A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Sponsor

Genentech, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05037929

Collaborator

(none)

930

Enrollment

171

Locations

Arms

33.9

Anticipated Duration (Months)

5.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

930 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Astegolimab Q2W Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).	Drug: Astegolimab Participants will receive SC astegolimab Q2W or Q4W.
Experimental: Astegolimab Q4W Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).	Drug: Astegolimab Participants will receive SC astegolimab Q2W or Q4W.
Placebo Comparator: Placebo Participants will receive SC placebo Q2W.	Drug: Placebo Participants will receive SC placebo Q2W.

Arm

Intervention/Treatment

Experimental: Astegolimab Q2W

Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).

Drug: Astegolimab

Participants will receive SC astegolimab Q2W or Q4W.

Experimental: Astegolimab Q4W

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).

Drug: Astegolimab

Participants will receive SC astegolimab Q2W or Q4W.

Placebo Comparator: Placebo

Participants will receive SC placebo Q2W.

Drug: Placebo

Participants will receive SC placebo Q2W.

Outcome Measures

Primary Outcome Measures

Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period [Baseline up to Week 52]

Secondary Outcome Measures

Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period [Baseline up to Week 52]
Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score [Baseline to Week 52]
Proportion of SGRQ-C Responders at Week 52 [Baseline to Week 52]
Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 [Baseline to Week 52]
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 [Baseline to Week 52]
Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period [Baseline up to Week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Documented physician diagnosis of COPD for at least 12 months
History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
Current or former smoker with a minimum of 10 pack-year history
History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Exclusion Criteria

Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
History of clinically significant pulmonary disease other than COPD
History of long-term treatment with oxygen at >4.0 liters/minute
Lung volume reduction surgery or procedure within 12 months prior to screening
Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
History of lung transplant
Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SEC Clinical Research LLC - Andalusia - ClinEdge - PPDS	Andalusia	Alabama	United States	36420-5310
2	Jasper Summit Research LLC	Jasper	Alabama	United States	35501
3	Pulmonary Associates of Mobile PC	Mobile	Alabama	United States	36608-3135
4	Phoenix Medical Group PC	Peoria	Arizona	United States	85381-4872
5	IMD Clinical Trials	Bakersfield	California	United States	93309-0609
6	CARE Clinical Research	Banning	California	United States	92220
7	Cadena Care Institute, LLC	Poway	California	United States	92064-2021
8	Inst. of Healthcare Assessment, Inc.	San Diego	California	United States	92120
9	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California	United States	90502
10	Allianz Research Institute Inc	Westminster	California	United States	92683
11	St. Francis Sleep; Allergy & Lung Institute	Clearwater	Florida	United States	33765
12	Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDS	Leesburg	Florida	United States	34748-5077
13	Pulmonary Specialists of the Palm Beaches	Loxahatchee Groves	Florida	United States	33470-9206
14	Suncoast Research Group LLC	Miami	Florida	United States	33135
15	Florida Institute for Clinical Research, LLC	Orlando	Florida	United States	32822
16	Cardio-Pulmonary Associates	Plantation	Florida	United States	33317
17	Clinical Site Partners - Winter Park - HyperCore - PPDS	Winter Park	Florida	United States	32789-4681
18	Columbus Regional Research Institute at Talbotton - IACT - HyperCore - PPDS	Columbus	Georgia	United States	31904-8946
19	Medisphere Medical Research Center, Llc	Evansville	Indiana	United States	47714
20	Exordia Medical Research, Inc.	Fall River	Massachusetts	United States	20723
21	Northern Pines Health Center PC	Buckley	Michigan	United States	49620
22	Revive Research Institute	Lathrup Village	Michigan	United States	48076
23	Oakland Medical Research	Troy	Michigan	United States	48085
24	Midwest Chest Consultants	Saint Charles	Missouri	United States	63301
25	Midwest Clinical Research LLC	Saint Louis	Missouri	United States	63141
26	Sierra Clinical Research - ClinEdge - PPDS	Las Vegas	Nevada	United States	89106-4159
27	American Health Research Inc.	Charlotte	North Carolina	United States	28277
28	Clinical Research of Gastonia	Gastonia	North Carolina	United States	28054
29	Carolina Research Center	Shelby	North Carolina	United States	28150-3803
30	Southeastern Research Center	Winston-Salem	North Carolina	United States	27103-4029
31	Keystone VitaLink Research	Anderson	South Carolina	United States	29621 2062
32	Carolina Medical Research, LLC	Clinton	South Carolina	United States	29325-7556
33	Piedmont Research Partners LLC - Clinedge - PPDS	Fort Mill	South Carolina	United States	29707-4526
34	Lowcountry Lung and Critical Care	North Charleston	South Carolina	United States	29406
35	Clinical Research of Rock Hill	Rock Hill	South Carolina	United States	29732
36	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
37	South Texas Medical Research Institute, Inc., dba TTS Research - ClinEdge - PPDS	Boerne	Texas	United States	78006-1993
38	Horizon Clinical Research Group: Houston Pulmonary Sleep & Allergy Associates -Clinedge - PPDS	Houston	Texas	United States	77070
39	Metroplex Pulmonology & Sleep Center	McKinney	Texas	United States	75069
40	Sherman Clinical Research - ClinEdge - PPDS	Sherman	Texas	United States	75092
41	Instituto de Investigaciones Clinicas-Mar del Plata	Buenos Aires		Argentina	B7600FZN
42	Fundacion Cidea	Buenos Aires		Argentina	C1121ABE
43	Centro Médico Dra de Salvo	Buenos Aires		Argentina	C1426ABP
44	CARE - Centro de Alergia y Enfermedades Respiratorias	Caba		Argentina	C1414AIF
