RTX-GRT7039 Injection for Osteoarthritis

No longer recruiting at 97 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

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 tests a new injection, RTX-GRT7039, to determine if it can reduce knee pain from osteoarthritis when other treatments have been insufficient. Participants will receive either the RTX-GRT7039 injection or a placebo, which resembles the treatment but lacks the active ingredient, to compare effects. It targets individuals diagnosed with knee osteoarthritis who continue to experience significant pain despite standard treatments. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment option.

Do I need to stop my current medications for the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RTX-GRT7039 is generally safe for humans. Studies have found it well tolerated when injected into the knee joint. In earlier trials, patients experienced minimal side effects. Specifically, research indicates that single doses of RTX-GRT7039, ranging from 0.25 to 2 mg, were safe and well tolerated. So far, trials suggest this treatment can effectively manage osteoarthritis pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for osteoarthritis, which typically include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections, RTX-GRT7039 offers a novel approach. This treatment is exciting because it uses an intra-articular injection to deliver a new active ingredient directly into the joint, potentially providing more targeted relief. Researchers are particularly interested in RTX-GRT7039 because it may offer longer-lasting pain relief without the systemic side effects often associated with oral medications. By targeting the pain directly at its source, RTX-GRT7039 represents a promising new option for managing osteoarthritis symptoms.

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

Research has shown that RTX-GRT7039, which participants in this trial may receive, may help reduce pain for people with osteoarthritis. In one study, patients who took RTX-GRT7039 reported more pain relief than those who took a placebo, a treatment with no active medicine. Another study found that many patients experienced significant pain relief, with pain scores dropping by 50% to 70%. RTX-GRT7039 targets a part of the body involved in sending pain signals, which might explain its effectiveness. Overall, early results suggest that RTX-GRT7039 could be an effective long-term treatment for osteoarthritis pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments can join. They must understand and agree to the trial's process. Excluded are those with severe joint damage, past knee surgery within a year, significant leg misalignment, other conditions affecting safety or results, recent participation in another drug trial, employees involved in the study, clinical hip osteoarthritis on the same side, or allergy to resiniferatoxin.

Inclusion Criteria

You have tried the usual treatments for your pain, but they did not work well enough for you.

The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.

The participant has given written informed consent to participate.

Exclusion Criteria

You have certain existing bone conditions or severe knee pain that is not caused by osteoarthritis.

You have hip osteoarthritis on the same side as your knee condition.

The participant has past joint replacement surgery of the index knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of RTX-GRT7039 or placebo during the 52-week double-blind treatment period

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RTX-GRT7039

Trial Overview The trial is testing RTX-GRT7039 against a placebo for knee osteoarthritis pain relief. Participants will receive one injection and be randomly assigned to either the treatment or placebo group without knowing which they received (double-blind). The goal is to confirm if RTX-GRT7039 is effective and safe.

How Is the Trial Designed?

Group I: RTX-GRT7039 Experimental Treatment 1 Intervention

Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.

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

Citations

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

POS1153 PRELIMINARY EVALUATION OF THE SAFETY ... Subjects receiving RTX reported a greater pain reduction than subjects receiving placebo. At the 3 months visit, there was a higher mean [SD] absolute reduction ...

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 ... Responder analyses revealed a higher percentage of subjects with ≥50% or ≥70% reduction in VAS scores for pain on motion across all RTX-GRT7039 treatment groups ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT05449132

Comparison of a Single RTX-GRT7039 and Placebo Intra ... Participants will receive a single intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period. Interventions.

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

Intraarticular resiniferatoxin, a potent TRPV1 agonist, for ... So far, all of the trials suggest that intraarticular administration of RTX is a safe and highly effective, long-duration treatment for osteoarthritis pain. 2.

6. oarsijournal.com oarsijournal.com/article/S1063-4584(24)00352-2/fulltext

Evaluation of the safety and analgesic effect of the TRPV1 ... RTX was safe and well tolerated following single IA doses (0.25 to 2 mg; Euphorbia resinifera latex in the injectate solution).

7. 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 ...