Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Irvine
Dates
study started
completion 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
  • Orso Health Inc accepting new patients
    La Jolla California 92037 United States
  • NewportNativeMD, Inc accepting new patients
    Newport Beach California 92663 United States
  • Downtown Los Angeles Research Center, Inc accepting new patients
    Los Angeles California 90017 United States
  • Apex Clinical Research accepting new patients
    San Diego California 92120 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
  • Allergy and Asthma Clinical Research accepting new patients
    Walnut Creek California 94598 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