A proof of concept study to examine QUC398 in participants with knee OA.

Phase 1

• Conditions: Knee osteoarthritis; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-002795-39-DK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 123

Inclusion 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.

Additional protocol specified criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

•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.

Additional protocol specified criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy of QUC398 vs placebo in relieving OA pain in the target knee;Secondary Objective: •To assess the efficacy of QUC398 vs placebo in preservation of cartilage in the medial compartment of the target knee<br>•To assess the efficacy of QUC398 vs placebo in relieving OA pain in the target knee over time<br>•To assess the efficacy of QUC398 vs placebo in relieving clinical symptoms and improving function in the target knee over time<br>•To assess the safety and tolerability of QUC398 vs placebo.;Primary end point(s): Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12<br>;Timepoint(s) of evaluation of this end point: Week 12