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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001122-42 | EudraCT Number |
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Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one long-acting bronchodilator inhaler medication. This study will be conducted to assess the safety, efficacy, and patient-reported outcome (PRO) measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab: Biomarker-high | Experimental | Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. |
|
| Lebrikizumab: Biomarker-low | Experimental | Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low. |
|
| Placebo: Biomarker-high | Placebo Comparator | Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high. |
|
| Placebo: Biomarker-low | Placebo Comparator | Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12 | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Moderate or Severe COPD Exacerbation | Baseline up to Week 24 | |
| Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24 | Baseline, Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | United States | ||
| Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC |
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| Placebo | Drug | Matching placebo will be administered subcutaneously once in every 4 weeks. |
|
| Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24 |
| Baseline, Week 24 |
| Time to First COPD Exacerbation | Baseline up to Week 24 |
| Change From Baseline in Health-related Quality of Life as Assessed by the Overall Score of the Saint George's Respiratory Questionnaire for COPD (SGRQ-C) at Week 24 | Baseline, Week 24 |
| Change From Baseline in COPD Symptoms as Measured by the Overall Score of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) at Week 24 | Baseline, Week 24 |
| Change From Baseline in Cough and Sputum as Measured by the Cough and Sputum Domain Score of the EXACT at Week 24 | Baseline, Week 24 |
| Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24 | Baseline, Week 24 |
| Percentage of Participants with Adverse Events And Serious Adverse Events | Baseline up to Week 36 |
| Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab | Baseline up to Week 36 |
| Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) | Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24 |
| Plasma Decay Half-Life (t1/2) | Pre-dose (Hour 0) on Day 1 (Baseline) and Weeks 1, 4, 8, 12, 16, 20; at Weeks 24, 28, and 36 |
| Peoria |
| Arizona |
| 85381 |
| United States |
| California Medical Research Associates, Inc. | Northridge | California | 91324 | United States |
| Palmtree Clinical research Inc | Palm Springs | California | 92262 | United States |
| Finlay Medical Research | Miami | Florida | 33126 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Southeast Regional Res Group | Savannah | Georgia | 31405 | United States |
| Centex Studies | Lake Charles | Louisiana | 70601 | United States |
| The Clinical Research Ctr | St Louis | Missouri | 63141 | United States |
| Comprehensive Clinical Research Inc. | Berlin | New Jersey | 08009 | United States |
| ISA Clinical Research | Jamaica | New York | 11435 | United States |
| Gastonia Pharmaceutical Research | Gastonia | North Carolina | 28054 | United States |
| Clinical Research Inst. of Southern Oregon, Pc | Medford | Oregon | 97504 | United States |
| Piedmont Research Partners LLC | Old Point Station | South Carolina | 29707 | United States |
| S. Carolina Pharmaceutical Research | Spartanburg | South Carolina | 29303 | United States |
| Baylor College of Medicine; Ben Taub Hospital- Guntupalli | Houston | Texas | 77030 | United States |
| Centex Studies | Houston | Texas | 77062 | United States |
| Western Washington Medical Group | Everett | Washington | 98208 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| MultiCare Health Center of Washington | Tacoma | Washington | 98405 | United States |
| Centro Médico Dra de Salvo | Buenos Aires | C1426ABP | Argentina |
| Instituto Ave Pulmo | Mar del Plata | CP 7600 | Argentina |
| Centro Respiratorio Quilmes | Quilmes | 1878 | Argentina |
| Investigaciones en Patologias Respiratorias | San Miguel de Tucumán | 4000 | Argentina |
| Instituto Del Buen Aire | Santa Fe | 3000 | Argentina |
| Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology | Rousse | 7002 | Bulgaria |
| MHC - Sofia, EOOD | Sofia | 1202 | Bulgaria |
| Fifth MHAT - Sofia EAD | Sofia | 1233 | Bulgaria |
| National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases | Sofia | 2233 | Bulgaria |
| Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora | 6000 | Bulgaria |
| Medical Center Tara OOD | Veliko Tarnovo | 5000 | Bulgaria |
| Concordia Hospital,Repiratory Research | Winnipeg | Manitoba | R2K 3S8 | Canada |
| McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Inspiration Research Limited | Toronto | Ontario | M5T 3A9 | Canada |
| Hvidovre Hospital, Lungemedicinsk Afdeling | Hvidovre | 2650 | Denmark |
| Lungemedicinsk afd. L, Bispebjerg Hospital | København NV | 2400 | Denmark |
| Odense Universitetshospital, Lungemedicinsk Forskningsenhed | Odense C | 5000 | Denmark |
| Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept ) | Balassagyarmat | 2660 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés | Komárom | 2900 | Hungary |
| Matrai Állami Gyógyintézet ; Bronchológia | Mátraháza | 3233 | Hungary |
| CRU Hungary Kft | Miskolc | 3529 | Hungary |
| Mohacsi Korhaz | Mohács | 7700 | Hungary |
| Farmakontroll Bt. | Százhalombatta | 2440 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz; Tudogondozo | Szombathely | 9700 | Hungary |
| Centro de Investigacion y Atencion Integral Durango CIAID | Durango | 34080 | Mexico |
| Instituto Jalisciense de Investigacion Clinica S.A. de C.V. | Guadalajara | 44100 | Mexico |
| Centro Respiratorio de México | México | 14050 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Centro Integral Médico SJR SC | Querétaro | 76800 | Mexico |
| Mazowieckie Centrum Badan Klinicznych S.C. | Grodzisk Mazowiecki | 05-825 | Poland |
| Poradnia Pulmonologiczna dla Doroslych | Lódz | 90-153 | Poland |
| MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna | Lublin | 02-090 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala | Ruda Śląska | 41-707 | Poland |
| NZOZ Lekarze Specjalisci | Wroclaw | 54-239 | Poland |
| FSI Scientific Research Inst | Moscow | 105077 | Russia |
| Central Clinical Hospital #1 of RZhD JCS | Moscow | 125367 | Russia |
| Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2 | Novosibirsk | 630008 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| LLC Reafan | Novosibirsk | 630099 | Russia |
| LLC Medical Center "Alliance-Biomedical - Russian Group" | Saint Petersburg | 190068 | Russia |
| SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Saint Petersburg | 197089 | Russia |
| St. Petersburg State Medical University n.a. I.P. Pavlov | Saint Petersburg | 197089 | Russia |
| Siberian State Medical University | Tomsk | 634050 | Russia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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