Open-label trial to check the safety and tolerability of RTX-GRT7039 injections for pain associated with osteoarthritis of the knee.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gruenenthal GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

26 Jul 2022 → 15 May 2025

Decision date (initial)

2024-11-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-515709-24-00

EudraCT number

2021-005046-15

WHO UTN

U1111-1268-7230

ClinicalTrials.gov

NCT05377489

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To assess the safety and tolerability of intra-articular RTX-GRT7039.

Secondary objectives 3

1. To assess the safety of intra-articular RTX-GRT7039 with regard to structural changes.
2. Investigate the analgesic effectiveness of intra-articular RTX-GRT7039 - index knee and non-index knee (if applicable).
3. Evaluate the quality of life after treatment with RTX-GRT7039.

Conditions and MedDRA coding

Moderate to severe pain associated with Osteoarthritis of the knee

Regulatory references

Scientific advice from competent authorities

Federal Agency For Medicines And Health Products, European Medicines Agency, Federal Institute For Drugs And Medical Devices

Plan to share IPD

Yes

IPD plan description

Information available on the Grünenthal Group Web Site and according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. ≥ 18 years of age at the screening visit.
2. Body Mass Index (BMI) ≤ 40.0 kg/m2.
3. Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
4. Moderate to severe osteoarthritis at baseline.
5. Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC).
6. The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient's pain treatment.

Exclusion criteria 8

1. The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within one month.
2. The subject had an injection of platelet-rich plasma into the index knee within one month.
3. The subject applied topical capsaicin on the index knee within 3 months.
4. Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis. Presence of these medical conditions has to be evaluated based on medical history and X-ray assessed by Central Readers, performed during Screening.
5. Other conditions that could confound discrimination of pain assessment in the index knee.
6. Clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of the trial.
7. History of severe allergic or anaphylactic reactions.
8. History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation.

Secondary endpoints 3

1. Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI]).
2. Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score for the index and the non-index (where applicable) knee.
3. Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36.

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gruenenthal GmbH

Sponsor organisation

Gruenenthal GmbH

Address

Zieglerstrasse 6

City

Aachen

Postcode

52078

Country

Germany

Scientific contact point

Organisation

Gruenenthal GmbH

Contact name

Grünenthal Trial Information Desk

Public contact point

Organisation

Gruenenthal GmbH

Contact name

Grünenthal Trial Information Desk

Third parties 6

Locations

3 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 20 files

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

Application history

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