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

Launched by AMGEN · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called rocatinlimab to see how effective it is in reducing asthma flare-ups in adults with moderate to severe asthma. If you or a loved one have been diagnosed with asthma for at least a year and are currently using a medium to high dose of inhaled corticosteroids along with another asthma medication, you may be eligible to participate. Participants need to be between 18 and 75 years old and have experienced at least one asthma exacerbation in the past year.

If you join the trial, you will have the opportunity to try rocatinlimab and help researchers learn more about its effects on asthma symptoms. The study is currently recruiting participants, and those who are interested will undergo a screening process to ensure they meet the criteria. It's important to note that certain conditions, like recent severe asthma attacks or other significant health issues, may prevent someone from participating. This trial is a chance to contribute to important research while potentially benefiting from a new treatment option for asthma.

Gender

ALL

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.