A Phase 2 Study of Rocatinlimab in Moderate-to-severe Asthma in Adults
Research type
Research Study
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.
IRAS ID
1009571
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2023-508039-29
Clinicaltrials.gov Identifier
Research summary
Asthma is a condition that affects your airways, the tubes that carry air in and out of your lungs. In asthma, the airways become swollen and narrow which makes it harder for air to flow in or out of your lungs when you breathe.
This is a phase 2 study, the second part of the development of medicines for humans. Researchers will check and provide information on how well rocatinlimab works and if it is tolerable when compared with placebo (an inactive substance that looks the same and is given the same way as rocatinlimab) to treat moderate-to-severe asthma. The study will also test different doses of rocatinlimab to establish which dose works best and/or is least harmful and whether it causes any side effects.
Neither the participants nor the study doctor can choose the study drug the participants will get. Participants agree to be put into a treatment group by chance (“randomised”). This is like flipping a coin or drawing numbers out of a hat.
The study may last up to 62 weeks for each participant, including a screening period of up to 2 weeks, a 28 (±3) day run-in baseline period, a 48 week blinded treatment period, and a safety follow-up visit, 16 weeks after the last dose of rocatinlimab.REC name
London - South East Research Ethics Committee
REC reference
24/LO/0533
Date of REC Opinion
12 Aug 2024
REC opinion
Further Information Favourable Opinion