NAMASTE study - Protocol number IZN-101
Research type
Research Study
Full title
A phase 2a proof of concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti-TNF therapy (NAMASTE study)
IRAS ID
244567
Contact name
Peter Taylor
Contact email
Sponsor organisation
Izana Bioscience Limited
Eudract number
2018-000176-15
Duration of Study in the UK
1 years, 4 months, 29 days
Research summary
The purpose of this study is to assess an investigational (experimental) study medication called Namilumab. It is being investigated for people who have axial spondyloarthritis (known as axSpA).
AxSpA is a rheumatic disease that causes back pain, stiffness, extreme tiredness, breathing and sleep problems and depression. These impact on daily activities and quality of life. The disease causes damage to, for example, the spine, leading to a change in posture, which can be painful and restrict movement.
Namilumab has been investigated by Takeda Pharmaceuticals (Takeda) as a treatment option for rheumatoid arthritis.
Participants who are eligible for this study will be between 18 and 75 years of age and diagnosed with axial spondyloarthritis (axSpA) more than 3 months ago.
The study will consist of a maximum 4-week Screening Period, followed by a 12-week double-blind treatment evaluation period, followed by a 16-week safety follow-up period, for a maximum study duration of approximately 32 weeks or 224 days per participant.This study will be conducted at UK sites - 8 study centres are expected to participate in this study.
Approximately 70 participants will be screened to achieve 42 participants randomly assigned to study treatment (36 on active treatment and 6 on placebo) and 42 evaluable participants for an estimated total of 36 evaluable participants on the active treatment arm and 6 evaluable participants in the placebo treatment arm.
Participants will have the option to participate in a sub-study where saliva samples will be collected.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0241
Date of REC Opinion
19 Jun 2018
REC opinion
Further Information Favourable Opinion