Study Description
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.
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).
Interventions
DFV890
Placebo
Eligibility Criteria
Key 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.
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 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
Study Location
Novartis Investigative Site
Recruiting
San Miguel de Tucuman,Tucuman,T4000CBC,Argentina
Novartis Investigative Site
Recruiting
Tucuman,4000,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1181ACH,Argentina
Novartis Investigative Site
Recruiting
Uherske Hradiste,686 01,Czech Republic
Novartis Investigative Site
Recruiting
Brno,Czech Republic,66250,Czech Republic
Novartis Investigative Site
Recruiting
Novy Jicin,741 01,Czech Republic
Novartis Investigative Site
Recruiting
Leipzig,04107,Germany
Novartis Investigative Site
Recruiting
Dresden,01069,Germany
Novartis Investigative Site
Recruiting
Berlin,10787,Germany
Novartis Investigative Site
Recruiting
Hamburg,22143,Germany
Novartis Investigative Site
Recruiting
Wuerzburg,97074,Germany
Novartis Investigative Site
Recruiting
Hamburg,22415,Germany
Novartis Investigative Site
Recruiting
Miskolc,H-3529,Hungary
Novartis Investigative Site
Recruiting
Eger,3300,Hungary
Novartis Investigative Site
Recruiting
Budapest,1027,Hungary
Novartis Investigative Site
Recruiting
Cluj Napoca,Cluj,400006,Romania
Novartis Investigative Site
Recruiting
Bucharest,011658,Romania
Novartis Investigative Site
Recruiting
Nove Mesto nad Vahom,91501,Slovakia
Novartis Investigative Site
Recruiting
Piestany,92101,Slovakia
Novartis Investigative Site
Recruiting
Sevilla,41010,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08003,Spain
Novartis Investigative Site
Recruiting
Sabadell,Barcelona,08208,Spain
Novartis Investigative Site
Recruiting
La Coruna,Galicia,15006,Spain
Northwestern University
Recruiting
Chicago,Witte Graeme (312-503-2300) email: [email protected] -- Thomas J. Schnitzer,60611 - Illinois,United States
Boston Univ School Of Medicine .
Recruiting
Boston,Rutvi Patel email: [email protected] -- Tuhina Neogi,02118 - Massachusetts,United States
Ctr for Adv Research and Education
Recruiting
Gainesville,Judy Outwater (770-534-5154) email: [email protected] -- Angela Ritter,30501 - Georgia,United States
Panax Clinical Research
Recruiting
Miami Lakes,Lina Giraldo (305-698-4500) email: [email protected] -- Robert G Perry,33014 - Florida,United States
Integral Rheumatology and Immunology Specialists IRIS
Recruiting
Plantation,Ana Santana (954-476-2338) email: [email protected] -- Guillermo Valenzuela,33324 - Florida,United States
TriWest Reserach Associates .
Recruiting
El Cajon,Patricia Corona (619-334-4735) email: [email protected] -- Arthur Mabaquiao,92020 - California,United States
Worldwide Contacts
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