AERIFY-1: Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

• Sponsor: Sanofi (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04701983
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 930
• Locations: 159
• Arms: 3
• Anticipated Duration (Months): 40.5
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Primary Objective:

Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

• Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD

• Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD

• Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD

• Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD

• Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Itepekimab SAR440340; Drug: Placebo	Phase 3

Detailed Description

The study duration per participant is approximatively 76 weeks including a 3-to-5-week screening period, a 52-week treatment period on investigational medicinal product (IMP) and a 20-week post-IMP treatment follow-up period.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 930 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
• Actual Study Start Date: Dec 16, 2020
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Itepekimab Q2W Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for 52 weeks	Drug: Itepekimab SAR440340; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous; Other Names: REGN3500
Experimental: Itepekimab Q4W SC administration of Itepekimab every 4 weeks (Q4W) for 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP	Drug: Itepekimab SAR440340; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous; Other Names: REGN3500 ; Drug: Placebo; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Placebo Comparator: Placebo SC administration of matching placebo Q2W for 52 weeks	Drug: Placebo; Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Outcome Measures

Primary Outcome Measures

1. Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) [Baseline up to Week 52]

   Annualized rate of moderate or severe AECOPD over the 52-week placebo-controlled treatment period

Secondary Outcome Measures

1. Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 52 [Baseline to Week 52]

   FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

2. Change from baseline in post-BD FEV1 at Week 52 [Baseline to Week 52]

   FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

3. Change from baseline in pre-BD FEV1 at Week 24 [Baseline to Week 24]

   FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

4. Time to first moderate or severe AECOPD [Baseline through Week 52]

   Time to first moderate or severe AECOPD over the 52 week placebo-controlled treatment period.

5. Annualized rate of severe AECOPD [Baseline up to Week 52]

   Annualized rate of severe AECOPD over the 52 week placebo-controlled treatment period.

6. Time to first severe AECOPD [Baseline through Week 52]

   Time to first severe AECOPD over the 52-week placebo-controlled treatment period.

7. Annualized rate of corticosteroid-treated AECOPD [Baseline up to Week 52]

   Annualized rate of corticosteroid-treated AECOPD over the 52-week placebo-controlled treatment period.

8. Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52 [Baseline to Week 52]

   The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.

9. Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) [Baseline up to Week 52]

   FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

10. Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score at Week 52 [Baseline to Week 52]

    The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.

11. Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 52 [Baseline to Week 52]

    The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.

12. Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation [Baseline up to end of study (Week 72)]

13. Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities [Baseline up to end of study (Week 72)]

14. Functional itepekimab concentrations in serum [Baseline up to end of study (Week 72)]

15. Incidence of treatment-emergent anti-itepekimab antibodies responses [Baseline up to end of study (Week 72)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria :

• Participant must be 40 to 85 years of age inclusive.

• Physician diagnosis of COPD for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition.

• Smoking history of ≥10 pack-years, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.

• Participants with moderate-to-severe COPD

• Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year prior to screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded).

• Documented history of high exacerbation risk defined as having had ≥2 moderate or ≥1 severe exacerbations within the year prior to Screening (Visit 1A), with at least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy:

• Moderate exacerbations will be recorded by the Investigator and are defined as acute worsening of respiratory symptoms that requires either systemic corticosteroids (IM, IV, or oral) and/or antibiotics.

• Severe exacerbations will be recorded by the Investigator and are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.

• Participants with standard of care controller therapy, for ≥3 months prior to Screening (Visit 1A) and at a stable dose of controller therapy for at least 1 month prior to the screening, including either: inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.

• Body mass index (BMI) ≥18.0 kg/m^2

• Female participant is not pregnant, not breastfeeding, and at least one of the following conditions applies:

• not a women of child-bearing potential (WOCBP) OR

• a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.

Exclusion criteria:

• Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.

• Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A).

• Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening (Visit 1A) that may affect the participant's participation in the study.

• Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease.

• Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension.

• Hypercapnia requiring bilevel positive airway pressure (BiPAP).

• Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to Screening (Visit 1A).

• Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded.

• Unstable ischemic heart disease, including acute myocardial infarction within the past 1 year prior to Screening, or unstable angina in the 6 months prior to Screening (Visit 1A).

• Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial fibrillation.

• Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP

110 mm Hg with or without use of anti-hypertensive therapy).

• Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI), or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).

• History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1A).

• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to sScreening (Visit 1A); participants who have had a COVID-19 infection prior Screening (Visit 1A) who have not yet sufficiently recovered to participate in the procedures of a clinical trial.

• Evidence of acute or chronic infection requiring systemic treatment with anti bacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment).

• Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis.

• History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.

• Previous use of itepekimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham-Site Number:8400012	Birmingham	Alabama	United States	34294
2	Jasper Summit Research-Site Number:8400178	Jasper	Alabama	United States	00000
3	MedPharmics, LLC-Site Number:8400185	Mobile	Alabama	United States	36608
4	Noble Clinical Research-Site Number:8400182	Tucson	Arizona	United States	85704-7876
5	Antelope Valley Clinical Trials-Site Number:8400003	Northridge	California	United States	91325
6	Alpine Clinical Research Center-Site Number:8400180	Boulder	Colorado	United States	80301
7	Innovative Clinical Research-Site Number:8400017	Lafayette	Colorado	United States	80026
8	Clin Research W Florida-Site Number:8400004	Clearwater	Florida	United States	33765
9	Indago Research and Health Center-Site Number:8400187	Hialeah	Florida	United States	33012
10	Deluxe Health Center-Site Number:8400188	Miami Lakes	Florida	United States	33014
11	Research Institute of South Florida,Inc-Site Number:8400006	Miami	Florida	United States	33173
12	Florida Institute for Clinical Research-Site Number:8400013	Orlando	Florida	United States	32825-4454
13	Sonar Group-Site Number:8400183	East Point	Georgia	United States	30344
14	Alpha Clinical Research Georgia-Site Number:8400190	Johns Creek	Georgia	United States	30022
15	Gwinnett Biomedical Research-Site Number:8400007	Lawrenceville	Georgia	United States	30046
16	Benchmark Research-Site Number:8400193	Covington	Louisiana	United States	70433
17	Paul Shapero, PC-Site Number:8400016	Bangor	Maine	United States	04401
18	Revival Research Institute, LLC-Site Number:8400191	Dearborn	Michigan	United States	48126
19	Midwest Chest Consultants, P.C.-Site Number:8400002	Saint Charles	Missouri	United States	63301
20	Gastonia Pharmaceutical Research-Site Number:8400010	Gastonia	North Carolina	United States	28054
21	Carolina Research Center-Site Number:8400005	Shelby	North Carolina	United States	28150
22	Accellacare-Site Number:8400001	Wilmington	North Carolina	United States	28401
23	Southeastern Research Center-Site Number:8400011	Winston-Salem	North Carolina	United States	27103
24	Bernstien Clinical Research Center-Site Number:8400014	Cincinnati	Ohio	United States	45231
25	Bogan Sleep Consultants-Site Number:8400181	Columbia	South Carolina	United States	29201
26	Clinical Research of Rock Hill-Site Number:8400008	Rock Hill	South Carolina	United States	29732
27	Corsicana Medical Research, LLC-Site Number:8400018	Corsicana	Texas	United States	75110
28	Metroplex Pulmonary and Sleep Center-Site Number:8400015	McKinney	Texas	United States	75069
29	Sherman Clinical Research-Site Number:8400009	Sherman	Texas	United States	75092
30	DM Clinical Research-Site Number:8400179	Tomball	Texas	United States	77375
31	Investigational Site Number :0320001	Caba	Buenos Aires	Argentina	C1425BEN
32	Investigational Site Number :0320002	Caba	Buenos Aires	Argentina	C1425FVH
33	Investigational Site Number :0320003	Rosario	Santa Fe	Argentina	S2000DEJ
34	Investigational Site Number :0320004	Mendoza		Argentina	5500
35	Investigational Site Number :1000005	Dimitrovgrad		Bulgaria	6400
36	Investigational Site Number :1000001	Sofia		Bulgaria	1233
37	Investigational Site Number :1000004	Sofia		Bulgaria	1233
38	Investigational Site Number :1000002	Sofia		Bulgaria	1407
39	Investigational Site Number :1000003	Stara Zagora		Bulgaria	6001
40	Investigational Site Number :1520007	Curicó	Maule	Chile	3341643
41	Investigational Site Number :1520002	Talca	Maule	Chile
