A study to investigate the safety, tolerability and preliminary efficacy of NGI226 microparticles in patients with Achilles tendinopathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

18 Oct 2023 → 4 Feb 2026

Decision date (initial)

2022-12-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG, OMS ID: ORG-100003908

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

To assess the local and systemic safety and tolerability of a single peritendon injection of NGI226 MP in patients with mid-portion Achilles tendinopathy

Secondary objectives 1

1. To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon (AT)

Conditions and MedDRA coding

Achilles Tendinopathy

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Written informed consent prior to all study specific screening procedures must be obtained
2. Adults 30 to 70 years of age (both inclusive)
3. 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
4. Ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI (Magnetic Resonance Imaging) diagnosed mid-portion Achilles tendinopathy
5. Symptoms present ≥8 weeks but <12 months
6. Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDs (Non Steroidal Anti Inflammatory Drugs), Rest Ice Compression Elevation (RICE))

Exclusion criteria 6

1. Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication)
2. 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
3. History or evidence of clinically significant cardiac or cardiovascular disease
4. History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states
5. History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle
6. History of full-thickness tear or complete rupture of the Achilles tendon

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Part A and Part B: • Local and systemic treatment Emergent Adverse Events (TEAEs) and serious TEAEs • Local tolerability (changes in pain, swelling, redness, warmth, range of motion and itching, infection, tendon physical examination) • Laboratory tests (clinical chemistry, hematology, coagulation, Liver Function Test (LFT), urinalysis) • Electrocardiogram parameters (ECGs) • Vital signs (blood pressure, pulse rate, body, temperature)

Secondary endpoints 1

1. Part A and Part B: Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel Town

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 9

Locations

3 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications