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

Achilles Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05592990
• Other study ID #: CNGI226A12201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 14, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Drug:
• NGI226
NGI226 MP
• Placebo
Placebo MP

Locations

Country	Name	City	State
France	Novartis Investigative Site	Caluire et Cuire
France	Novartis Investigative Site	Nantes Cedex 1
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Hamburg
United Kingdom	Novartis Investigative Site	Glasgow
United States	Advanced Research LLC	Deerfield Beach	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	Tucson Orthopedic Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with AEs and SAEs	AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability	Up to Day 169 (End of Study)
Secondary	Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)	To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon	Baseline, Week 12