RTX-GRT7039 for Osteoarthritis

No longer recruiting at 139 trial locations

Overseen By Director clinical trials

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Grünenthal GmbH

Disqualifiers: Joint replacement, Trauma, Hip osteoarthritis, Osteonecrosis, 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 aims to determine if repeated injections of RTX-GRT7039 can reduce knee pain in individuals with osteoarthritis when standard treatments prove insufficient. Participants will receive either the actual treatment or a placebo (a substance with no therapeutic effect) over a year to compare results. The study seeks individuals with knee osteoarthritis who have tried standard treatments without sufficient relief and have not undergone knee replacement surgery. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for knee osteoarthritis.

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 team or your doctor.

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

Research shows that RTX-GRT7039 is generally safe and well-tolerated. Previous studies have found it has a good safety record. Participants using RTX-GRT7039 have not reported major side effects, indicating serious issues are rare. Trials suggest this treatment is a safe option for managing osteoarthritis pain.

In these studies, researchers administered RTX-GRT7039 as injections into the joint, and most people handled this well. These findings are encouraging for those considering joining a trial, as they suggest the treatment usually does not cause harmful side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often involve oral pain relievers or topical creams, RTX-GRT7039 is unique because it is delivered directly into the joint through an injection. This direct approach allows the treatment to target the pain at its source more effectively. Researchers are excited about RTX-GRT7039 because it has a novel mechanism of action that could potentially offer longer-lasting relief from pain compared to traditional treatments. By focusing on this innovative delivery method and mechanism, RTX-GRT7039 could provide a new level of comfort and mobility for those suffering from osteoarthritis.

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 from osteoarthritis. In earlier studies, people who took RTX-GRT7039 reported more pain relief than those who took a placebo. For instance, many participants felt their pain drop by 50% or more. Another study found that RTX-GRT7039 was a safe and effective long-term treatment for osteoarthritis pain. Overall, these findings suggest that RTX-GRT7039 could help reduce knee pain in osteoarthritis patients who haven't found relief with standard treatments. ^{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 meet specific criteria for the severity of their condition and not have other knee issues or sensitivities to components like capsaicin. Recent surgery, significant trauma, or participation in another drug trial disqualifies them.

Inclusion Criteria

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.

You have tried the standard treatment for your pain before, but it didn't work well enough for you.

The participant has given written informed consent to participate.

Exclusion Criteria

You have other health conditions that could make it difficult to evaluate the condition of your knee during the trial.

The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10, valgus >10) by X-ray as assessed by independent Central Readers at Screening Visit.

The participant has current 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 participant's participation for the full duration of the trial.

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 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 in patients with knee osteoarthritis pain. Participants will receive repeated injections to see if it's effective and safe compared to no active treatment. The study randomly assigns participants to either the test drug or placebo group without them knowing which one they're getting.

How Is the Trial Designed?

Group I: RTX-GRT7039 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Participants will receive intra-articular injections of placebo matching to 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 ...