A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02546700
• Collaborator: (none)
• Enrollment: 309
• Locations: 66
• Arms: 4
• Actual Duration (Months): 13.9
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Lebrikizumab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 309 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Chronic Obstructive Pulmonary Disease and a History of Exacerbations
• Actual Study Start Date: Sep 30, 2015
• Actual Primary Completion Date: Nov 25, 2016
• Actual Study Completion Date: Nov 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lebrikizumab: Biomarker-high Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.	Drug: Lebrikizumab; Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Experimental: Lebrikizumab: Biomarker-low Lebrikizumab will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.	Drug: Lebrikizumab; Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
Placebo Comparator: Placebo: Biomarker-high Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-high.	Drug: Placebo; Matching placebo will be administered subcutaneously once in every 4 weeks.
Placebo Comparator: Placebo: Biomarker-low Matching placebo will be administered subcutaneously once in every 4 weeks up to 24 weeks to the participants considered as biomarker-low.	Drug: Placebo; Matching placebo will be administered subcutaneously once in every 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Absolute Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (FEV1) at Week 12 [Baseline, Week 12]

Secondary Outcome Measures

1. Rate of Moderate or Severe COPD Exacerbation [Baseline up to Week 24]

2. Absolute Change From Baseline in Post-bronchodilator FEV1 at Week 24 [Baseline, Week 24]

3. Absolute Change From Baseline in Pre-bronchodilator FEV1 at Week 24 [Baseline, Week 24]

4. Time to First COPD Exacerbation [Baseline up to Week 24]

5. 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]

6. 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]

7. 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]

8. Change From Baseline in Dyspnea as Assessed by the Baseline Dyspnea Index/Transition Dyspnea Index (BDI/TDI) at Week 24 [Baseline, Week 24]

9. Percentage of Participants with Adverse Events And Serious Adverse Events [Baseline up to Week 36]

10. Percentage of Participants with Anti-therapeutic Antibody (ATA) to Lebrikizumab [Baseline up to Week 36]

11. Minimum Observed Serum Trough Lebrikizumab Concentration (Cmin) [Pre-dose (Hour 0) at Weeks 4 and 12, at Week 24]

12. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented history of COPD greater than or equal to (>/=) 12 months prior to Visit 1

• Post-bronchodilator FEV1/FVC less than (<) 0.70 at Visit 1 or 2

• Post bronchodilator FEV1 <80% predicted at Visit 1 or 2

• Documented history of one or more acute COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics or hospitalization within 12 months prior to Visit 1

• Current tobacco smoker or former smoker (having stopped smoking for at least 6 months prior to Visit 1) with a history of smoking >/=10 pack-years (20 cigarettes/day for 10 years)

• On inhaled corticosteroids (ICS) therapy for >/=6 months prior to Visit 1

• On an eligible bronchodilator medication for >/=6 months prior to Visit 1

• Chest X-ray or computed tomography (CT) scan within 6 months prior to Visit 1 or chest X-ray prior to Visit 2 that confirms absence of clinically significant lung disease besides COPD

• Demonstrated adherence with background COPD inhaler medication during screening period

• For female participants of childbearing age, use of single or combined contraceptive methods for the duration of the study

Exclusion Criteria:

• History of severe allergic reaction or anaphylactic reaction to biologic agent or known hypersensitivity to lebrikizumab injection

• History of clinically significant pulmonary disease other than COPD

• Diagnosis of alpha-1-antitrypsin deficiency

• Lung volume reduction surgery or procedure within 12 months prior to Visit 1

• Supplemental oxygen requirement >2 liters/minute (L/min) at rest or with exertion

• Current diagnosis of asthma

• Participants participating in, or scheduled for, an intensive COPD rehabilitation program

• Maintenance oral corticosteroid therapy

• Treatment with systemic corticosteroids within 4 weeks prior to Visit 1 or during screen period

• Unstable ischemic heart disease or other relevant cardiovascular disorders

• Use of an immunomodulatory or immunosuppressive therapy including monoclonal antibodies (includes anti-interleukin-13 (IL) or anti-IL-4/IL-13 therapy)

• Body weight <40 kg

• Any infection that resulted in hospital admission for >/= 24 hours and/or treatment with oral, 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 or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening

• Received a live attenuated vaccine within 4 weeks prior to Visit 1 or during screening

• Active tuberculosis requiring treatment within 12 months prior to Visit 1

• Human immunodeficiency virus (HIV) or other known immunodeficiency

• Hepatitis or known liver cirrhosis

• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ATL), or total bilirubin elevation >/=2.0 x upper limit of normal (ULN) during screening

• Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests

• History of alcohol or drug abuse

• Pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
2	Phoenix Medical Research Institute, LLC; Phoenix Medical Research Institute, LLC	Peoria	Arizona	United States	85381
3	California Medical Research Associates, Inc.	Northridge	California	United States	91324
4	Palmtree Clinical research Inc	Palm Springs	California	United States	92262
5	Finlay Medical Research	Miami	Florida	United States	33126
6	Progressive Medical Research	Port Orange	Florida	United States	32127
7	Columbus Regional Research Institute	Columbus	Georgia	United States	31904
8	Southeast Regional Res Group	Savannah	Georgia	United States	31405
9	Centex Studies	Lake Charles	Louisiana	United States	70601
10	The Clinical Research Ctr	Saint Louis	Missouri	United States	63141
11	Comprehensive Clinical Research Inc.	Berlin	New Jersey	United States	08009
12	ISA Clinical Research	Jamaica	New York	United States	11435
13	Gastonia Pharmaceutical Research	Gastonia	North Carolina	United States	28054
14	Clinical Research Inst. of Southern Oregon, Pc	Medford	Oregon	United States	97504
15	Piedmont Research Partners LLC	Indian Land	South Carolina	United States	29707
16	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina	United States	29303
17	Baylor College of Medicine; Ben Taub Hospital- Guntupalli	Houston	Texas	United States	77030
18	Centex Studies	Houston	Texas	United States	77062
19	Western Washington Medical Group	Everett	Washington	United States	98208
20	Premier Clinical Research	Spokane	Washington	United States	99202
21	MultiCare Health Center of Washington	Tacoma	Washington	United States	98405
22	Centro Médico Dra de Salvo	Buenos Aires		Argentina	C1426ABP
23	Instituto Ave Pulmo	Mar Del Plata		Argentina	CP 7600
24	Centro Respiratorio Quilmes	Quilmes		Argentina	1878
25	Investigaciones en Patologias Respiratorias	San Miguel de Tucuman		Argentina	4000
26	Instituto Del Buen Aire	Santa Fe		Argentina	3000
27	Specialized Hospital For Active Treatment of Pneumophthisiatric Diseases; Dept of Pneumonology	Ruse		Bulgaria	7002
28	MHC - Sofia, EOOD	Sofia		Bulgaria	1202
29	Fifth MHAT - Sofia EAD	Sofia		Bulgaria	1233
30	National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases	Sofia		Bulgaria	2233
31	Medical Center "Nov Rehabilitatsionen Tsentar", EOOD	Stara Zagora		Bulgaria	6000
32	Medical Center Tara OOD	Veliko Tarnovo		Bulgaria	5000
33	Concordia Hospital,Repiratory Research	Winnipeg	Manitoba	Canada	R2K 3S8
34	McMaster University Medical Centre	Hamilton	Ontario	Canada	L8N 3Z5
35	St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N 4A6
36	Inspiration Research Limited	Toronto	Ontario	Canada	M5T 3A9
37	Hvidovre Hospital, Lungemedicinsk Afdeling	Hvidovre		Denmark	2650
38	Lungemedicinsk afd. L, Bispebjerg Hospital	København NV		Denmark	2400
39	Odense Universitetshospital, Lungemedicinsk Forskningsenhed	Odense C		Denmark	5000
40	Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )	Balassagyarmat		Hungary	2660
41	Petz Aladar Megyei Oktato Korhaz	Gyor		Hungary	9024
42	Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés	Komárom		Hungary	2900
43	CRU Hungary Kft	Miskolc		Hungary	3529
44	Mohacsi Korhaz	Mohacs		Hungary	7700
45	Matrai Állami Gyógyintézet ; Bronchológia	Mátraháza		Hungary	3233
46	Markusovszky Egyetemi Oktatokorhaz; Tudogondozo	Szombathely		Hungary	9700
47	Farmakontroll Bt.	Százhalombatta		Hungary	2440
48	Centro de Investigacion y Atencion Integral Durango CIAID	Durango		Mexico	34080
49	Instituto Jalisciense de Investigacion Clinica S.A. de C.V.	Guadalajara		Mexico	44100
50	Centro Respiratorio de México	Mexico		Mexico	14050
51	Oaxaca Site Management Organization	Oaxaca		Mexico	68000
52	Centro Integral Médico SJR SC	Querétaro		Mexico	76800
53	Mazowieckie Centrum Badan Klinicznych S.C.	Grodzisk Mazowiecki		Poland	05-825
54	MS Clinsearch Specjalistyczny NZOZ Janusz Milanowski Katarzyna Szmygin-Milanowska Spółka Jawna	Lublin		Poland	02-090
55	Poradnia Pulmonologiczna dla Doroslych	Lódz		Poland	90-153
56	Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala	Ruda Śląska		Poland	41-707
57	NZOZ Lekarze Specjalisci	Wroclaw		Poland	54-239
58	FSI Scientific Research Inst	Moscow		Russian Federation	105077
59	Central Clinical Hospital #1 of RZhD JCS	Moscow		Russian Federation	125367
60	Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2	Novosibirsk		Russian Federation	630008
61	State Novosibirsk Regional Clinical Hospital	Novosibirsk		Russian Federation	630087
62	LLC Reafan	Novosibirsk		Russian Federation	630099
63	LLC Medical Center "Alliance-Biomedical - Russian Group"	Saint Petersburg		Russian Federation	190068
64	SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF	St Petersburg		Russian Federation	197089
65	St. Petersburg State Medical University n.a. I.P. Pavlov	St. Petersburg		Russian Federation	197089
66	Siberian State Medical University	Tomsk		Russian Federation	634050

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02546700
• Other Study ID Numbers: WB29804; 2015-001122-42
• First Posted: Sep 11, 2015
• Last Update Posted: Sep 6, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Sep 6, 2017