Investigating NGI226 Microparticles for Achilles Tendinopathy
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
This study is testing if an injection of NGI226 microparticles can help people with stubborn Achilles tendinopathy feel better and improve their tendon strength.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 9 sites (Tucson, Arizona and 8 other locations) |
| Trial ID | NCT05592990 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, tolerability, and preliminary efficacy of NGI226 microparticles administered via a peritendon injection in patients suffering from mid-portion Achilles tendinopathy. Participants will receive either the NGI226 treatment or a placebo, and the study will measure improvements in tendon mechanical properties as well as any local or systemic side effects. The trial focuses on individuals whose condition has not improved after at least six weeks of conservative treatment. The results will help determine the potential of NGI226 as a therapeutic option for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults with clinically and imaging-confirmed mid-portion Achilles tendinopathy lasting between 8 to 12 months and who have not benefited from conservative treatments.
Not a fit: Patients with medical conditions that could compromise the safety of the injection or those with a history of recurrent infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with chronic Achilles tendinopathy who have not responded to standard therapies.
How similar studies have performed: While this approach is novel in the context of NGI226 microparticles, similar studies investigating other treatments for Achilles tendinopathy have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tucson, Arizona and 8 other locations
- Tucson Orthopedic Institute — Tucson, Arizona, United States (Recruiting)
- Advanced Research LLC — Deerfield Beach, Florida, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- Novartis Investigative Site — Caluire et Cuire, France (Recruiting)
- Novartis Investigative Site — Nantes Cedex 1, France (Withdrawn)
- Novartis Investigative Site — Berlin, Germany (Recruiting)
- Novartis Investigative Site — Hamburg, Germany (Recruiting)
- Novartis Investigative Site — Hamburg, Germany (Recruiting)
- Novartis Investigative Site — Glasgow, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.