ACTIVE_NOT_RECRUITING

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

Conditions

Asthma Moderate to severe asthma Rocatinlimab AMG 451 KHK4083

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

Quick Facts

Study Start:2024-05-24

Study Completion:2026-12-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06376045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

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, 79106

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

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24

Study Completion Date2026-12-14

Study Record Updates

Study Start Date2024-05-24

Study Completion Date2026-12-14

Terms related to this study

Keywords Provided by Researchers

Moderate to severe asthma
Rocatinlimab
AMG 451
KHK4083

Additional Relevant MeSH Terms

Asthma