Symptomatic Knee OsteoarthritisPhase 2NCT04886258
Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis
A Phase 2 study testing DFV890 in people with Symptomatic Knee Osteoarthritis, run by Novartis Pharmaceuticals at 31 sites in 8 countries.
Trial summary
This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Symptomatic Knee Osteoarthritis
- What is being tested?
- DFV890
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 20 Sep 2021to 23 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
United States7 sites
Northwestern University
Chicago, Illinois, 60611
Skylight Health Res Inc Color Spr
Colorado Springs, Colorado, 80917
TriWest Reserach Associates
El Cajon, California, 92020
Ctr for Adv Research and Education
Gainesville, Georgia, 30501
ARENSIA Explor Med Res Clinic
Phoenix, Arizona, 85015
IRIS Research and Development
Plantation, Florida, 33324
Conquest Research
Winter Park, Florida, 32789
Germany5 sites
Novartis Investigative Site
Bad Doberan, 18209
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hamburg, 22415
Novartis Investigative Site
Leipzig, 04107
Czechia4 sites
Novartis Investigative Site
Brno, Czech Republic, 66250
Novartis Investigative Site
Nový Jičín, 741 01
Novartis Investigative Site
Prague, 150 06
Novartis Investigative Site
Uherské Hradiště, 686 01
Hungary4 sites
Novartis Investigative Site
Budapest, 1027
Novartis Investigative Site
Kecskemét, Bács-Kiskun county, 6044
Novartis Investigative Site
Miskolc, 3526
Novartis Investigative Site
Veszprém, 8200
Spain4 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Seville, 41010
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1181ACH
Novartis Investigative Site
San Miguel, Tucumán Province, T4000CBC
Novartis Investigative Site
San Miguel de Tucumán, 4000
Romania2 sites
Novartis Investigative Site
Bucharest, 011658
Novartis Investigative Site
Cluj-Napoca, Cluj, 400006
Slovakia2 sites
Novartis Investigative Site
Nové Mesto nad Váhom, 915 01
Novartis Investigative Site
Piešťany, 921 01
About this study
Official title: 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
This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.
Read the detailed description
The purpose of the Phase 2a proof of concept study was 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). The study had a screening period up to 45 days, a treatment period of 12 weeks and a 4-week follow-up period. At most, the study duration was 21 weeks.
- Conditions
- Symptomatic Knee Osteoarthritis
- Being tested
- DFV890, Placebo
- Keywords
- Osteoarthritis, Knee osteoarthritis, DFV890, Adult, NLRP3 inhibitor, Inflammasome inhibition
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFV890Drug
DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.
PlaceboDrug
Matching Placebo was administered orally twice per day during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DFV890 | Experimental | DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks. Receives: Drug: DFV890 |
| Placebo | Placebo comparator | Matching Placebo was administered orally twice per day during 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for each subscale. Change from baseline in KOOS pain score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 12
Secondary outcomes (13)
Change From Baseline in Synovitis Activity Level Measured From Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI)
Magnetic resonance images (MRI) were obtained from the target knee with dynamic contrast enhancement (DCE) to visualize and quantify changes in k-trans as a marker of the activity of synovial inflammation. In dynamic contrast-enhanced MRI, ktrans is a parameter that reflects how quickly contrast agent moves from blood vessels into the surrounding tissue, capturing both blood flow and vascular permeability. In synovitis, inflamed synovial tissue shows increased perfusion and leaky microvasculature, so higher k-trans values are interpreted as indicating more active synovial inflammation. Change from baseline in synovitis activity level measured from ktrans was analyzed to compare treatment groups. The model included treatment as fixed effect and baseline as continuous covariate. Ktrans is a marker of synovial inflammation in relation to vascularity permeability.
Measured: Baseline, Week 12
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) Level
HsCRP is a protein produced by the liver in response to inflammation in the body, such as from an infection, injury, or chronic inflammatory conditions. HsCRP was used to assess the effect of DFV890 compared to placebo on systemic inflammatory status.
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Absolute Neutrophil Counts (ANC)
ANC measures the number of neutrophils, a type of white blood cell crucial for fighting infection, in a blood sample. ANC was used to judge target engagement of DFV890.
Measured: Baseline, Weeks 2, 4, 8 and 12
Maximum Plasma Concentration (Cmax) of DFV890
Cmax is defined as the maximum (peak) observed concentration following a dose. DFV890 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8). DFV890 was determined by a validated LC-MS/MS method; the lower limit of quantification (LLOQ) is 1 ng/mL.
Measured: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of DFV890
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast). DFV890 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8). DFV890 was determined by a validated LC-MS/MS method; the lower limit of quantification (LLOQ) is 1 ng/mL.
