DFV890 for Knee Osteoarthritis

Recruiting at 24 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

115 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing a new medication called DFV890 to see if it can help people with painful knee osteoarthritis. The study will check if the medication can reduce knee pain and improve how well the knee works. Participants will be monitored for safety and how well they tolerate the medication.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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