A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

Phase 2

Recruiting

• Conditions: Achilles Tendinopathy
• Interventions: Drug: NGI226; Drug: Placebo

• Registration Number: NCT05592990
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Study Start: 2023-06-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-12-03
• Study Completion: 2025-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NGI226	NGI226	single peritendon injection
Placebo	Placebo	single peritendon injection

Primary Outcome Measures

Name	Time	Method
Number of participants with AEs and SAEs	Up to Day 169 (End of Study)	AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability

Secondary Outcome Measures

Name	Time	Method
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)	Baseline, Week 12	To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon

Trial Locations

Locations (4)

Tucson Orthopedic Institute; 🇺🇸 Tucson, Arizona, United States

Advanced Research LLC; 🇺🇸 Deerfield Beach, Florida, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Novartis Investigative Site; 🇬🇧 Glasgow, United Kingdom