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Search / Trial NCT05595642

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Launched by HOFFMANN-LA ROCHE · Oct 24, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called astegolimab to see how well it works and how safe it is for people with Chronic Obstructive Pulmonary Disease (COPD). This study is specifically for individuals who are former or current smokers and have experienced frequent worsening of their COPD symptoms. Participants will be compared to a group receiving a placebo, which is a treatment that looks like the real medicine but doesn't contain active ingredients. The goal is to find out if astegolimab can help reduce these flare-ups and improve overall lung function.

To be eligible for this trial, participants must have a diagnosed history of COPD for at least a year, have had at least two moderate or severe flare-ups in the past year, and meet specific lung function criteria. They should also be current smokers or have a history of smoking a certain amount. Participants will need to be stable on their current COPD treatment for at least a month before joining the study. If someone decides to participate, they can expect regular check-ups and assessments over the course of the trial to monitor their health and response to the treatment. This study is currently recruiting participants, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Documented COPD diagnosis for ≥ 12 months
  • History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
  • Post-bronchodilator FEV1 ≥ 20% and \< 80% of predicted at screening
  • Post-bronchodilator FEV1/FVC \< 0.70 at screening
  • Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
  • Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
  • On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
  • Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
  • Exclusion Criteria
  • Current documented diagnosis of asthma
  • History of clinically significant pulmonary disease other than COPD
  • Diagnosis of 1-antitrypsin deficiency
  • History of long-term treatment with oxygen at \> 4.0 liters/minute
  • Lung volume reduction surgery or procedure within 12 months prior to screening
  • Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
  • History of lung transplant
  • Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
  • Upper or lower respiratory tract infection within 4 weeks prior to or during screening
  • Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
  • Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months 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

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Adelaide, South Australia, Australia

Pessac, , France

Valencia, , Spain

Hong Kong, , Hong Kong

Vancouver, British Columbia, Canada

Birmingham, Alabama, United States

Newcastle Upon Tyne, , United Kingdom

Valencia, , Spain

Palo Alto, California, United States

Weston, Florida, United States

Burlington, Vermont, United States

Rosenheim, , Germany

Madrid, , Spain

Norwich, , United Kingdom

Vancouver, British Columbia, Canada

Birmingham, Alabama, United States

Dunedin, , New Zealand

Barcelona, , Spain

Leicester, , United Kingdom

Badalona, Barcelona, Spain

Alzira, Valencia, Spain

Portland, Oregon, United States

Tokyo, , Japan

Taipei, , Taiwan

Lancaster, , United Kingdom

Edinburgh, , United Kingdom

Bruxelles, , Belgium

Brussels, , Belgium

Sevilla, , Spain

Haifa, , Israel

Beijing, , China

Houston, Texas, United States

Khon Kaen, , Thailand

Auckland, , New Zealand

Leeds, , United Kingdom

Hiroshima, , Japan

Kiryu, , Japan

Kyoto, , Japan

Quezon City, , Philippines

Seoul, , Korea, Republic Of

Houston, Texas, United States

London, , United Kingdom

Daugavpils, , Latvia

Immenhausen, , Germany

Chattanooga, Tennessee, United States

Chengdu, , China

Bangkok, , Thailand

Louisville, Kentucky, United States

Taipei, , Taiwan

Coventry, , United Kingdom

Mersin, , Turkey

Kanagawa, , Japan

Kyoto, , Japan

Palma De Mallorca, Islas Baleares, Spain

Lucknow, Uttar Pradesh, India

Hong Kong, , Hong Kong

Manila, , Philippines

Hradec Kralove, , Czechia

Taoyuan, , Taiwan

Boerne, Texas, United States

Shenyang, Liaoning, China

Liège, , Belgium

Taipei, , Taiwan

Orlando, Florida, United States

Dunedin, , New Zealand

Berlin, , Germany

Heidelberg, , Germany

Daugavpils, , Latvia

Taipei City, , Taiwan

Goteborg, , Sweden

Milano, Lombardia, Italy

Madrid, , Spain

Hangzhou, Zhejiang, China

Hamburg, , Germany

Cottingham, Yorkshire, United Kingdom

Lexington, Kentucky, United States

Fukuoka, , Japan

Beek, , Netherlands

Beijing, , China

Kitakyushu Shi, , Japan

Quezon City, , Philippines

Houston, Texas, United States

Orlando, Florida, United States

Cottingham, , United Kingdom

Bloemfontein, , South Africa

Rosario, , Argentina

Pergamino, , Argentina

Lipa City, , Philippines

Nanjing, , China

Amersfoort, , Netherlands

Tokyo, , Japan

Seoul, , Korea, Republic Of

New Orleans, Louisiana, United States

Torino, Piemonte, Italy

Pavia, Lombardia, Italy

Hamilton, , New Zealand

Næstved, , Denmark

Saint Louis, Missouri, United States

Cheongju Si, , Korea, Republic Of

Haifa, , Israel

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Dallas, Texas, United States

Daegu, , Korea, Republic Of

Linhai, , China

Xiamen, , China

Buenos Aires, , Argentina

Niigata Shi, , Japan

Sapporo Shi, , Japan

Tauranga, , New Zealand

Craiova, , Romania

Kirikkale, , Turkey

Miami, Florida, United States

San Miguel De Tucuman, , Argentina

Smolyan, , Bulgaria

Veliko Tarnovo, , Bulgaria

Paris, , France

Machida Shi, , Japan

Tokyo, , Japan

Auckland, , New Zealand

Nedlands, Western Australia, Australia

Santa Fe, , Argentina

Santo Andre, Sp, Brazil

München, , Germany

Jerusalem, , Israel

Greensboro, North Carolina, United States

Gastonia, North Carolina, United States

Groningen, , Netherlands

Iloilo City, , Philippines

Xuzhou, , China

Pittsburgh, Pennsylvania, United States

Taipei City, , Taiwan

New Delhi Delhi, Delhi, India

Kocaeli, , Turkey

Groningen, , Netherlands

Guangzhou, Guangdong, China

Sofia, , Bulgaria

Florence, Toscana, Italy

Nanchang, Jiangxi, China

Salt Lake City, Utah, United States

Gdynia, , Poland

Montreal, Quebec, Canada

Wuxi, , China

Herakleion, , Greece

Palermo, Sicilia, Italy

Wonju Si, , Korea, Republic Of

Katowice, , Poland

Pavia, Lombardia, Italy

Wuxi, , China

Catania, Sicilia, Italy

Sakai Shi, , Japan

New Taipei, , Taiwan

Tatabánya, , Hungary

Porto Alegre, Rio Grande Do Sul, Brazil

Beijing, , China

Changchun City, , China

Jerusalem, Yerushalayim, Israel

Farkasgyepu, , Hungary

Zutphen, , Netherlands

Beer Sheva, , Israel

Torrejon De Ardoz, Madrid, Spain

Toledo, Ohio, United States

Vitoria, Es, Brazil

Gabrovo, , Bulgaria

Rosario, , Argentina

Everett, Washington, United States

Columbia, South Carolina, United States

Guangdong, , China

Shanghai, , China

Orbassano, Piemonte, Italy

Chang Hua, , Taiwan

Tianjin, , China

Kfar Saba, , Israel

Ishikawa, , Japan

Wonju Si, , Korea, Republic Of

Darmstadt, , Germany

Hannover, , Germany

Saint Charles Borromee, Quebec, Canada

Nanjing, , China

Kagoshima, , Japan

Bucheon Si,, , Korea, Republic Of

Centurion, , South Africa

Athens, , Greece

Magdeburg, , Germany

Nagpur, Maharashtra, India

Tabor, , Czechia

Gyongyos, , Hungary

Gyeonggi Do, , Korea, Republic Of

Shanghai, , China

Altoona, Pennsylvania, United States

Chikushino Shi, , Japan

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Timisoara, , Romania

Guangzhou, , China

Nanjing City, , China

Las Vegas, Nevada, United States

Balassagyarmat, , Hungary

Roskilde, , Denmark

Beijing City, , China

Ioannina, , Greece

Sofia, , Bulgaria

Tulsa, Oklahoma, United States

Beijing City, , China

Haifa, , Israel

Haikou, , China

Windsor, Ontario, Canada

Altamonte Springs, Florida, United States

Mibu Machi, , Japan

Wroclaw, , Poland

Guangzhou, Guangdong, China

Hangzhou, Zhejiang, China

Pingxiang, , China

Houston, Texas, United States

Zhanjiang, Guangdong, China

Aichi, , Japan

Shizuoka, , Japan

Kaoshiung City, , Taiwan

Changsha, , China

Zunyi, Guizhou, China

Flint, Michigan, United States

Ahmedabad, Gujarat, India

Zigong, , China

Feldbach, , Austria

Kyjov, , Czechia

Joyo, , Japan

Valencia, , Spain

Nantong, , China

Xinxiang, , China

Zunyi, , China

Quillota, , Chile

Bakersfield, California, United States

Brugge, , Belgium

Okinawa, , Japan

Hefei, , China

Beijing, , China

Riga, , Latvia

Rio De Janeiro, , Brazil

Sofia, , Bulgaria

Saint Charles, Missouri, United States

Shumen, , Bulgaria

Rome, Lazio, Italy

Pessac, , France

Walnut Creek, California, United States

Bellevue, Nebraska, United States

Edmond, Oklahoma, United States

Sofia, , Bulgaria

Sofia, , Bulgaria

Mexico, Mexico City (Federal District), Mexico

Franklin, Tennessee, United States

Durham, North Carolina, United States

Sao Bernardo Do Campo, Sp, Brazil