45	Centro de Investigaciones Clínicas Belgrano	Ciudad Autónoma De Buenos Aires		Argentina	7240
46	Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility	Córdoba		Argentina	X5003DCE
47	Centro de Especialidades Medicas Lobos	Lobos		Argentina	B7240AAN
48	Centro de Investigaciones Medicas Mar Del Plata	Mar del Plata		Argentina	B7600DHK
49	Instituto Ave Pulmo	Mar Del Plata		Argentina	B7602DCK
50	Fundacion Scherbovsky	Mendoza		Argentina	M5500AYB
51	Centro Respiratorio Quilmes	Quilmes		Argentina	B1878FNR
52	Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica	Rosario		Argentina	S2013OJN
53	Centro Medico IPAM	Rosario		Argentina	S2013SBK
54	Investigaciones en Patologias Respiratorias	San Miguel de Tucuman		Argentina	T4000IAR
55	Centro Integral de Medicina Respiratoria (CIMER)	San Miguel de Tucumán		Argentina	T4000CHE
56	Instituto De Enfermedades Respiratorias E Investigacion Medica	Villa Vatteone		Argentina	B1853AIK
57	Westmead Hospital	Westmead	New South Wales	Australia	2145
58	Box Hill Hospital	Box Hill	Victoria	Australia	3128
59	TrialsWest Pty Ltd	Spearwood	Western Australia	Australia	6163
60	Medizinische Universitat Wien Medical University of Vienna	Wien		Austria	1090
61	UZ Antwerpen	Edegem		Belgium	2650
62	Private Practice Dr Jean Benoit Martinot	Erpent		Belgium	5101
63	AZ Sint-Maarten	Mechelen		Belgium	2800
64	AZ Delta	Roeselare		Belgium	8800
65	Office of Marc De Meulemeester	Thuin		Belgium	6534
66	CHU UCl Namur asbl - Site Godinne	Yoir		Belgium	5530
67	Medical Centre "Asklepii", OOD	Dupnitsa		Bulgaria	2600
68	Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD	Haskovo		Bulgaria	6305
69	Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD	Pernik		Bulgaria	2300
70	Medical center Medconsult Pleven OOD	Pleven		Bulgaria	5800
71	University Multiprofile Hospital for Active Treatment Sveti Georgi EAD	Plovdiv		Bulgaria	4002
72	Medical center Unimed EOOD	Plovdiv		Bulgaria	4023
73	Medical Centre Respiro OOD	Razgrad		Bulgaria	7200
74	Medical Center Hera EOOD	Sofia		Bulgaria	1510
75	Medical Center New rehabilitation center EOOD	Stara Zagora		Bulgaria	6003
76	Burlington Lung Clinic	Burlington	Ontario	Canada	L7N 3V2
77	Clinique de pneumologie et du sommeil de Lanaudiere	Saint-Charles-Borromee	Quebec	Canada	J6E 2B4
78	Centro de Investigación Curico	Curico		Chile	3340000
79	Sociedad Médica SyG SpA	Providencia		Chile	7500000
80	Enroll SpA - PPDS	Providencia		Chile	7500587
81	Centro de Investigaciones Medicas Respiratorias	Santiago		Chile	7500692
82	Meditek Ltda	Santiago		Chile	8320000
83	Centro de Investigacion del Maule	Talca		Chile
84	Hospital Carlos Van Buren	Valparaiso		Chile	2340000
85	MIRES/MYF estudios cli-nicos	Ñuñoa		Chile	7750495
86	MediTrial s.r.o.	Jindřichův Hradec		Czechia	377 01
87	Plicni Ambulance Kralupy nad Vltavou	Kralupy nad Vltavou		Czechia	278 01
88	MUDr. Ilona Pavlisova s.r.o.	Miroslav		Czechia	671 72
89	Pneumologie Varnsdorf S.r.o.	Novy Bor		Czechia	473 01
90	Plicni stredisko	Strakonice		Czechia	386 01
91	KASMED s.r.o.	Tabor		Czechia	390 01
92	Hôpital de La Croix Rousse	Lyon		France	69004
93	Hopital Saint Joseph - Marseille	Marseille		France	13008
94	CHU de Nice	Nice Cedex 1		France	06001
95	Nouvel Hôpital Civil	Strasbourg		France	67091
96	Zentrum fuer Pneumologie, Onkologie und Schlafmedizin am Diako	Augsburg		Germany	86150
97	CIMS-Studienzentrum Bamberg,	Bamberg		Germany
98	MECS Research GmbH	Berlin		Germany	12203
99	Praxis Dr. Med Evelin Liefring	Berlin		Germany	13187
100	Gemeinscharftspraxis Dres Jung - Deggingen	Deggingen		Germany	73326
101	Medizentrum Essen Borbeck	Essen		Germany	45355
102	Praxis Dr med Claus Keller	Frankfurt am Main		Germany	60389
103	KPPK Studienzentrum Kroker-Schmidt	Koblenz		Germany	56068
104	Praxis Dr. Steffen	Landsberg		Germany	86899
105	Salvus-Klinische Studien GmbH	Leipzig		Germany	04207
106	Zentrum fuer ambulante pneumologische Forschung Marburg GbR	Marburg		Germany	35037
107	Studienzentrum Dr Med Schlenska	Peine		Germany	31224
108	Barzilai Medical Center	Ashkelon		Israel	7830604
