A Phase 3 Study of Rocatinlimab in Participants with Prurigo Nodularis
Research type
Research Study
Full title
A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
IRAS ID
1010257
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-510753-10
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 study, the late stage of the development process of medicines for humans. Researchers will check and provide information on how well rocatinlimab works and how well a person tolerates it when compared with placebo to treat PN (Prurigo Nodularis) and whether it causes any side effects. Neither the participants nor the study doctors will know which study product each participant is given until after the study is over. This is done to make sure the study results were not influenced in any way. The study may last up to 68 weeks for each participant, including a screening period of up to 4 weeks, a 52-week treatment period, and a safety follow-up visit 16 weeks after the last dose of rocatinlimab at week 48.
REC name
West of Scotland REC 1
REC reference
24/WS/0124
Date of REC Opinion
17 Oct 2024
REC opinion
Further Information Favourable Opinion