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

ClinicalTrials.gov Identifier: NCT04886258

Novartis Reference Number: CDFV890B12201

Last Update: Nov 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

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.

Condition 
Symptomatic Knee Osteoarthritis
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 20, 2021
Completion date 
Apr 05, 2024
Gender 
All
Age(s)
50 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
DFV890
DFV890
Drug
Placebo
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 as either moderate (score 9-12) or severe (score >=13) based 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.e. 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 repair within 2 weeks prior to Day 1; systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or selective COX-2 inhibitors 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.
Participants with the CYP2C9 *3/*3 genotype defined as homozygous carriers of the CYP2C9*3 allele.
Severe malalignment greater than 7.5 degrees in the target knee (either varus or valgus), measured using x-ray at Screening

Study Locations

United States
Novartis Investigative Site
Recruiting
El Cajon, 92020
California
United States
Novartis Investigative Site
Recruiting
La Mesa, 91942
California
United States
Novartis Investigative Site
Recruiting
Miami Lakes, 33014
Florida
United States
Novartis Investigative Site
Recruiting
Plantation, 33324
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30329
Georgia
United States
Novartis Investigative Site
Recruiting
Gainesville, 30501
Georgia
United States
Novartis Investigative Site
Recruiting
Chicago, 60611
Illinois
United States
Novartis Investigative Site
Recruiting
Boston, 02118
Massachusetts
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
San Miguel de Tucuman,
Tucuman
Argentina
Novartis Investigative Site
Recruiting
Tucuman, 4000
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Czech Republic
Novartis Investigative Site
Recruiting
Praha 2, 128 50
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Berlin, 10787
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01069
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22143
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22415
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04107
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97074
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1027
-
Hungary
Novartis Investigative Site
Recruiting
Veszprem, 8200
-
Hungary
Slovakia
Novartis Investigative Site
Recruiting
Nove Mesto nad Vahom, 91501
-
Slovakia
Novartis Investigative Site
Recruiting
Piestany, 92101
-
Slovakia
Novartis Investigative Site
Recruiting
Rimavska Sobota, 979 01
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Sabadell, 08208
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41010
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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