RVLO 221-03 IRL2011805 in Uveitis
Research type
Research Study
Full title
A Prospective, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of IRL201805 in Participants with Noninfectious, Active, Intermediate, or Posterior Uveitis or Panuveitis.
IRAS ID
308700
Contact name
Carlos Pavesio
Contact email
Sponsor organisation
Revolo Biotherapeutics Ltd
Eudract number
2021-005755-37
Duration of Study in the UK
1 years, 8 months, 29 days
Research summary
The purpose of this research study is to learn about how noninfectious uveitis responds to IRL201805 when added to a stable dose of oral corticosteroid (e.g. prednisone), and to learn how and if the study medication will help people diagnosed with noninfectious uveitis with their disease.
IRL201805 is a drug designed to look like a protein that may play a role in regulating the immune system. It is not clear how IRL201805 works, but numerous animal studies show that the study drug appears to be effective in regulating the immune system from causing more long-term damage to tissue, similar to what happens in severe inflammatory diseases, such as uveitis. In addition to these animal studies, IRL201805 has also been studied in more than 20 people.
About 25 participants with active non-infectious uveitis and meeting other study entry criteria will receive IRL201805: 15 mg, 50 mg, or 100 mg (depending on the treatment cohort). Participants will be assigned to 1 of the 3 treatment cohorts in the order of their participation in the study.The study duration for participants is approximately 20 weeks:
• up to 30 days Screening to Randomization
• 12 weeks of evaluation of clinical response
• 4 weeks of safety follow up.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0084
Date of REC Opinion
5 May 2022
REC opinion
Further Information Favourable Opinion