A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma | NCT06376045 | Trialant

A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma | NCT06376045 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Participants must be between the ages of 18 and 75.

Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.

Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist [LTRA], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.

Documented history of ≥ 1 asthma exacerbation in the past year prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 μg fluticasone propionate or equivalent ICS).

Morning pre-BD FEV1 ≥ 35% and ≤ 90% of predicted normal at the screening visit and day 1 pre-randomization visits.

ACQ-6 score ≥ 1.5 at the day 1 pre randomization visit.

Exclusion Criteria:

Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.

Any clinically important pulmonary disease other than asthma.

Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of > 10 pack-years.

Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.

Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.

Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.

Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent

History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.

Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.

Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.

Active and non-virally suppressed hepatitis B infection at initial screening,

Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

Kern Research Inc

Bakersfield, California 93301, United States

Orso Health Inc

La Jolla, California 92037, United States

Imax Clinical Trials

La Palma, California 90623, United States

Antelope Valley Clinical Trials

Lancaster, California 93534, United States

Downtown Los Angeles Research Center, Inc

Los Angeles, California 90017, United States

NewportNativeMD, Inc

Newport Beach, California 92663, United States

University of California Irvine

Orange, California 92868, United States

Apex Clinical Research

San Diego, California 92120, United States

Allergy and Asthma Clinical Research

Walnut Creek, California 94598, United States

Allianz Research Institute Westminster

Westminster, California 92683, United States

St Francis Medical Institute

Clearwater, Florida 33765, United States

BioMed Research Institute

Miami, Florida 33126, United States

Bright Research Center LLC

Miami, Florida 33144, United States

Infinity Life Research Group

Tamarac, Florida 33321, United States

Clinical Research Trials of Florida Inc

Tampa, Florida 33607, United States

AllerVie Clinical Research- Columbus

Columbus, Georgia 31904, United States

Treasure Valley Medical Research

Boise, Idaho 83706, United States

Sneeze, Wheeze, and Itch Associates, LLC

Normal, Illinois 61761, United States

Family Allergy and Asthma Research Institute

Louisville, Kentucky 40217, United States

Chesapeake Clinical Research Inc

White Marsh, Maryland 21162, United States

Henry Ford Health System

Detroit, Michigan 48202, United States

Respiratory Medicine Research Institute of Michigan, plc

Ypsilanti, Michigan 48197, United States

Midwest Chest Consultants, PC

Saint Charles, Missouri 63301, United States

Montana Medical Research

Missoula, Montana 59808, United States

Somnos Clinical Research

Lincoln, Nebraska 68505, United States

Hudson County Clinical Trials Research Center

Union City, New Jersey 07087, United States

Northwell Health

New Hyde Park, New York 11042, United States

Duke Asthma Research Center

Durham, North Carolina 27705, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157, United States

Bernstein Clinical Research Center LLC

Cincinnati, Ohio 45236, United States

OK Clinical Research

Edmond, Oklahoma 73034, United States

Velocity Clinical Research Medford

Medford, Oregon 97504, United States

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania 15801, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213, United States

The Allergy Asthma and Sinus Center

Knoxville, Tennessee 37909, United States

Amarillo Medical Specialists

Amarillo, Texas 79124, United States

TTS Research

Boerne, Texas 78006, United States

TEN20 Clinical Research

Carrollton, Texas 75010, United States

Alina Clinical Trials, LLC

Dallas, Texas 75225, United States

Southwest Family Medicine Associates

Dallas, Texas 75235, United States

University of Texas Medical Branch

Galveston, Texas 77555-0158, United States

Baylor College of Medicine

Houston, Texas 77030, United States

Sante Clinical Research

Kerrville, Texas 78028, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas 75069, United States

Ace Proactive

Plano, Texas 75093, United States

South Texas Allergy and Asthma Medical Professionals

San Antonio, Texas 78229, United States

Bandera Family Health Care

San Antonio, Texas 78249, United States

Pioneer Research Solutions Inc

Sugar Land, Texas 77479, United States

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CABA, Buenos Aires C1426ABP, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina

Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador

Mar del Plata, Buenos Aires 7600, Argentina

Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica

San Juan Bautista, Buenos Aires 1888, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal 1425, Argentina

Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica

Rosario, Santa Fe Province S2002OJN, Argentina

Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Cemer Centro Medico de Enfermedades Respiratorias

Florida, Vicente Lopez, B1602DQD, Argentina

Instituto Medico Insares SA

Mendoza, 5500, Argentina

Fundacion Scherbovsky

Mendoza, M5500AXR, Argentina

Westmead Hospital

Westmead, New South Wales 2145, Australia

The Alfred Hospital

Melbourne, Victoria 3141, Australia

Medical Center Pulmo - 2018 EOOD

Haskovo, 6300, Bulgaria

Specialized Hospital for Active Treatment of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov

Rousse, 7002, Bulgaria

Medical Center Excelsior OOD

Sofia, 1407, Bulgaria

Diagnostic-Consultative Center Convex OOD

Sofia, 1680, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6001, Bulgaria

University of Calgary - Cumming School of Medicine

Calgary, Alberta T2N 4Z6, Canada

Centre for Lung Health

Vancouver, British Columbia V5Z 1M9, Canada

St Pauls Hospital Pacific Lung Health Centre

Vancouver, British Columbia V6Z 1Y6, Canada

Dynamic Drug Advancement Limited

Ajax, Ontario L1S 2J5, Canada

Kanata Allergy Clinic

Ottawa, Ontario K2T 0N7, Canada

Centro de Investigacion Curico

Curicó, 3440000, Chile

Sociedad Medica SyG Limitada

Santiago, 7501126, Chile

Centro De Investigaciones Medicas Respiratorias

Santiago, 7750495, Chile

Icegclinic

Santiago, 8241479, Chile

Centro de Investigacion del Maule

Talca, 346000, Chile

Hefei First Peoples Hospital

Hefei, Anhui 230061, China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510150, China