Lübeck, , Germany

Plovdiv, , Bulgaria

Lianyungang, , China

Passo Fundo, Rs, Brazil

Brandon, Florida, United States

Miami, Florida, United States

Napoli, Campania, Italy

Kumamoto Shi, , Japan

Hanoi, , Vietnam

Blagoevgrad, , Bulgaria

Barcelona, , Spain

Corby, , United Kingdom

Houston, Texas, United States

Bydgoszcz, , Poland

Czestochowa, , Poland

Warszawa, , Poland

Birmingham, , United Kingdom

Cardiff, , United Kingdom

Chorley, , United Kingdom

Huntersville, North Carolina, United States

Daugavpils, , Latvia

Sao Bernardo Do Campo, , Brazil

Hubli, Karnataka, India

Windsor, Ontario, Canada

Amiens, , France

Kolkata, West Bengal, India

Csorna, , Hungary

Mobile, Alabama, United States

Lathrup Village, Michigan, United States

Winston Salem, North Carolina, United States

Sosnowiec, , Poland

Passo Fundo, Rio Grande Do Sul, Brazil

Athina, , Greece

Bologna, Emilia Romagna, Italy

The Villages, Florida, United States

New York, New York, United States

Montana, , Bulgaria

Franklin, Tennessee, United States

Ajax, Ontario, Canada

Nairobi, , Kenya

Porto Alegre, Rs, Brazil

Denver, North Carolina, United States

Torun, , Poland

Alexandroupolis, , Greece

Lublin, , Poland

Miami, Florida, United States

Ho Chi Minh City, , Vietnam

Muang, , Thailand

Changsha, , China

Atlanta, Georgia, United States

Guangzhou, , China

R?Ga, , Latvia

Bia?Ystok, , Poland

Greenacres City, Florida, United States

Kanpur, Uttar Pradesh, India

Flint, Michigan, United States

Gaffney, South Carolina, United States

Dothan, Alabama, United States

Bangor, Maine, United States

Berlin, New Jersey, United States

Wroc?Aw, , Poland

Orlando, Florida, United States

Ormond Beach, Florida, United States

Hammond, Indiana, United States

Reno, Nevada, United States

Austin, Texas, United States

Corsicana, Texas, United States

Riga, , Latvia

Porto Alegre, Rio Grande Do Sul, Brazil

Chongqing City, , China

Anniston, Alabama, United States

Birmingham, Alabama, United States

Glendale, Arizona, United States

Glendale, Arizona, United States

Tucson, Arizona, United States

Vista, California, United States

Coconut Creek, Florida, United States

Stonecrest, Georgia, United States

Cincinnati, Ohio, United States

Houston, Texas, United States

Katy, Texas, United States

Tampa, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Columbus, Georgia, United States

Huber Heights, Ohio, United States

Hendersonville, Tennessee, United States

Houston, Texas, United States

Trzebnica, , Poland

City Of Johannesburg, , South Africa

Kempton Park, , South Africa

Krugersdorp, , South Africa

Pretoria, , South Africa

Dimitrovgrad, , Bulgaria

Varna, , Bulgaria

Hamburg, , Germany

Debrecen, , Hungary

Riga, , Latvia

Paraparaumu, , New Zealand

Bydgoszcz, , Poland

Bydgoszcz, , Poland

Katowice, , Poland

Krakow, , Poland

Wroc?Aw, , Poland

Zabrze, , Poland

Cluj Napoca, , Romania

Benalmadena Costa, Malaga, Spain

Okayama, , Japan

Johannesburg, , South Africa

Greenfield, Wisconsin, United States

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Mendoza, , Argentina

San Nicolas De Los Arroyos, , Argentina

Opava, , Czechia

Teplice, , Czechia

Berlin, , Germany

Neu Isenburg, , Germany

Rheine, , Germany

Palaio Faliro, , Greece

Thessaloniki, , Greece

Heerlen, , Netherlands

Chojnice, , Poland

Grudzadz, , Poland

Ksawerów, , Poland

Lodz, , Poland

Lublin, , Poland

Radom, , Poland

Sopot, , Poland

Szczecin, , Poland

Tarnow, , Poland

Wroc?Aw, , Poland

Zurich, , Switzerland

Heraklio, , Greece

Cz?Stochowa, , Poland

Gda?Sk, , Poland

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Concepcion Del Uruguay, , Argentina

