Last Update: Jun 17, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CNGI226A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of this study is to measure local and systemic safety and tolerability as
well as improvement of Achilles tendon mechanical properties after a single peritendon
injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles
tendinopathy.

Achilles Tendinopathy
Phase2
Recruiting
46
Jun 14, 2023
Jul 01, 2025
All
30 Years - 70 Years (Adult, Older Adult)

Interventions

Drug

NGI226

NGI226 MP
Drug

Placebo

Placebo MP

Eligibility Criteria

Inclusion Criteria:

- Written informed consent must be obtained prior to all study specific screening
procedures, as close to the start of the screening period as possible.

- Presence of clinically (local Achilles tendon pain on tendon-loading activities,
pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and
ultrasound (local tendon thickening with hypoechogenicities and irregular fibre
orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms
present ≥8 weeks but <12 months at screening.

- The Achilles tendinopathy must have been refractory to at least 6 weeks of
conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need
to be in physiotherapy at the time of study entry.

Exclusion Criteria:

- Medical condition that would affect safety of peritendon injection (e.g., peripheral
vascular disease, use of anticoagulant medication)

- History of recurrent, acute, symptomatic infections, including outbreaks of oral or
genital herpes (> 2 symptomatic infections or >2 courses of anti-infective
treatments required in the last 6 months; active systemic infection during last 2
weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple
cold excluded

- History or evidence of clinically significant cardiac or cardiovascular disease

- History of deep vein thrombosis, pulmonary embolism or evidence of primary or
secondary hypercoagulable states

- History of surgical intervention for the treatment of tendinopathy, history of ankle
surgery, ankle arthritis, traumatic, inflammation or deformity of ankle

- History of full-thickness tear or complete rupture of the Achilles tendon

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

Novartis Pharmaceuticals