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

NCT ID: NCT04886258

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2024-12-23

Brief 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.

Conditions

Symptomatic Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DFV890

DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.

Group Type: EXPERIMENTAL

DFV890

Intervention Type: DRUG

DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.

Placebo

Matching Placebo was administered orally twice per day during 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo was administered orally twice per day during 12 weeks.

Interventions

DFV890

DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.

Intervention Type: DRUG

Placebo

Matching Placebo was administered orally twice per day during 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Novartis Investigative Site

Brno, Czech Republic, Czechia

Novartis Investigative Site

Nový Jičín, , Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Uherské Hradiště, , Czechia

Novartis Investigative Site

Bad Doberan, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Leipzig, , Germany

Novartis Investigative Site

Kecskemét, Bács-Kiskun county, Hungary

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Miskolc, , Hungary

Novartis Investigative Site

Veszprém, , Hungary

Novartis Investigative Site

Cluj-Napoca, Cluj, Romania

Novartis Investigative Site

Bucharest, , Romania

Novartis Investigative Site

Nové Mesto nad Váhom, , Slovakia

Novartis Investigative Site

Piešťany, , Slovakia

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

A Coruña, , Spain

Novartis Investigative Site

Seville, , Spain

Countries

United States; Argentina; Czechia; Germany; Hungary; Romania; Slovakia; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-006104-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDFV890B12201

Identifier Type: -

Identifier Source: org_study_id