Phase
Condition
Osteoarthritis
Treatment
Placebo
DFV890
Clinical Study ID
Ages 50-80 All Genders
Study Summary
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
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1181ACH
ArgentinaSite Not Available
Novartis Investigative Site
San Miguel de Tucuman, Tucuman T4000CBC
ArgentinaSite Not Available
Novartis Investigative Site
Tucuman, 4000
ArgentinaSite Not Available
Novartis Investigative Site
Gent, 9000
BelgiumSite Not Available
Novartis Investigative Site
Leuven, 3000
BelgiumSite Not Available
Novartis Investigative Site
Brno, Czech Republic 66250
CzechiaSite Not Available
Novartis Investigative Site
Novy Jicin, 741 01
CzechiaSite Not Available
Novartis Investigative Site
Praha 2, 128 50
CzechiaSite Not Available
Novartis Investigative Site
Praha 5, 150 06
CzechiaSite Not Available
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaSite Not Available
Novartis Investigative Site
Bad Doberan, 18209
GermanySite Not Available
Novartis Investigative Site
Berlin, 10787
GermanySite Not Available
Novartis Investigative Site
Dresden, 01069
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22415
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04107
GermanySite Not Available
Novartis Investigative Site
Wuerzburg, 97074
GermanySite Not Available
Novartis Investigative Site
Kecskemet, Bacs Kiskun 6044
HungarySite Not Available
Novartis Investigative Site
Tata, Komarom Esztergom 2890
HungarySite Not Available
Novartis Investigative Site
Budapest, 1027
HungarySite Not Available
Novartis Investigative Site
Eger, 3300
HungarySite Not Available
Novartis Investigative Site
Gyor, H-9024
HungarySite Not Available
Novartis Investigative Site
Miskolc, H-3526
HungarySite Not Available
Novartis Investigative Site
Szeged, 6720
HungarySite Not Available
Novartis Investigative Site
Veszprem, 8200
HungarySite Not Available
Novartis Investigative Site
Zalaegerszeg, 8900
HungarySite Not Available
Novartis Investigative Site
Cluj Napoca, Cluj 400006
RomaniaSite Not Available
Novartis Investigative Site
Bucharest, 011658
RomaniaSite Not Available
Novartis Investigative Site
Martin, 036 01
SlovakiaSite Not Available
Novartis Investigative Site
Nove Mesto nad Vahom, 91501
SlovakiaSite Not Available
Novartis Investigative Site
Piestany, 92101
SlovakiaSite Not Available
Novartis Investigative Site
Rimavska Sobota, 979 01
SlovakiaSite Not Available
Novartis Investigative Site
Santiago De Compostela, A Coruna 15705
SpainSite Not Available
Novartis Investigative Site
Sabadell, Barcelona 08208
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainSite Not Available
Novartis Investigative Site
La Coruna, Galicia 15006
SpainSite Not Available
Novartis Investigative Site
Sevilla, 41010
SpainSite Not Available
ARENSIA Explor Med Res Clinic
Phoenix, Arizona 85015
United StatesSite Not Available
ARENSIA Explor Med Res Clinic Research
Phoenix, Arizona 85015
United StatesSite Not Available
Novartis Investigative Site
El Cajon, California 92020
United StatesActive - Recruiting
TriWest Reserach Associates
El Cajon, California 92020
United StatesSite Not Available
TriWest Reserach Associates .
El Cajon, California 92020
United StatesSite Not Available
Biosolutions Clinical Research Center
La Mesa, California 91942
United StatesSite Not Available
Horizon Clinical Research
La Mesa, California 91942
United StatesSite Not Available
Novartis Investigative Site
La Mesa, California 91942
United StatesSite Not Available
Skylight Health Res Inc Color Spr
Colorado Springs, Colorado 80917
United StatesSite Not Available
Skylight Health Res Inc Color Spr Research
Colorado Springs, Colorado 80917
United StatesSite Not Available
Novartis Investigative Site
Miami Lakes, Florida 33014
United StatesActive - Recruiting
Panax Clinical Research
Miami Lakes, Florida 33014
United StatesSite Not Available
IRIS Research and Development
Plantation, Florida 33324
United StatesSite Not Available
Integral Rheumatology and Immunology Specialists IRIS
Plantation, Florida 33324
United StatesSite Not Available
Novartis Investigative Site
Plantation, Florida 33324
United StatesActive - Recruiting
Conquest Research
Winter Park, Florida 32789
United StatesSite Not Available
Emory s Brain Health Center
Atlanta, Georgia 30329
United StatesSite Not Available
Novartis Investigative Site
Atlanta, Georgia 30329
United StatesSite Not Available
Ctr for Adv Research and Education
Gainesville, Georgia 30501
United StatesSite Not Available
Novartis Investigative Site
Gainesville, Georgia 30501
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Novartis Investigative Site
Chicago, Illinois 60611
United StatesActive - Recruiting
Boston Univ School Of Medicine .
Boston, Massachusetts 02118
United StatesActive - Recruiting
Boston Univ School Of Medicine Biomed Research
Boston, Massachusetts 02118
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02118
United StatesActive - Recruiting
Metroplex Clinical Research
Dallas, Texas 75231
United StatesSite Not Available
Novartis Investigative Site
Dallas, Texas 75231
United StatesSite Not Available
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