Bxl Hôpital Erasme
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Genk, 벨기에, 3600
- Longartsenpraktijk
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Gent, 벨기에, 9000
- UZ Gent
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Barcelona, 스페인, 08036
- Hospital Clinic de Barcelona
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Barcelona, 스페인, 08025
- Hospital de la Santa Creu; i Sant Pau
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Salamanca, 스페인, 37007
- Hospital Clinico Universitario de Salamanca; Servicio de Neumologia
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Valencia, 스페인, 46017
- Hospital Universitario Doctor Peset
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La Coruña
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Santiago de Compostela, La Coruña, 스페인, 15706
- Complejo Hospitalario Universitario de Santiago; Servicio de Neumología
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Levice, 슬로바키아, 934 01
- ZAPA JJ Sro
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Spisska Nova Ves, 슬로바키아, 052 01
- Plucna ambulancia
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Golnik, 슬로베니아, 4204
- University Clinic of Pulmonary and Allergic Diseases Golnik
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Belfast, 영국, BT9 7AB
- Belfast City Hospital; Respiratory Department
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Birmingham, 영국, B9 5SS
- Heartlands Hospital; Respiratory Department
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Glasgow, 영국, G51 4TF
- Royal Hospital for Children
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Glasgow, 영국, G12 0YN
- Gartnavel General Hospital; Respiratory Department
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Glasgow, 영국, G31 2ER
- New Lister Buliding, Level 1; Clinical Research Facility
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Hampshire, 영국, SO16 6YD
- Southampton General Hospital; Respiratory Department
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Leicester, 영국, LE1 5WW
- Leicester Royal Infirmary NHS Trust
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Leicester, 영국, LE3 9QP
- Glenfield Hospital; Respiratory -Allergy Unit
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London, 영국, SW3 6NP
- Royal Brompton Hospital; Respiratory Department
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London, 영국, EC1A 7BE
- St Bartholomew's Hospital (Barts); Respiratory Department
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Manchester, 영국, M23 9LT
- Wythenshawe Hospital; North West Lung Research Centre
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Newcastle upon Tyne, 영국, NE7 7DN
- Freeman Hospital; Respiratory Department
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Plymouth, 영국, PL6 8DH
- Derriford Hospital; The Lind Research Department
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Sheffield, 영국, S10 2JF
- Sheffield Clinical Research Facility; National Institute for Health Research
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Brno, 체코, 618 00
- Hornmed
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Liberec 1, 체코, 460 63
- Nemocnice Liberec; KNL a.s. - TRN
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Nový Jičín, 체코, 741-01
- Nemocnice Novy Jicin
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Rokycany, 체코, 337 22
- Rokycanska nemocnice
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Ontario
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Toronto, Ontario, 캐나다, M5T 3A9
- Inspiration Research Limited
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Krakow, 폴란드, 31-624
- Malopolskie Centrum Alergologii
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Krakow, 폴란드, 31-024
- Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-MED
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Lodz, 폴란드, 90-153
- SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
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Ostrow Wielkopolski, 폴란드, 63-400
- Specjalistyczna Poradnia Pulmonologiczna
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Ruda Śląska, 폴란드, 41-707
- Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala
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Warszawa, 폴란드, 02-507
- Klinika Chorób Wewnetrznych i Alergologii MSW
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Wrocław, 폴란드, 50-220
- EMC Instytut Medyczny SA; Przychodnia przy ulicy Łowieckiej
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Caguas, 푸에르토 리코, 00725
- San Juan Bautista School of Medicine-Clinical Research Unit
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Cidra, 푸에르토 리코, 00739
- Advanced Medical Concepts, PSC
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Grenoble Cedex 9, 프랑스, 38043
- CHU de Grenoble - Hôpital André Michallon
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Le Kremlin Bicetre, 프랑스, 94275
- CH de Bicetre; Pneumologie
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Lyon, 프랑스, 69004
- Hôpital de la Croix Rousse
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Montpellier, 프랑스, 34295
- Hopital Arnaud de Villeneuve
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Nantes, 프랑스, 44093
- CHU Nantes - Hôpital Laennec; Service de Pneumologie
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Nice Cedex 1, 프랑스, 06001
- CHU de Nice
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Paris, 프랑스, 75877
- Hopital Bichat Claude Bernard ; Service de Pneumologie
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Pessac, 프랑스, 33604
- CHU de Haut Leveque
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Strabourg, 프랑스, 67091
- Nouvel Hopital Civil; Pole de Pathologie Thoracique
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Queensland
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Brisbane, Queensland, 호주, 4102
- Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine
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Victoria
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Clayton, Victoria, 호주, 3168
- Monash Medical Centre; Respiratory and Sleep Medicine
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Western Australia
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Nedlands, Western Australia, 호주, 6009
- Institute for Respiratory Health Inc
