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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05592990

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

26.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendinopathy	Drug: NGI226 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 23, 2023

Anticipated Primary Completion Date :

Feb 21, 2025

Anticipated Study Completion Date :

Feb 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NGI226 single peritendon injection	Drug: NGI226 NGI226 MP
Placebo Comparator: Placebo single peritendon injection	Drug: Placebo Placebo MP

Arm

Intervention/Treatment

Experimental: NGI226

single peritendon injection

Drug: NGI226

NGI226 MP

Placebo Comparator: Placebo

single peritendon injection

Drug: Placebo

Placebo MP

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tucson Oprthopedic Institute	Tucson	Arizona	United States	85712
2	Advanced Research LLC	Coral Springs	Florida	United States	33067

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05592990

Other Study ID Numbers:

CNGI226A12201

First Posted:

Oct 25, 2022

Last Update Posted:

Nov 28, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection

Additional relevant MeSH terms:

Tendinopathy

Study Results

No Results Posted as of Nov 28, 2022