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

CompletadoFase 2ClinicalTrials.gov

ID: NCT04886258Tipo: INTERVENTIONALInicio: 20 de sept de 2021Fin estimado: 23 de dic de 2024

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Resumen

This was a double-blinded, two-arm, phase 2a study to assess efficacy, safety and tolerability of DFV890 in participants with symptomatic knee osteoarthritis.

Descripción detallada

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.

Elegibilidad

Edad mínima: 50 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

DFV890

DFV890 was administered orally twice per day, 10 mg during 2 weeks and 25 mg during the next 10 weeks.

drug

Placebo

Matching Placebo was administered orally twice per day during 12 weeks.

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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