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

NCT06376045

CompletedPhase 2

Sponsor: Amgen

Conditions: Asthma

Interventions: Rocatinlimab, Placebo

Countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (154)
  • Bakersfield, California, United States
  • La Jolla, California, United States
  • La Palma, California, United States
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Westminster, California, United States
  • Clearwater, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Columbus, Georgia, United States
  • Boise, Idaho, United States
  • Normal, Illinois, United States
  • Louisville, Kentucky, United States
  • White Marsh, Maryland, United States
  • Detroit, Michigan, United States
  • Ypsilanti, Michigan, United States
  • Saint Charles, Missouri, United States
  • Missoula, Montana, United States
  • Lincoln, Nebraska, United States
  • Union City, New Jersey, United States
  • New Hyde Park, New York, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • + 124 more on CT.gov