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Severe asthma despite intensive follow-up by an asthma specialist for >/=6 months prior to Visit 1
- Baseline forced expiratory volume in 1 second (FEV1) >/=40% of predicted prior to randomization
- Receiving high doses of inhaled glucocorticosteroids at a total daily dose of >/=1500 micrograms (mcg) beclomethasone dipropionate or equivalent and long-acting beta-adrenoceptor agonist (LABA), with or without an additional controller, for at least 3 months prior to Visit 1
- Chronic treatment with maintenance OCS for >/=6 months prior to Visit 1
- Assessment to ensure diagnosis of refractory asthma and OCS dependence on minimal effective or maximum tolerated dose prior to Visit 1 with compliance
Exclusion Criteria:
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Asthma exacerbation within 28 days prior to Visit 1 or during screening (prior to Visit 3)
- For adults: Active tuberculosis requiring treatment within the 12 months prior to Visit 1
- For adolescents: History of active tuberculosis requiring treatment
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Known current malignancy or current evaluation for a potential malignancy
- History of interstitial lung disease, chronic obstructive pulmonary disease, or other clinically significant lung disease other than asthma
- Infection requiring hospital admission or requiring treatment with intravenous (IV) or intramuscular (IM) antibiotics within 4 weeks prior to Visit 1 or during screening
- Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening
- Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
- Current smoker or former smoker with a smoking history of more than 15 pack-years
- Current use of an immunomodulatory/ immunosuppressive therapy or past use within 3 months or 5 drug half-lives (whichever is longer) prior to Visit 1
- Use of a licensed or investigational monoclonal antibody other than anti-interleukin (IL)-13 or anti-IL-4/IL-13, including but not limited to, omalizumab, anti-IL-5, or anti-IL-17, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
- Receipt of a live attenuated vaccine within the 4 weeks prior to Visit 1 during screening or anticipation of receipt of a live attenuated vaccine throughout the study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Lebrikizumab High Dose
Participants will receive lebrikizumab at high dose level as subcutaneous (SC) injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
다른 이름들:
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실험적: Lebrikizumab Low Dose
Participants will receive lebrikizumab at low dose level as SC injection every 4 weeks during the 44-week DBPC period, followed by a 32-week ATE period, and during the LTE period.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
다른 이름들:
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위약 비교기: Placebo
Participants will receive placebo matching to lebrikizumab SC injection every 4 weeks during the 44-week DBPC period.
Participants will then be randomized to receive either high- or low-dose lebrikizumab every 4 weeks during the 32-week ATE period and will continue same treatment in the LTE period.
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Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
다른 이름들:
Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Relative Change From Baseline in Daily OCS Dose at Week 44
기간: Baseline, Week 44
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Baseline, Week 44
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Absolute Change From Baseline in Daily OCS Dose at Week 44
기간: Baseline, Week 44
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Baseline, Week 44
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Relative Change From Week 12 in Average OCS Dose at Week 44
기간: Week 12, Week 44
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Week 12, Week 44
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Percentage of Participants Achieving at Least a 50 percent (%) Reduction in Their Daily OCS Dose at Week 44 Relative to Baseline
기간: Baseline, Week 44
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Baseline, Week 44
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Percentage of Participants Discontinuing OCS Therapy or Having Achieved an Adrenal Maintenance Dose at Week 44
기간: Week 44
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Percentage of participants discontinuing OCS therapy or having achieved adrenal maintenance dose (cortisol level less than or equal to 100 nanomoles per liter) will be reported.
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Week 44
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Percentage of Participants With Asthma Exacerbations
기간: Baseline up to Week 44
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An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, or nocturnal awakenings due to these symptoms) that lead to treatment with systemic corticosteroids greater than or equal to (>/=) 30 milligrams (mg) or 0.5 mg per kilogram (kg) for >/=3 consecutive days or to hospitalization.
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Baseline up to Week 44
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Percentage of Participants With Adverse Events
기간: Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Baseline up to 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Percentage of Participants With Anti-therapeutic Antibodies (ATAs) Against Lebrikizumab
기간: Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Predose (0 hours) at Weeks 0, 4, 12, 24, 36, 44, 52, 64, and 76, at early discontinuation (up to a minimum of approximately 2 years), and at 24 weeks after last dose administration (up to a minimum of approximately 2 years)
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Minimum Observed Serum Lebrikizumab Concentration (Cmin)
기간: Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
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Predose (0 hours) at Weeks 4, 12, 24, 36, and 44
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 2월 28일
기본 완료 (실제)
2016년 12월 20일
연구 완료 (실제)
2016년 12월 20일
연구 등록 날짜
최초 제출
2013년 11월 12일
QC 기준을 충족하는 최초 제출
2013년 11월 12일
처음 게시됨 (추정)
2013년 11월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 19일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .