A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma
a study on Asthma
Summary
- Eligibility
- for people ages 18-75 (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedcompletion around
Description
Summary
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
Keywords
Asthma, Moderate to severe asthma, Rocatinlimab, AMG 451, KHK4083
Eligibility
You can join if…
Open to people ages 18-75
- 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, 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 ≥ 40% and ≤ 80% 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 CAN'T join 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.
Locations
- University of California Irvine
accepting new patients
Orange California 92868 United States - NewportNativeMD, Inc
accepting new patients
Newport Beach California 92663 United States - Allianz Research Institute Westminster
accepting new patients
Westminster California 92683 United States - Imax Clinical Trials
accepting new patients
La Palma California 90623 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Amgen
- Links
- AmgenTrials clinical trials website
- ID
- NCT06376045
- Phase
- Phase 2 Asthma Research Study
- Study Type
- Interventional
- Participants
- Expecting 428 study participants
- Last Updated
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