RVLO 221-02 IRL201805 in rheumatoid arthritis
Research type
Research Study
Full title
A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis
IRAS ID
308691
Contact name
John Isaacs
Contact email
Sponsor organisation
Revolo Biotherapeutics Ltd
Eudract number
2021-005771-39
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
The purpose of this research study is to learn about how rheumatoid arthritis (RA) responds to study medicine IRL201805 when added to a stable dose of methotrexate, and to learn how and if the study medicine will help people diagnosed with RA with their disease.
The study medicine is not approved by any health authority for the use in clinical practice. It is not clear how IRL201805 works, but numerous animal studies show that the study medicine appears to be effective in regulating the immune system from causing more long-term damage to tissue, similar to what happens in severe inflammation diseases, such as RA. In addition to these animal studies, IRL201805 has also been studied in more than 20 people.The study will enroll up to 92 participants with moderately to severely active rheumatoid arthritis and on stable dose of methotrexate for RA and who meet other study inclusion criteria.
The main objectives of this research study are to:
• Learn how patients with RA respond to IRL201805.
• Learn more about how IRL201805 works and how safe it is.This research study is randomized and blinded. Approximately 92 participants will be randomized 3:1 to receive either IRL201805 or placebo. There are 3 dose levels of IRL201805 to which participants can be randomized: 15 mg, 50 mg or 100 mg.
There will be 2 parts of the study.
Part I will enroll about 12 participants in 3 cohorts (4 participants per cohort) to receive 3 doses of IRL201805 or placebo by IV bolus on Day 1, Week 4, and Week 8.
- Cohort 1: 15mg IRL201805 or placebo (randomization 3:1)
- Cohort 2: 50 mg IRL201805 or placebo (3:1)
- Cohort 3: 100 mg IRL201805 or placebo (3:1)
A safety and prespecified dose escalation criteria review by IDMC will occur between cohorts to assess safety and tolerability of IRL201805 before enrolment of the next dosing cohort will proceed. When safety review and dose-escalation criteria for Cohort 3 are met, Part II will open.Part II will enroll about 80 participants (20 participants per cohort) to receive 3 doses of IRL201805 or placebo by IV bolus on Day 1, Week 4, and Week 8:
- 15mg IRL201805 (20 participants), 50 mg IRL201805 (20 participants), 100 mg IRL201805 (20 participants), placebo (20 participants), 1:1:1:1.The study (including Part 1 and Part 2) will randomize approximately 92 participants to 3 doses of 15 mg, 50 mg, or 100 mg of IRL201805 or placebo.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0078
Date of REC Opinion
22 Mar 2022
REC opinion
Favourable Opinion