109	Shaare Zedek Medical Center	Jerusalem		Israel	9103102
110	Rabin Medical Center	Petach Tiqwa		Israel	4941492
111	Sheba Medical Center - PPDS	Ramat-Gan		Israel	5262000
112	Kaplan Medical Center	Rehovot		Israel	7610001
113	Catholic Univ. of Incheon St.Mary's Hospital	Incheon		Korea, Republic of	21431
114	Chonbuk National University Hospital	Jeollabuk-do		Korea, Republic of	54907
115	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
116	Konkuk University Medical Center	Seoul		Korea, Republic of	05030
117	CICUM San Miguel	Americana	Jalisco	Mexico	44160
118	Centro de Investigacion y Atencion Integral Durango CIAID	Durango		Mexico	34080
119	Instituto Jalisciense de Investigacion Clinica S.A. de C.V.	Guadalajara		Mexico	44100
120	Unidad Medica de Occidente	Guadalajara		Mexico	44220
121	Amphia Ziekenhuis	Breda		Netherlands	4819 EV
122	Catharina Hospital; Apotheek	Eindhoven		Netherlands	5623 EJ
123	Dijklander Ziekenhuis - loc Hoorn	Hoorn		Netherlands	1624 NP
124	Isala Klinieken	Zwolle		Netherlands	8011 JW
125	NZ Respiratory & Sleep Institute	Auckland		New Zealand	1051
126	Canterbury Respiratory Research Group	Christchurch		New Zealand	8011
127	P3 Research - Tauranga	Tauranga		New Zealand	3110
128	P3 Research	Tauranga		New Zealand	3110
129	Centrum Medyczne Bydgoszcz- PRATIA - PPDS	Bydgoszcz		Poland	85-796
130	Indywidualna Specjalistyczna Praktyka Lekarska lek.	Kielce		Poland	25-751
131	Centrum Medyczne ALL-MED	Krakow		Poland	30-033
132	Diamond Clinic	Kraków		Poland	31-209
133	Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.	Kraków		Poland	31-637
134	ETG Lublin	Lublin		Poland	20-412
135	ETG Lodz	Lódz		Poland	90-302
136	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sól		Poland	67-100
137	Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olec-Cudzik; Krzysztof Cudzik	Ostrowiec Swietokrzysk		Poland	27-400
138	Centrum Alergologii Teresa Hofman	Poznan		Poland	60-214
139	EMED Centrum Uslug Medycznych Ewa Smialek	Rzeszów		Poland	35-205
140	ETG Siedlce	Siedlce		Poland	08-110
141	PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna	Sosnowiec		Poland	41-200
142	ETG Warszawa	Warszawa		Poland	02-777
143	Dobrostan Gabinety Lekarskie	Wroclaw		Poland	53-301
144	Neomed Out-Patient Treatment and Diagnosis Medical Center SRL	Brasov		Romania	500283
145	Dr. Victor Babes Foundation	Bucuresti		Romania	030303
146	Leon Daniello Pneumophthisiology Clinical Hospital	Cluj-Napoca		Romania	400371
147	Spitalul Clinic de Pneumoftiziologie Constanta	Constanta		Romania	900002
148	Sf. Ioan cel Nou Emergency County Hospital	Suceava		Romania	720224
149	University of Cape Town Lung Institute; Lung Clinical Research	Cape Town		South Africa	7700
150	Clinical Trial Systems	City Of Tshwane		South Africa	0186
151	St Augustines Hospital	Durban		South Africa	4001
152	Dr A.C Wilhase practice-Reimed	Ekurhuleni		South Africa	1459
153	Lakeview Hospital	Ekurhuleni		South Africa	1501
154	Langeberg Clinical Trials	Kraaifontein		South Africa	7570
155	Hospital de Merida	Merida	Badajoz	Spain	06800
156	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
157	CHUS - H. Clinico U. de Santiago	Santiago de Compostela	LA Coruña	Spain	15706
158	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid	Spain	28223
159	Hospital de San Pedro de Alcantara	Caceres		Spain	10003
160	Hospital Universitario Virgen de Las Nieves	Granada		Spain	18012
161	Hospital Arnau de Vilanova	Lerida		Spain	25198
162	Hospital General Universitario Gregorio Maranon	Madrid		Spain	28040
163	Hospital Universitario Fundacion Jimenez Diaz.	Madrid		Spain	28040
164	Hospital Universitario Virgen de la Victoria	Malaga		Spain	29010
165	Öbackakliniken	Härnösand		Sweden	871 31
166	ProbarE i Lund AB	Lund		Sweden	222 22
167	PharmaSite	Malmö		Sweden	211 52
168	ProbarE i Stockholm AB	Stockholm		Sweden	SE-17145
169	Bradford Royal Infirmary	Bradford		United Kingdom	BD9 6RJ
170	Glenfield Hospital	Leicester		United Kingdom	LE3 9QP
171	Queen Anne Street Medical Centre	London		United Kingdom	W1G 8HU