AMGEN AMG-451 (Moderate-to-Severe Asthma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called rocatinlimab (the study drug) is a safe and effective option for people who have moderate or severe asthma. We want to know if it can reduce symptoms and the severity of asthma exacerbations for people who take it.

What is the Condition Being Studied?

Asthma

Who Can Participate in the Study?

Adults ages 18-75 who:

  • Are diagnosed with asthma for at least one year
  • Are currently taking an inhaled therapy for asthma symptoms
  • Have had at least one asthma exacerbation in the past 12 months, requiring the use of systemic corticosteroids

For more information about who can join this study, please contact the study team at DukeAirwayResearch@duke.edu or 919-479-0861.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • Complete a screening period (up to 2 weeks), which will include breathing tests, ECG, FeNO, and a blood draw
  • If eligible, begin a 48-week study drug period and get a random assignment (like a coin flip) to take either the study drug or placebo
  • Visit our clinic up to 15 times throughout the study (including screening visit)

Study Details

Full 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
Principal Investigator
Pulmonologist
Protocol Number
IRB: PRO00115602
NCT: NCT06376045
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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