Measured: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Area Under Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of DFV890
AUC(0-12h) is the area under the plasma concentration-time curve from time zero to 12 hours. To calculate AUC0-12h (corresponding to AUCtau, or AUC within a dosing interval), the concentration at 0 hours was used also as a 12 hours time point or, if not feasible, AUC0-12h was extrapolated. DFV890 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8). DFV890 was determined by a validated LC-MS/MS method; the lower limit of quantification (LLOQ) is 1 ng/mL.
Measured: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Pre-dose Trough Concentration (Ctrough) of DFV890
DFV890 plasma concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8). DFV890 was determined by a validated LC-MS/MS method; the anticipated lower limit of quantification (LLOQ) is 1 ng/mL.
Measured: Week 2 and Week 12: pre-dose
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is other symptoms (eg., stiffness, swelling, clicking) consisting of 7 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change from baseline in other symptoms score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the Function in Daily Living consisting of 17 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no impact on function in daily living and 0 indicating extreme impact on function in daily living) is calculated for each subscale. Change from baseline in KOOS daily living function score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the function in sport and recreation consisting of 5 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no impact on sport and recreation and 0 indicating extreme impact on sport and recreation) is calculated for each subscale. Change from baseline in function in sport and recreation score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee-related Quality of Life (QOL) Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the knee-related quality of life consisting of 4 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no impact on knee-related quality of life and 0 indicating extreme impact on knee-related quality of life) is calculated for each subscale. Change from baseline in knee related quality of life score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for each subscale. Change from baseline in KOOS pain score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Week 2, 4, 8
Change From Baseline in Numeric Rating Scale (NRS) for Pain
The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. NRS pain score ranges from 0-10 and for analyses were transformed to a 0-100 scale to be consistent with KOOS pain scores. A negative change from baseline implied improvement in pain. The NRS Pain instrument had a recall period of 24 hours and the participants were asked to rate the pain intensity at its worst. Change from baseline in NRS pain score was analyzed using a MMRM including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
Measured: Baseline, Weeks 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start20 Sep 2021
- Primary completion14 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886258
- Sponsor's protocol ID
- CDFV890B12201
- Other IDs
- 2020-006104-17
- Status last verified
- Mar 2026
- First submitted
- 10 May 2021
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT04886258
- Acronym / sponsor ID
- CDFV890B12201
- Conditions
- Symptomatic Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee osteoarthritis, DFV890, Adult, NLRP3 inhibitor, Inflammasome inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.
Detailed description
The purpose of the Phase 2a proof of concept study was 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). The study had a screening period up to 45 days, a treatment period of 12 weeks and a 4-week follow-up period. At most, the study duration was 21 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFV890 | Experimental | Drug: DFV890DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo was administered orally twice per day during 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFV890DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks. | Drug | DFV890 |
| PlaceboMatching Placebo was administered orally twice per day during 12 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Time frame: Baseline, Week 12
The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales. One of those is the pain frequency/severity during functional activities consisting of 9 questions with a recall of 7 days. Each question has 5 standardized answer options with a score from 0 to 4. A normalized score (100 indicating no pain and 0 indicating extreme pain) is calculated for each subscale. Change from baseline in KOOS pain score was analyzed using a mixed effects model for repeated measures (MMRM) including all time-points to compare treatment groups. The model includes baseline, treatment, timepoint, baseline-by-timepoints interaction and treatment-by-timepoints interaction as fixed effects. Missing data is assumed to be Missing at Random (MAR).
13 secondary outcomes
Change From Baseline in Synovitis Activity Level Measured From Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI)
Time frame: Baseline, Week 12
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) Level
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Absolute Neutrophil Counts (ANC)
Time frame: Baseline, Weeks 2, 4, 8 and 12
Maximum Plasma Concentration (Cmax) of DFV890
Time frame: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of DFV890
Time frame: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Area Under Plasma Concentration-time Curve From Time Zero to 12 Hours (AUC0-12h) of DFV890
Time frame: Week 2 and Week 12: pre-dose, 1h, 3h, 5h, 8h
Pre-dose Trough Concentration (Ctrough) of DFV890
Time frame: Week 2 and Week 12: pre-dose
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Other Symptoms Subscale
Time frame: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Daily Living Subscale
Time frame: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation Subscale
Time frame: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee-related Quality of Life (QOL) Subscale
Time frame: Baseline, Week 2, 4, 8 and 12
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Time frame: Baseline, Week 2, 4, 8
Change From Baseline in Numeric Rating Scale (NRS) for Pain
Time frame: Baseline, Weeks 2, 4, 8 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFV890 in people with Symptomatic Knee Osteoarthritis, run by Novartis Pharmaceuticals at 31 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Germany, Czechia, Hungary, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.