The Third Peoples Hospital of Huizhou

Huizhou, Guangdong 516002, China

Hainan General Hospital

Haikou, Hainan 570311, China

Changsha Central Hospital

Changsha, Hunan 410004, China

The Second Hospital University of South China

Hengyang, Hunan 421001, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221006, China

Xuzhou Central Hospital

Xuzhou, Jiangsu 221009, China

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi 341000, China

Jiangxi Provincial Peoples Hospital

Nanchang, Jiangxi 330038, China

Pingxiang Peoples Hospital

Pingxiang, Jiangxi 337055, China

Heze Municipal Hospital

Heze, Shandong 274031, China

Huadong Hospital

Shanghai, Shanghai Municipality 200040, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi 030000, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang 321013, China

Corporacion Hospitalaria Juan Ciudad, Mederi

Bogota, Cundinamarca 11001, Colombia

Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo

Bogota, Cundinamarca 110221, Colombia

Mediservis del Tolima IPS SAS

Ibague, Tolima Department 730006, Colombia

MUDr I Cierna Peterova sro

Brandýs nad Labem-Stará Boleslav, 250 01, Czechia

Meditrial sro

Jindřichův Hradec, 377 01, Czechia

MUDr Josef Veverka

Rokycany, 337 01, Czechia

Kasmed sro

Tábor, 390 02, Czechia

Hong Kong Center for Clinical Research

Hong Kong, 999077, Hong Kong

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Edelenyi Koch Robert Korhaz es Rendelointezet

Edelény, 3780, Hungary

Erzsebet Gondozohaz

Gödöllő, 2100, Hungary

Puspokladanyi Egeszsegugyi Szolgaltato Intezmeny

Püspökladány, 4150, Hungary

Allergo-Fot Kft

Százhalombatta, 2440, Hungary

University of Fukui Hospital

Yoshida-gun, Fukui 910-1193, Japan

Medical corporation Syureikai Tohno Chuo Clinic

Mizunami-shi, Gifu 509-6134, Japan

Idaimae Minami Yojo Naika Clinic

Sapporo, Hokkaido 064-0804, Japan

Sakaide City Hospital

Sakaide-shi, Kagawa-ken 762-8550, Japan

Kamei Internal medicine and Respiratory Clinic

Takamatsu, Kagawa-ken 761-8073, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima-ken 890-8520, Japan

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa 231-8682, Japan

Yokohama City University Hospital

Yokohama, Kanagawa 236-0004, Japan

Kochi Medical School Hospital

Nankoku-shi, Kochi 783-8505, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka 560-8552, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo 173-8606, Japan

Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

Shinagawa-ku, Tokyo 140-8522, Japan

Centro de investigacion medico biologica y terapia avanzada

Guadalajara, Jalisco 44130, Mexico

cicum San Miguel

Guadalaja, Jalisco 44160, Mexico

Icaro Investigaciones en Medicina

Chihuahua City, 31000, Mexico

Unidad de Investigacion cima

Chihuahua City, 31200, Mexico

Centrum Medycyny Oddechowej Mroz Spolka Jawna

Bialystok, 15-044, Poland

Klimed Marek Klimkiewicz

Bychawa, 23100, Poland

GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero

Katowice, 40-600, Poland

Centrum Medyczne All-Med Badania kliniczne

Krakow, 30-033, Poland

Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

Krakow, 31-559, Poland

Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik Krzysztof Cudzik

Ostrowiec Świętokrzyski, 27-400, Poland

Ewa Springer Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

Poznan, 60-693, Poland

Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Wroclaw, 51-162, Poland

Spitalul de Pneumoftiziologie Bacau

Bacau, 600252, Romania

Spitalul de Pneumoftiziologie Leon Daniello

Cluj-Napoca, 400332, Romania

Spitalul Clinic de Boli Infecțioase si Pneumoftiziologie Victor Babes Craiova

Craiova, 200515, Romania

Medical Center

Deva, 330162, Romania

Spitalul Judetean de Urgenta Sf Ioan cel Nou Suceava

Suceava, 720224, Romania

Yeungnam University Medical Center

Daegu, 42415, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

The Catholic University of Korea Eunpyeong St Marys Hospital

Seoul, 03312, South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Konkuk University Medical Center

Seoul, 05030, South Korea

Asan Medical Center

Seoul, 05505, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Korea University Guro Hospital

Seoul, 08308, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

China Medical University Hospital

Taichung, 40447, Taiwan

Veterans General Hospital - Taichung

Taichung, 40705, Taiwan

Taipei Medical University Hospital

Taipei, 11031, Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Siriraj Hospital

Bangkok, 10700, Thailand

Songklanagarind Hospital

Songkhla, 90110, Thailand

Lakeside Healthcare

Corby, NN17 2UR, United Kingdom

CPS Research

Glasgow, G20 7BE, United Kingdom

Glasgow Royal Infirmary

Glasgow, G31 2ER, United Kingdom

4 Medical Clinical Solutions

Manchester, M27 8FF, United Kingdom

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom