DFV890 for Knee Osteoarthritis

No longer recruiting at 36 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Corticosteroids, NSAIDs, COX-2 inhibitors, others

Disqualifiers: Autoimmune diseases, Infections, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: 21

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DFV890 for knee osteoarthritis to see if it reduces pain and inflammation. It involves two groups: one receiving DFV890 and the other a placebo, a harmless pill that resembles the treatment but has no effect. The trial aims to determine the safety and effectiveness of DFV890 for individuals with ongoing knee pain. Those who have experienced knee pain most days over the last three months and have been diagnosed with knee osteoarthritis might qualify for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. You must not have had local treatments like viscosupplementation or corticosteroids in the knee within 12 weeks before starting, and you need to stop certain pain medications and immunomodulatory drugs within a specific time frame before screening.

Is there any evidence suggesting that DFV890 is likely to be safe for humans?

Research has shown that DFV890 has undergone previous studies. In one study, researchers tested the safety and tolerability of DFV890 in humans for the first time. The study found that participants generally tolerated DFV890 well, with most side effects being mild to moderate.

DFV890 is now in a phase 2 trial, and earlier trials have already provided some safety information. This indicates that the treatment is considered safe enough for more detailed testing. However, new side effects could still emerge.

For those considering joining this trial, it is reassuring that DFV890 has been generally safe in past studies. Nonetheless, discussing any concerns with a doctor is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

DFV890 is unique because it targets inflammation pathways in knee osteoarthritis differently than current treatments. While most treatments, like NSAIDs or corticosteroids, focus on reducing pain and inflammation through generalized mechanisms, DFV890 is designed to specifically inhibit certain inflammatory processes at the molecular level. This targeted approach not only has the potential to be more effective but may also result in fewer side effects, making it a promising option for individuals seeking relief from knee osteoarthritis. Researchers are excited about DFV890 because it represents a novel approach that could significantly improve the quality of life for patients with this condition.

What evidence suggests that DFV890 might be an effective treatment for knee osteoarthritis?

Research shows that DFV890, which participants in this trial may receive, might help treat knee osteoarthritis. Early studies have shown DFV890 to be promising in easing pain linked to this condition. Taken orally, the pill was safe and well-tolerated in initial trials. Although still under study, results suggest that DFV890 could reduce pain and improve knee movement. As research continues, scientists remain hopeful about its potential benefits for people with knee osteoarthritis. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 50-80 with knee osteoarthritis, pain in the target knee for most days over the past 3 months, and certain levels of inflammation as shown by blood tests and MRI. They must weigh at least 50 kg with a BMI of 18-35 kg/m2. Excluded are those with other arthritis types, severe malalignment in their knee, certain blood disorders or infections, or using prohibited medications.

Inclusion Criteria

Are you able to undergo an MRI examination with IV contrast (paid for by the study)?

Are you between the ages of 50 and 80?

Do you have mild to moderate knee pain due to osteoarthritis?

Exclusion Criteria

Have you had a partial or total knee replacement?

Have you had any other knee surgery on either knee within the past 6 months?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DFV890 or placebo to assess efficacy, safety, and tolerability in reducing knee pain

12 weeks

Visits at baseline, week 2, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Final visit at week 19

What Are the Treatments Tested in This Trial?

Interventions

• DFV890
• Placebo

Trial Overview The trial is testing DFV890's effectiveness compared to a placebo in reducing symptoms of knee osteoarthritis. Participants will be randomly assigned to receive either DFV890 or a placebo without knowing which one they're getting (double-blinded). The study spans up to 21 weeks including screening, treatment, and follow-up periods.

How Is the Trial Designed?

Group I: DFV890 Active Control 1 Intervention

DFV890

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04886258

NCT04886258 | Study of Efficacy, Safety and Tolerability of ... This is a double-blinded, two-arm, phase II study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11101992/

First‐in‐human safety, tolerability, and pharmacokinetic ... The safety and tolerability, PK, and PD results suggest that DFV890 has the potential to be a clinically effective and orally available direct ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT04886258

Study of Efficacy, Safety and Tolerability of DFV890 in Patients ... This is a double-blinded, two-arm, phase II study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04886258/study-of-efficacy-safety-and-tolerability-of-dfv890-in-patients-with-knee-osteoarthritis

Study of Efficacy, Safety and Tolerability of DFV890 in ... This is a double-blinded, two-arm, phase II study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-dfv890-for-pain-relief-in-patients-with-knee-osteoarthritis/

Study on the Effects of DFV890 for Pain Relief in Patients ... This clinical trial investigates the efficacy of DFV890, a film-coated tablet, in relieving pain associated with knee osteoarthritis.