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

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

Loretta
Que

Protocol Number

PRO00115602

NCT ID

NCT06376045

Phase

II

Enrollment Status

Open to Enrollment