NCT05592990

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2023

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

October 20, 2022

Last Update Submit

March 26, 2026

Conditions

Achilles Tendinopathy

Keywords

Achilles tendon; mid-portion Achilles tendinopathy; peritendon injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)

    Baseline, Week 12

Study Arms (2)

NGI226

EXPERIMENTAL

single peritendon injection

Drug: NGI226

Placebo

PLACEBO COMPARATOR

single peritendon injection

Drug: Placebo

Interventions

NGI226DRUG

NGI226 MP

NGI226
PlaceboDRUG

Placebo MP

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Tucson Orthopedic Institute PC

Tucson, Arizona, 85712, United States

Location

Advanced Research LLC

Deerfield Beach, Florida, 33064, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Caluire-et-Cuire, 69300, France

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Hamburg, 20149, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

June 14, 2023

Primary Completion

February 3, 2026

Study Completion

February 3, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(3)DE(3)FR(1)