Clinical trial NCT05592990: A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Achilles Tendinopathy
Keywords: Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of participants with AEs and SAEs
timeFrame: Up to Day 169 (End of Study)
Secondary outcomes:
measure: Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopedic Institute
state: Arizona
city: Deerfield Beach
country: United States
facility: Advanced Research LLC
state: Florida
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Caluire et Cuire
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References: