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Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis

A Randomized, Two-arm, Placebo-controlled, Participant and Investigator-blinded Study Investigating the Efficacy, Safety and Tolerability of DFV890 in Patients With Symptomatic Knee Osteoarthritis

NCT04886258•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

Detailed Description

The purpose of the Phase 2a proof of concept study was to evaluate the safety and tolerability of DFV890 in participants with symptomatic knee OA, and to determine the efficacy of DFV890 in reducing knee pain as evidenced by change in KOOS (knee injury and osteoarthritis outcome score). The study had a screening period up to 45 days, a treatment period of 12 weeks and a 4-week follow-up period. At most, the study duration was 21 weeks.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants \>= 50 and \<= 80 years old on the day of Informed Consent signature.
•Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI = Body weight (kg) / \[Height (m)\]2
•High sensitivity C-reactive protein (hsCRP) \>=1.8 mg/L at screening
•Symptomatic OA with pain (corresponding to Numeric Rating Scale \[NRS\] 5-9, inclusive) in the target knee for the majority of days in the last 3 months prior to screening
•KOOS pain sub-scale score \<= 60 in index knee at screening and baseline
•Radiographic disease: K\&L grade 2 or 3 knee osteoarthritis in the target knee, confirmed by X-ray at screening.
•Active synovial inflammation at screening (defined a summary score of ≥7 with at least one region scoring 2) on contrast enhanced MRI (CE-MRI) of the whole knee for synovitis detection from 11 sites.

Exclusion Criteria

•Total WBC count \< 3,000/µL, absolute peripheral blood neutrophil count (ANC) \< 1,000/µL, hemoglobin \< 8.5 g/dL (85 g/L) or platelet count \< 100,000/µL at Screening
•Known autoimmune disease with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritis (gout, pseudogout associated arthritis), active acute or chronic infection or past infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia (widespread pain index, WPI, \>4 out of 19), or a known systemic connective tissue disease
•Any known active infections, including skin or knee infections or infections that may compromise the immune system, such as HIV or chronic hepatitis B or C infection. COVID-19 specific: PCR or antigen test against COVID-19 is mandatory where required by the local Health Authority and/or by local regulation, e.g. in Germany.
•Use of prohibited medications: any local i.a. treatment into the knee, including but not restricted to viscosupplementation and corticosteroids within 12 weeks prior to Day 1; long-term treatment (\>14 days) with oral corticosteroids \>5 mg/day within 4 weeks prior to Day 1; oral glucosamine, chondroitin sulfate, or any nutraceutical with potential activity on cartilage repairfrom screening 1; systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), selective Cyclooxygenase-2 (COX- 2) inhibitors or other non-opioid analgesics not defined as basic pain medication within 5 half-lives from PRO assessments; any other immunomodulatory drugs or treatment which cannot be discontinued or switched to a different medication within 28 days or 5 half-lives of screening (whichever is longer if required by local regulations), or until the expected PD effect has returned to baseline.
•Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to Screening, as per patient judgment.
•Severe malalignment greater than 7.5 degrees in the target knee (either varus or valgus), measured using x-ray at Screening.

Locations (31)

ARENSIA Explor Med Res Clinic

Phoenix, Arizona, United States

TriWest Reserach Associates

El Cajon, California, United States

Skylight Health Res Inc Color Spr

Colorado Springs, Colorado, United States

IRIS Research and Development

Plantation, Florida, United States

Conquest Research

Winter Park, Florida, United States

Ctr for Adv Research and Education

Gainesville, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Key Dates

Start Date

September 20, 2021

Primary Completion Date

December 14, 2024

Completion Date

December 23, 2024

Last Updated

January 28, 2026

Enrollment

115

ACTUAL participants

Conditions

Symptomatic Knee Osteoarthritis

Interventions

DFV890

DRUG

Placebo

DRUG

Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis

NCT03527693

Symptomatic Knee Osteoarthritis

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COMPLETEDNA

Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening

NCT01311206

Knee OsteoarthritisSymptomatic Knee Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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