Osteoarthritis, Knee Trial (QUC398, Placebo) (2024)

Study Description

Brief Summary

The purpose of the study is to find out if the investigational treatment named QUC398 hasbeneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and welltolerated.

Detailed Description

This is a phase IIa study to establish the effect of QUC398 on pain and cartilagepreservation in participants with symptomatic knee OA

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

1. Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12 [Week 12]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee

Secondary Outcome Measures

1. Cartilage volume of the knee index region [Week 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in preservation of cartilage in the medial compartment of the target knee

2. Change from baseline in KOOS Pain subscale [Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time

3. Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS) [Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time

4. Change in Total KOOS [Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving clinical symptoms and improving function in the target knee over time

   See Also

   Clinical Trials Register

5. Change in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life [Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time

6. Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS [Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

   Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time

Eligibility Criteria

Criteria

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 kneeconfirmed by radiography in standing weight-bearing fixed flexion position andposterior-anterior view, at Screening 1

• Radiographic medial joint space width (mJSW) of 2 to 4 mm in men or 1.5 to 3.5 mm inwomen measured at the X=0.225 fixed point location within the medial tibio-femoralcompartment of the target knee at Screening 1

• Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) inthe target knee for the majority of days in the last 3 months prior to Screening 1, asper participant's judgement

• Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) inthe target knee at Screening 1 and 2

. Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target kneeduring the last 7 days prior to Screening 3, confirmed by: Completed pain diary for atleast 6 of the last 7 days prior to Screening 3, AND Diary reported Pain NRS ≥5 to ≤9for 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 Screening3

Exclusion Criteria:

• Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in thelast 3 months prior to Screening 1, as reported by the patient

• Symptomatic, patello-femoral pain in the target knee as per investigator's examinationat Screening 1

• Severe malalignment > 7.5º in the target knee (either varus or valgus), measured usingstandardized knee X-ray at Screening 1

• Patient unable or unwilling to undergo MRI or presenting absolute contraindications toMRI

• Previous exposure to any ADAMTS-5 drug, including QUC398.

• History or current diagnosis of ECG abnormalities

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

More Information

Publications