Parana, , Argentina

Ranelagh, Berazategui, , Argentina

Rosario, , Argentina

San Salvador, , Argentina

Santa Fe, , Argentina

Linz, , Austria

Pavie Gallegos, , Chile

Vina Del Mar, , Chile

Vitacura, , Chile

Leipzig, , Germany

Athens, , Greece

Pretoria, , South Africa

Somerset West, , South Africa

Linköping, , Sweden

Solna, , Sweden

Stockholm, , Sweden

Dubois, Pennsylvania, United States

Schenectady, New York, United States

Las Vegas, Nevada, United States

Fayetteville, North Carolina, United States

Mauldin, South Carolina, United States

Houston, Texas, United States

Midlothian, Virginia, United States

Cordoba, , Argentina

Entre Rios, , Argentina

La Plata, , Argentina

Sofia, , Bulgaria

Varna, , Bulgaria

Edmonton, Alberta, Canada

Teplice, , Czechia

Berlin, , Germany

Timisoara, , Romania

Ponferrada, Leon, Spain

Linkoping, , Sweden

Uppsala, , Sweden

Troy, Michigan, United States

Berlin, , Germany

Bellshill, , United Kingdom

Manchester, , United Kingdom

Ciudad Autonoma De Buenos Aires, , Argentina

Silistra, , Bulgaria

Brandys Nad Labem Stara Boleslav, , Czechia

Vandoeuvre, , France

Frankfurt, , Germany

Frankfurt, , Germany

Leipzig, , Germany

Machakos, , Kenya

Grudziadz, , Poland

Lodz, , Poland

Chesterfield, , United Kingdom

Hexham, , United Kingdom

Belo Horizonte, Mg, Brazil

Miami, Florida, United States

Birmingham, Alabama, United States

Longwood, Florida, United States

Miami, Florida, United States

Farmington Hills, Michigan, United States

Houston, Texas, United States

La Plata, , Argentina

La Plata, , Argentina

Brasilia, Df, Brazil

Rio De Janeiro, Rj, Brazil

Sao Paulo, Sp, Brazil

Razgrad, , Bulgaria

Sherwood Park, Alberta, Canada

Quebec, , Canada

Huizhou, , China

Praha 1, , Czechia

Praha, , Czechia

Srikakulam, Andhra Pradesh, India

Faridabad, Haryana, India

Hubli, Karnataka, India

Nagpur, Maharashtra, India

Ajmer, Rajasthan, India

Jaipur, Rajasthan, India

Hyderabad, Telangana, India

Lucknow, Uttar Pradesh, India

Hastings, , New Zealand

Slupsk, , Poland

Guaynabo, , Puerto Rico

Orebro, , Sweden

Edgbaston, , United Kingdom

Liverpool, , United Kingdom

Santa Fe, , Argentina

Toyama Shi, , Japan

Little Rock, Arkansas, United States

Beijing, , China

Wuxi, , China

Zigong, , China

Daugavpils, , Latvia

Iloilo City, , Philippines

Quezon City, , Philippines

Montreal, Quebec, Canada

Istanbul, , Turkey

Hyderabad, Andhra Pradesh, India

Cheongju Si, , Korea, Republic Of

Chengdu, , China

Yangzhou, , China

Ahmadabad City, Gujarat, India

Pune, Maharashtra, India

Ferrara, Emilia Romagna, Italy

Chuo, , Japan

Himeji, , Japan

Shizuoka, , Japan

Takamatsu, , Japan

Yanagawa, , Japan

Dasmarinas, , Philippines

Tarnow, , Poland

Welkom, , South Africa

High Wycombe, , United Kingdom

London, , United Kingdom

Guaynabo, , Puerto Rico

Jaipur, Rajasthan, India

Xian, , China

Porto Alegre, Rs, Brazil

Botucatu, Sp, Brazil

Chongqing, , China

Wuhan, , China

New Delhi, Delhi, India

Pune City, Maharashtra, India

Siena, Toscana, Italy

Himeji, , Japan

Kilifi, , Kenya

Nairobi, , Kenya

Siaya, , Kenya

Thika, , Kenya

Caloocan City, , Philippines

Rize Merkez, , Turkey

Saricam, , Turkey

Lancaster, California, United States

Gainesville, Florida, United States

Lathrup Village, Michigan, United States

