RTX-GRT7039 Injections for Knee Osteoarthritis

No longer recruiting at 119 trial locations

Overseen By Director clinical trials

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Grünenthal GmbH

Disqualifiers: Joint replacement, Significant trauma, Hip osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new injection treatment called RTX-GRT7039 for individuals with painful knee osteoarthritis that hasn't improved with standard treatments. Participants will receive injections in one or both knees, depending on where they experience the most pain. The study seeks individuals diagnosed with knee osteoarthritis who aren't getting enough pain relief from their current care. Those who have had a joint replacement or significant knee surgery in the past year are not eligible to join. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RTX-GRT7039 is likely to be safe for humans?

Research has shown that RTX-GRT7039 is generally safe and well-tolerated. Studies found that single doses up to 8 mg were safe, with participants experiencing no major side effects. The treatment was tested on individuals aged 40 to 80, and the safety results were promising. Although some mild side effects might occur, the overall evidence suggests RTX-GRT7039 is safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for knee osteoarthritis, which often include pain relief medications and physical therapy, RTX-GRT7039 is unique due to its targeted approach. This experimental treatment involves injecting RTX-GRT7039 directly into the knee joint, which could offer more direct and potentially faster pain relief by acting precisely where the pain originates. Researchers are excited because it utilizes a new mechanism that may better address the root causes of pain and inflammation, potentially improving mobility and quality of life for patients with osteoarthritis.

What evidence suggests that RTX-GRT7039 might be an effective treatment for knee osteoarthritis?

Research has shown that RTX-GRT7039, the treatment under study in this trial, can effectively reduce pain in people with knee osteoarthritis. Studies have demonstrated that this treatment targets specific pain receptors, called TRPV1, to provide significant and lasting pain relief. Previous trials confirmed its safety and effectiveness in easing knee pain. Additionally, RTX-GRT7039 shows strong potential as a promising option for managing osteoarthritis pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments. They must be able to consent to the study and have a functional capacity class of I to III, based on specific medical criteria.

Inclusion Criteria

My previous treatments did not relieve my pain.

I have been diagnosed with knee osteoarthritis and can still perform daily activities.

The participant has given written informed consent to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of RTX-GRT7039 into the affected knee(s)

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RTX-GRT7039

Trial Overview The trial is testing RTX-GRT7039 injections for knee pain due to osteoarthritis. It's an open-label, single-arm study where all participants receive the treatment to assess its safety and tolerability.

How Is the Trial Designed?

Group I: RTX-GRT7039 Experimental Treatment 1 Intervention

Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.

Who Is Running the Clinical Trial?

Grünenthal GmbH

Lead Sponsor

Trials

99

Recruited

34,200+

Gabriel Baertschi

Grünenthal GmbH

Chief Executive Officer since 2016

Biology degree from the University of Neuchâtel

Prof. Dr. Uli Brödl

Grünenthal GmbH

Chief Medical Officer

MD from Ludwig-Maximilians University Munich

Published Research Related to This Trial

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, with 78% reporting improvement at week 1 compared to 49% in the placebo group.

The effectiveness of THA was particularly enhanced in patients with joint effusion and those who had synovial fluid aspirated during the injection, indicating that these factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Gaffney, K., Ledingham, J., Perry, JD.[2022]

Citations

1. ard.bmj.com ard.bmj.com/content/83/Suppl_1/667.2

POS1153 PRELIMINARY EVALUATION OF THE SAFETY ... Methods: The study was conducted as a randomized, double-blind, placebo-controlled, single-dose trial of RTX-GRT7039. Eligible patients were aged 40 to 80 years ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05248386

Efficacy and Safety of RTX-GRT7039 in Adult Subjects With ... A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of ...

3. acrabstracts.org acrabstracts.org/abstract/an-evaluation-of-the-efficacy-pharmacokinetics-and-safety-of-the-transient-receptor-potential-vanilloid-1-trpv1-agonist-rtx-grt7039-a-placebo-controlled-study-in-patients-with-osteoarthr/

An Evaluation of the Efficacy, Pharmacokinetics and Safety ... This early phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with KOA pain.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490358/

Intraarticular resiniferatoxin, a potent TRPV1 agonist, for ... The present assessments indicate that RTX has strong therapeutic promise to be an innovative approach to medical management of pain relief in osteoarthritis and ...

5. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-of-rtx-grt7039-in-adult-subjects-with-knee-osteoarthritis

Efficacy and Safety of RTX-GRT7039 in Adult Subjects With ... A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT05377489

Open-label Trial to Check the Safety and Tolerability of RTX ... An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients ...

7. oarsijournal.com oarsijournal.com/article/S1063-4584(24)00351-0/fulltext

Preliminary evaluation of the safety and analgesic effect ... RTX was found to be safe and well tolerated following single IA doses up to 8 mg (Euphorbia resinifera latex in the injectate solution) and with up to two ...

8. clinicaltrials.gov clinicaltrials.gov/show/NCT5377489

NCT5377489 | Open-label Trial to Check the Safety and ... An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in ...