A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA

Purpose

The purpose of the study was to find out if the investigational treatment named QUC398 had beneficial effects on osteoarthritis (OA) knee pain and knee cartilage, and if it was safe and tolerated.

Condition

  • Osteoarthritis, Knee

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Weight ≥ 50 kg and body mass index 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 - mJSN 1-2 in the medial tibiofemoral compartment of the target knee, confirmed with Xray by central reader 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

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 ECG abnormalities Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
participant, investigator and sponsor-blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
QUC398 300 mg 		QUC398 was administered subcutaneous every 4 weeks during 48 weeks.
  • Drug: QUC398
    QUC398 150 mg/mL, solution for subcutaneous (s.c) injection (1 mL). 2 injections were administered to complete 300 mg.
Placebo Comparator
Placebo 		Placebo was administered subcutaneous every 4 weeks during 48 weeks.
  • Drug: Placebo
    Matching Placebo solution for s.c. injection (1 mL). 2 injections were administered per dose to ensure blinding.

More Details

Status
Terminated
Sponsor
Novartis Pharmaceuticals

Study Contact

Detailed Description

This was a non-confirmatory study using a randomized, placebo-controlled, parallel-group, participant, investigator and sponsor-blinded design to investigate efficacy, safety and tolerability of subcutaneous injections of QUC398 300 mg vs placebo every 4 weeks (q4w) in participants with symptomatic knee OA.