Safety, tolerability and preliminary efficacy of NGI226 microparticles in Achilles tendinopathy
Research type
Research Study
Full title
A two part, randomized, participant and investigator-blinded, 2-arm, parallel-design, placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of NGI226 microparticles on tendon regeneration in patients with Achilles tendinopathy
IRAS ID
1006018
Contact name
Katharina Boehm
Contact email
Sponsor organisation
Novartis Pharma Arzneimittel GmbH
Eudract number
2022-500863-10-00
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to learn more about a drug treatment called NGI226 microparticles (MP). This study will tell us how this treatment works, and whether it is safe and well tolerated in participants with Achilles tendinopathy.
Achilles tendinopathy is an injured tendon condition that causes pain and swelling and decreased strength and movement. NGI226 acts on proteins called Janus kinases, which when activated may play a role in tendinopathy. By preventing activation of these Janus kinases, NGI226 may be able to improve tendon structure and function and thereby relieve the symptoms of tendinopathy. It is given as an injection into the leg near the Achilles tendon.
This research study consists of two parts: A and B. In Part A, we will assess the tolerability and safety of 4 different doses of NGI226. About 16 participants, split in four groups of 4, will take part. In each group 3 participants will receive active treatment NGI226 MP and 1 participant will receive placebo MP (a dummy treatment with no active drug). The first group will receive the lowest dose of NGI226 MP. If this is safe and well-tolerated, the next group will receive a higher dose.
In Part B we will use the highest safe dose from Part A and assess the efficacy on the quality and composition of tendon healing in a group of 30 participants. In this group 20 participants will receive NGI226 MP and 10 will receive placebo MP.
Approximately 46 male and female participants, 30 to 70 years old, with an ultrasound or MRI confirmed diagnosis of Achilles tendinopathy in the middle part of the Achilles tendon will be enrolled in 5 countries. In the UK there will be two sites and approximately 10 participants will be enrolled. Participation will last about 7 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/FT/0111
Date of REC Opinion
10 Jan 2023
REC opinion
Further Information Favourable Opinion