*A FIH, randomized,double-blind,PK similarity study of SC AVT05, US licensed and EU approved Simponi
Research type
Research Study
Full title
A first-in-human, randomized, double-blind, single-dose, parallel-group design, 3-arm study to investigate the pharmacokinetic similarity, safety, tolerability, immunogenicity, and pharmacodynamics of subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in healthy adult participants
IRAS ID
1006304
Contact name
Roshan Dias
Contact email
Sponsor organisation
Alvotech Swiss AG
Eudract number
2022-003630-39
Clinicaltrials.gov Identifier
Research summary
Alvotech are developing a medicine called AVT05, which is similar to the US-licensed and EU-approved medicines “Simponi” (a brand name for the medication Golimumab). Simponi is biological medicine which is designed to block the function of a naturally occurring protein in the human body called tumor necrosis factor-α (TNF-α).
TNF-α is key to normal inflammatory and immune responses, however, it also plays a crucial role in the development many inflammatory diseases such as Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Crohn’s Disease (CD) an Ulcerative Colitis (UC). Therefore, medications which stop TNF-α from working (anti-TNF-α therapy) are an important treatment for these diseases.
The high cost of Simponi may stop some patients from being able to access the treatment, particularly as long-term use is often required. A similar product that provides comparable safety and effectiveness at a reduced cost would broaden the availability of this treatment to those who need it.
The primary purpose of this study is to demonstrate similarity between the way AVT05, US-licensed and EU-approved Simponi move through the body. We will also be assessing how safe and tolerable AVT05 is, how it is processed, broken down and excreted by the body, whether AVT05 provokes an immune response, and evaluate the ability of AVT05 to neutralise TNF-α.
This is the first time AVT05 has been studied in humans. This worldwide trial aims to include 336 healthy participants. Once a participant has been deemed safe to include they are randomly assigned to receive a single dose of either AVT05, US-licensed Simponi or EU-approved Simponi via an injection just under the skin. The trial lasts approximately 15 weeks. Participants will spend time as an inpatient where they will receive the medication and can be monitored for any side effects. Participants will return to the clinical trials unit at set intervals for outpatient appointments.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0659
Date of REC Opinion
3 Feb 2023
REC opinion
Further Information Favourable Opinion