CAPS Study
Research type
Research Study
Full title
A Multi-Centre, Randomised, Open-Label, Phase IIb Study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin Associated Periodic Syndromes
IRAS ID
281821
Contact name
Helen Lachmann
Contact email
Sponsor organisation
Inflazome (Australia) Pty Ltd.
Eudract number
2020-000489-40
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Cryopyrin-Associated Periodic Syndrome (CAPS) is an autoinflammatory disease, (this means you have problems with your immune system). It happens when immune cells attack the body by mistake. This results in inflammation, which causes the symptoms of the disease.
Current CAPS treatments are injected and can therefore can cause pain, other side effects, and require specialist training for caregivers to provide the treatment. This research study, sponsored by Inflazome (Australia) Pty Ltd., will test the safety, tolerability and efficacy of the new study medication, IZD174, in participants with CAPS, aged 18 to 75 years. IZD174 capsules are taken orally (taken by mouth with water).
Participants in this study will be randomly separated into 2 groups to find which dose of IZD174 works the best.
Participants will attend 9 visits over about 4 months, one of these visits will be a 4 to 16 day stay at the study centre.
Approximately 14 participants from 3 study centres in Australia, Ireland and UK will participate in this research.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
20/LO/0885
Date of REC Opinion
22 Sep 2020
REC opinion
Further Information Favourable Opinion