New drug shows promise for easing knee arthritis pain
NCT ID NCT04886258
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called DFV890 in 115 adults aged 50-80 with painful knee osteoarthritis. Participants received either the drug or a placebo to see if it reduced pain and inflammation. The goal was to find a new way to ease symptoms and improve daily function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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115 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Additional protocol-defined inclusion / exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ARENSIA Explor Med Res Clinic
Phoenix, Arizona, 85015, United States
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Conquest Research
Winter Park, Florida, 32789, United States
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Ctr for Adv Research and Education
Gainesville, Georgia, 30501, United States
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IRIS Research and Development
Plantation, Florida, 33324, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Novartis Investigative Site
CABA, Buenos Aires, C1181ACH, Argentina
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Novartis Investigative Site
San Miguel, Tucumán Province, T4000CBC, Argentina
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Novartis Investigative Site
San Miguel de Tucumán, 4000, Argentina
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Novartis Investigative Site
Brno, Czech Republic, 66250, Czechia
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Novartis Investigative Site
Nový Jičín, 741 01, Czechia
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Novartis Investigative Site
Prague, 150 06, Czechia
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Novartis Investigative Site
Uherské Hradiště, 686 01, Czechia
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Novartis Investigative Site
Bad Doberan, 18209, Germany
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Novartis Investigative Site
Berlin, 10787, Germany
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Novartis Investigative Site
Hamburg, 22143, Germany
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Novartis Investigative Site
Hamburg, 22415, Germany
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Novartis Investigative Site
Leipzig, 04107, Germany
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Novartis Investigative Site
Kecskemét, Bács-Kiskun county, 6044, Hungary
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Novartis Investigative Site
Budapest, 1027, Hungary
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Novartis Investigative Site
Miskolc, 3526, Hungary
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Novartis Investigative Site
Veszprém, 8200, Hungary
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Novartis Investigative Site
Cluj-Napoca, Cluj, 400006, Romania
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Novartis Investigative Site
Bucharest, 011658, Romania
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Novartis Investigative Site
Nové Mesto nad Váhom, 915 01, Slovakia
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Novartis Investigative Site
Piešťany, 921 01, Slovakia
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Novartis Investigative Site
Sabadell, Barcelona, 08208, Spain
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Novartis Investigative Site
Barcelona, Catalonia, 08003, Spain
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Novartis Investigative Site
A Coruña, 15006, Spain
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Novartis Investigative Site
Seville, 41010, Spain
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Skylight Health Res Inc Color Spr
Colorado Springs, Colorado, 80917, United States
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TriWest Reserach Associates
El Cajon, California, 92020, United States
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