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
Worldwide Contacts
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