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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT06376045

Run by

Amgen

People needed

317

Starts

2024-05-24

Expected to finish

2026-06-23

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orso Health Inc — La Jolla, California, United States
• Imax Clinical Trials — La Palma, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• Downtown Los Angeles Research Center, Inc — Los Angeles, California, United States
• NewportNativeMD, Inc — Newport Beach, California, United States
• University of California Irvine — Orange, California, United States
• Apex Clinical Research — San Diego, California, United States
• Allergy and Asthma Clinical Research — Walnut Creek, California, United States
• Allianz Research Institute Westminster — Westminster, California, United States
• St Francis Medical Institute — Clearwater, Florida, United States
• BioMed Research Institute — Miami, Florida, United States
• Bright Research Center LLC — Miami, Florida, United States
• Infinity Life Research Group — Tamarac, Florida, United States
• Clinical Research Trials of Florida Inc — Tampa, Florida, United States
• AllerVie Clinical Research- Columbus — Columbus, Georgia, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Sneeze, Wheeze, and Itch Associates, LLC — Normal, Illinois, United States
• Family Allergy and Asthma Research Institute — Louisville, Kentucky, United States
• Chesapeake Clinical Research Inc — White Marsh, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Respiratory Medicine Research Institute of Michigan, plc — Ypsilanti, Michigan, United States
• Midwest Chest Consultants, PC — Saint Charles, Missouri, United States
• Montana Medical Research — Missoula, Montana, United States
• Somnos Clinical Research — Lincoln, Nebraska, United States
• Kern Research Inc — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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