42	Investigational Site Number :1520009	Santiago	Reg Metropolitana De Santiago	Chile	7500010
43	Investigational Site Number :1520003	Santiago	Reg Metropolitana De Santiago	Chile	7500571
44	Investigational Site Number :1520001	Santiago	Reg Metropolitana De Santiago	Chile	7500692
45	Investigational Site Number :1520006	Santiago	Reg Metropolitana De Santiago	Chile	7500698
46	Investigational Site Number :1520004	Santiago	Reg Metropolitana De Santiago	Chile	8910131
47	Investigational Site Number :1520005	Quillota		Chile	2260877
48	Investigational Site Number :1520008	Temuco		Chile	4781173
49	Investigational Site Number :1560003	Baotou		China	014010
50	Investigational Site Number :1560004	Beijing		China	100020
51	Investigational Site Number :1560030	Beijing		China	100038
52	Investigational Site Number :1560014	Beijing		China
53	Investigational Site Number :1560002	Changchun		China	130021
54	Investigational Site Number :1560012	Changsha		China	410011
55	Investigational Site Number :1560013	Changsha		China	410013
56	Investigational Site Number :1560047	Changsha		China	410023
57	Investigational Site Number :1560001	Chengdu		China	610041
58	Investigational Site Number :1560040	Chengdu		China	611130
59	Investigational Site Number :1560032	Chongqing		China	400038
60	Investigational Site Number :1560025	Guangzhou		China	510120
61	Investigational Site Number :1560006	Guangzhou		China	510150
62	Investigational Site Number :1560036	Haikou		China	570216
63	Investigational Site Number :1560022	Hangzhou		China	310014
64	Investigational Site Number :1560039	Hangzhou		China
65	Investigational Site Number :1560017	Hefei		China
66	Investigational Site Number :1560008	Hohhot		China	010017
67	Investigational Site Number :1560010	Hohhot		China	010050
68	Investigational Site Number :1560044	Jinan		China	250013
69	Investigational Site Number :1560027	Jinan		China	250014
70	Investigational Site Number :1560031	Nanchang		China	330006
71	Investigational Site Number :1560038	Nanchang		China	330006
72	Investigational Site Number :1560035	Nanjing		China	210009
73	Investigational Site Number :1560023	Nanning		China	530021
74	Investigational Site Number :1560015	Pingxiang		China	337055
75	Investigational Site Number :1560043	Shanghai		China	200025
76	Investigational Site Number :1560034	Shanghai		China	200240
77	Investigational Site Number :1560009	Shanghai		China	200433
78	Investigational Site Number :1560005	Shenyang		China	110004
79	Investigational Site Number :1560020	Shenzhen		China	518020
80	Investigational Site Number :1560028	Shijiazhuang		China	050000
81	Investigational Site Number :1560024	Tianjin		China	300052
82	Investigational Site Number :1560019	Wenzhou		China	325000
83	Investigational Site Number :1560029	Wuhan		China	430014
84	Investigational Site Number :1560016	Xi'an		China
85	Investigational Site Number :1560046	Xiangtan		China	411100
86	Investigational Site Number :1560007	Xuzhou		China	221002
87	Investigational Site Number :1560026	Yangzhou		China	225001
88	Investigational Site Number :1560021	Yinchuan		China	750004
89	Investigational Site Number :1560041	Zhanjiang		China	524001
90	Investigational Site Number :1560042	Zhengzhou		China	450008
91	Investigational Site Number :1560018	Zunyi		China	563000
92	Investigational Site Number :2030001	Jindrichuv Hradec III		Czechia	37701
93	Investigational Site Number :2030004	Ostrava		Czechia	70800
94	Investigational Site Number :2030002	Praha 4		Czechia	140 46
95	Investigational Site Number :2030005	Praha 5 - Radotin		Czechia	15300
96	Investigational Site Number :2030003	Praha 8		Czechia	18200
97	Investigational Site Number :3000005	Athens		Greece	106 76
98	Investigational Site Number :3000004	Heraklion		Greece	71110
99	Investigational Site Number :3000001	Ioannina		Greece	455 00
100	Investigational Site Number :3000002	Thessaloniki		Greece	57010
101	Investigational Site Number :3480004	Debrecen		Hungary	4031
102	Investigational Site Number :3480001	Gödöllő		Hungary	2100
103	Investigational Site Number :3480002	Mosonmagyaróvár		Hungary	9200
104	Investigational Site Number :3480003	Pécs		Hungary	7635
105	Investigational Site Number :3760003	Jerusalem		Israel	91031
106	Investigational Site Number :3760002	Jerusalem		Israel	91120
107	Investigational Site Number :3760006	Kfar-Saba		Israel	44281
108	Investigational Site Number :3760001	Petah-Tikva		Israel	49100
109	Investigational Site Number :3760004	Rehovot		Israel	76100
110	Investigational Site Number :3760007	Tel Aviv		Israel	64239
111	Investigational Site Number :3800003	Rozzano	Milano	Italy	20089
112	Investigational Site Number :3800004	Foggia	Puglia	Italy	71122
113	Investigational Site Number :3800005	Catania		Italy	95123
114	Investigational Site Number :3800001	Ferrara		Italy	44124
115	Investigational Site Number :3800007	Verona		Italy	37134
116	Investigational Site Number :4840001	Guadalajara	Jalisco	Mexico	44100
117	Investigational Site Number :4840007	Cuernavaca	Morelos	Mexico	62250
118	Investigational Site Number :4840004	Benito Juarez		Mexico	03100
119	Investigational Site Number :4840002	Cdmx		Mexico	06700
120	Investigational Site Number :4840003	San Juan del Rio		Mexico	76800
121	Investigational Site Number :6160004	Wroclaw	Dolnoslaskie	Poland	50-088
122	Investigational Site Number :6160003	Warszawa	Mazowieckie	Poland	02-777
123	Investigational Site Number :6160001	Bialystok	Podlaskie	Poland	15-044
124	Investigational Site Number :6160002	Ostrowiec Swietokrzyski	Swietokrzyskie	Poland	27-400
125	Investigational Site Number :6420005	Bragadiru		Romania	769764
126	Investigational Site Number :6420006	Brasov		Romania	500283
127	Investigational Site Number :6420012	Bucaresti		Romania	010192
128	Investigational Site Number :6420002	Cluj-Napoca		Romania	400275
129	Investigational Site Number :6420007	Codlea		Romania	505100
130	Investigational Site Number :6420010	Deva		Romania	330162
131	Investigational Site Number :6420001	Iasi		Romania	700732
132	Investigational Site Number :6420009	Oradea		Romania	410169
133	Investigational Site Number :6420003	Timisoara		Romania	300134
134	Investigational Site Number :6430001	Moscow		Russian Federation	115093
135	Investigational Site Number :6430003	Moscow		Russian Federation	115280
136	Investigational Site Number :6430002	Moscow		Russian Federation	117546
137	Investigational Site Number :6430005	Saint-Petersburg		Russian Federation	194354
138	Investigational Site Number :6430006	St-Petersburg		Russian Federation	194354
139	Investigational Site Number :7030009	Bardejov		Slovakia	08501
140	Investigational Site Number :7030007	Humenne		Slovakia	066 01
141	Investigational Site Number :7030003	Levice		Slovakia	93401
142	Investigational Site Number :7030011	Martin		Slovakia	03659
143	Investigational Site Number :7030002	Poprad		Slovakia	058 01
144	Investigational Site Number :7030001	Spisska Nova Ves		Slovakia	05201
145	Investigational Site Number :1580005	Kaohsiung		Taiwan	807
146	Investigational Site Number :1580002	New Taipei City		Taiwan	220
147	Investigational Site Number :1580007	Taichung		Taiwan	402
148	Investigational Site Number :1580006	Taichung		Taiwan	40447
149	Investigational Site Number :1580004	Taipei		Taiwan	10002
150	Investigational Site Number :1580003	Taipei		Taiwan	11031
151	Investigational Site Number :1580008	Yunlin		Taiwan
152	Investigational Site Number :8040003	Ivano-Frankivsk		Ukraine	76018
153	Investigational Site Number :8040007	Ivano-Frankivsk		Ukraine	76018
154	Investigational Site Number :8040008	Kharkiv		Ukraine	61039
155	Investigational Site Number :8040006	Kharkiv		Ukraine	61166
156	Investigational Site Number :8040004	Kyiv		Ukraine	01023
157	Investigational Site Number :8040001	Kyiv		Ukraine	01033
158	Investigational Site Number :8040005	Kyiv		Ukraine	02091
159	Investigational Site Number :8040011	Kyiv		Ukraine	04050

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT04701983
• Other Study ID Numbers: EFC16750; 2020-001818-38; U1111-1250-2787
• First Posted: Jan 8, 2021
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 13, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 14, 2022