Madison Heights, Michigan, United States

Saint Louis, Missouri, United States

North Plainfield, New Jersey, United States

Bronx, New York, United States

Pittsburgh, Pennsylvania, United States

Desoto, Texas, United States

Zhuhai City, , China

Brno, , Czechia

Lille, , France

Budapest, , Hungary

Ahmadabad City, Gujarat, India

Nagpur, Maharashtra, India

Battipaglia, Campania, Italy

Reggio Emilia, Emilia Romagna, Italy

Fukuoka Shi Nishi Ku, , Japan

Kawachinagano Shi, , Japan

Kishiwada, , Japan

Koto, , Japan

Mie, , Japan

Oita, , Japan

Okayama Shi Minami Ku, , Japan

Omuta, , Japan

Sagamihara Shi Minami Ku, , Japan

Sapporo Shi Chuo Ku, , Japan

Takasaki, , Japan

Tanabe, , Japan

Yokohama Shi Aoba Ku, , Japan

Oaxaca De Juárez, Mexico City (Federal District), Mexico

Queretaro, , Mexico

Sosnowiec, , Poland

City Of Cape Town, , South Africa

Roodepoort, , South Africa

Ho Chi Minh City, , Vietnam

Las Vegas, Nevada, United States

Beijing City, , China

Asahikawa Shi, , Japan

Chikushino Shi, , Japan

Miyagi, , Japan

Nagoya Shi Minami Ku, , Japan

Yokohama Shi Totsuka Ku, , Japan

Yonezawa, , Japan

New Orleans, Louisiana, United States

Edeleny, , Hungary

Gödöll?, , Hungary

Hajdunanas, , Hungary

Komlo, , Hungary

Sakaide, , Japan

Yokohama Shi Kanazawa Ku, , Japan

Lodz, Lódzkie, Poland

Edmonton, Alberta, Canada

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Sakai Shi, , Japan

Washington, Connecticut, United States

East Brunswick, New Jersey, United States

Buffalo, New York, United States

New Hyde Park, New York, United States

Berazategui, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Concepcion Del Uruguay, , Argentina

La Plata, , Argentina

Mendoza, , Argentina

Parana, , Argentina

Rosario, , Argentina

San Miguel De Tucuman, , Argentina

Santiago, , Chile

Leipzig, , Germany

Santo Andre, São Paulo, Brazil

Vitoria, Espírito Santo, Brazil

Ginowan Shi, Okinawa, Japan

Belo Horizonte, Minas Gerais, Brazil

Phoenix, Arizona, United States

Houston, Texas, United States

Buenos Aires, , Argentina

Ciudad Autónoma De Buenos Aires, , Argentina

Mendoza, , Argentina

Parana, , Argentina

Rosario, , Argentina

Midland, South Australia, Australia

Brasilia, Distrito Federal, Brazil

Botucatu, São Paulo, Brazil

Sao Bernardo Do Campo, São Paulo, Brazil

Sao Paulo, São Paulo, Brazil

Hefei City, , China

Hyderabad, Andhra Pradesh, India

New Delhi, Delhi, India

Hubballi, Karnataka, India

Aligarh, Uttar Pradesh, India

Yonezawa, , Japan

Riga, , Latvia

Waikanae Beach, , New Zealand

Kaoshiung City, , Taiwan

Edmond, Oklahoma, United States

Bellevue, Nebraska, United States

Lübeck, Schleswig Holstein, Germany

Berlin, , Germany

Chuo Ku, Fukuoka Shi, , Japan

Naka Gun, , Japan

Kilifi, Coast, Kenya

Pretoria, , South Africa

Marlton, New Jersey, United States

Shanghai, , China

São Paulo, , Brazil

Mangaung, Free State, South Africa

City Of Johannesburg, Gauteng, South Africa

Lianyungang, Jiangsu, China

Budapest, Pest, Hungary

Hubballi, Karnataka, India

Shizuoka, , Japan

Santo Andre, , Brazil

Vitoria, , Brazil

Botucatu, , Brazil

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Hoffmann-La Roche

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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