RTX-GRT7039 for Osteoarthritis

Recruiting at 110 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

450 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment to help people with knee osteoarthritis who still have pain despite other treatments. The treatment works by affecting the body's pain signals. The study will observe patients for up to a year to confirm its effectiveness and safety.

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.

How is the drug RTX-GRT7039 different from other osteoarthritis treatments?

RTX-GRT7039 is unique because it is being studied in a clinical trial specifically for its effects on osteoarthritis, and it is compared to a placebo to understand its effectiveness. Unlike some treatments that involve injections or physical therapy, this trial focuses on the potential benefits of RTX-GRT7039, which may offer a new approach to managing osteoarthritis symptoms. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors of Placebo Response to Local (Intra-Articular) Therapy In Osteoarthritis: An Individual Participant Data Meta-Analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Exercise therapy with or without other physical therapy interventions versus placebo interventions for osteoarthritis -Systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of pain and function placebo responses in pharmacological osteoarthritis trials. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis. [2022]