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

Last updated: February 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Osteoarthritis

Treatment

Placebo

DFV890

Clinical Study ID

NCT04886258
CDFV890B12201
2020-006104-17
  • Ages 50-80
  • All Genders

Study Summary

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

The study includes a screening period, a treatment period and a follow-up period. At most, the study duration is 21 weeks.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male and female participants >= 50 and <= 80 years old on the day of InformedConsent signature.

  • Participants must weigh at least 50 kg to participate in the study, and must have abody mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI = Bodyweight (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 toscreening

  • 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 atleast one region scoring 2) on contrast enhanced MRI (CE-MRI) of the whole knee forsynovitis detection from 11 sites.

Exclusion

Key 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 torheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupuserythematosus), crystal-induced arthritis (gout, pseudogout associated arthritis),active acute or chronic infection or past infection of the knee joint, Lyme diseaseinvolving the knee, reactive arthritis, systemic cartilage disorders, moderate tosevere fibromyalgia (widespread pain index, WPI, >4 out of 19), or a known systemicconnective tissue disease

  • Any known active infections, including skin or knee infections or infections thatmay 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 requiredby 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 butnot restricted to viscosupplementation and corticosteroids within 12 weeks prior toDay 1; long-term treatment (>14 days) with oral corticosteroids >5 mg/day within 4weeks prior to Day 1; oral glucosamine, chondroitin sulfate, or any nutraceuticalwith potential activity on cartilage repairfrom screening 1; systemic Non-SteroidalAnti-Inflammatory Drugs (NSAIDs), selective Cyclooxygenase-2 (COX- 2) inhibitors orother non-opioid analgesics not defined as basic pain medication within 5 half-livesfrom PRO assessments; any other immunomodulatory drugs or treatment which cannot bediscontinued or switched to a different medication within 28 days or 5 half-lives ofscreening (whichever is longer if required by local regulations), or until theexpected PD effect has returned to baseline.

  • Moderate to severe pain in the contralateral knee for the majority of days in thelast 3 months prior to Screening, as per patient judgment.

  • Severe malalignment greater than 7.5 degrees in the target knee (either varus orvalgus), measured using x-ray at Screening

Study Design

Total Participants: 115
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 20, 2021
Estimated Completion Date:
December 23, 2024

Study Description

The purpose of the Phase 2a proof of concept study is 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).

Connect with a study center

  • Novartis Investigative Site

    Caba, Buenos Aires C1181ACH
    Argentina

    Site Not Available

  • Novartis Investigative Site

    San Miguel de Tucuman, Tucuman T4000CBC
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Tucuman, 4000
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Brno, Czech Republic 66250
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Novy Jicin, 741 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha 2, 128 50
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • Novartis Investigative Site

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10787
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01069
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 22415
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04107
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kecskemet, Bacs Kiskun 6044
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Tata, Komarom Esztergom 2890
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Budapest, 1027
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Eger, 3300
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Gyor, H-9024
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Miskolc, H-3526
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, 6720
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Veszprem, 8200
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Cluj Napoca, Cluj 400006
    Romania

    Site Not Available

  • Novartis Investigative Site

    Bucharest, 011658
    Romania

    Site Not Available

  • Novartis Investigative Site

    Martin, 036 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Nove Mesto nad Vahom, 91501
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Piestany, 92101
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Santiago De Compostela, A Coruna 15705
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08003
    Spain

    Site Not Available

  • Novartis Investigative Site

    La Coruna, Galicia 15006
    Spain

    Site Not Available

  • Novartis Investigative Site

    Sevilla, 41010
    Spain

    Site Not Available

  • ARENSIA Explor Med Res Clinic

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • ARENSIA Explor Med Res Clinic Research

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Novartis Investigative Site

    El Cajon, California 92020
    United States

    Active - Recruiting

  • TriWest Reserach Associates

    El Cajon, California 92020
    United States

    Site Not Available

  • TriWest Reserach Associates .

    El Cajon, California 92020
    United States

    Site Not Available

  • Biosolutions Clinical Research Center

    La Mesa, California 91942
    United States

    Site Not Available

  • Horizon Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Novartis Investigative Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Skylight Health Res Inc Color Spr

    Colorado Springs, Colorado 80917
    United States

    Site Not Available

  • Skylight Health Res Inc Color Spr Research

    Colorado Springs, Colorado 80917
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • IRIS Research and Development

    Plantation, Florida 33324
    United States

    Site Not Available

  • Integral Rheumatology and Immunology Specialists IRIS

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novartis Investigative Site

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Emory s Brain Health Center

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Ctr for Adv Research and Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Novartis Investigative Site

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Novartis Investigative Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Boston Univ School Of Medicine .

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Boston Univ School Of Medicine Biomed Research

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Metroplex Clinical Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novartis Investigative Site

    Dallas, Texas 75231
    United States

    Site Not Available

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