BridgeMD
A proof-of-concept study to examine QUC398 in participants with knee osteoarthritis
EU CTIS ID: 2023-509274-28-00
What this study is testing
To assess the efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Weight ≥ 50 kg and a body mass index (BMI) between 18 -35 kg/m2, at Screening 1
- Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
- Radiographic medial joint space narrowing (mJSN) 1-2 within the medial tibio-femoral compartment of the target knee, confirmed by Xray at Screening 1
- Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant’s judgement
- Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and 2.
- Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by: • Completed pain diary for at least 6 of the last 7 days prior to Screening 3, AND • Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
You likely can't join if
- Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient.
- Symptomatic, patello-femoral pain in the target knee as per investigator’s examination at Screening 1.
- Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1.
- Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI.
- Previous exposure to any ADAMTS-5 drug, including QUC398
- History or current diagnosis of relevant cardiovascular diseases and ECG abnormalities.
See the full eligibility criteria
- Weight ≥ 50 kg and a body mass index (BMI) between 18 -35 kg/m2, at Screening 1
- Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
- Radiographic medial joint space narrowing (mJSN) 1-2 within the medial tibio-femoral compartment of the target knee, confirmed by Xray at Screening 1
- Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant’s judgement
- Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and 2.
- Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by: • Completed pain diary for at least 6 of the last 7 days prior to Screening 3, AND • Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
- KOOS pain subscale ≤ 60 in the target knee at Screening 1, Screening 2, and Screening 3
- Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient.
- Symptomatic, patello-femoral pain in the target knee as per investigator’s examination at Screening 1.
- Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1.
- Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI.
- Previous exposure to any ADAMTS-5 drug, including QUC398
- History or current diagnosis of relevant cardiovascular diseases and ECG abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.