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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QUC398
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring QUC398, Osteoarthritis of Knee, Osteoarthritis of the Knee, Knee joint, Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QUC398

Placebo

Arm Description

QUC398 150 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to complete the 300 mg

Placebo 0 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to ensure blinding

Outcomes

Primary Outcome Measures

Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at 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

Cartilage volume of the knee index region
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in preservation of cartilage in the medial compartment of the target knee
Change from baseline in KOOS Pain subscale
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS)
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Change in Total KOOS
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
Change in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time

Full Information

First Posted
July 14, 2022
Last Updated
September 27, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05462990
Brief Title
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA
Official Title
A Randomized, Two-arm, Placebo-controlled, Participant, Investigator and Sponsor-blinded, Proof-of-concept Study Investigating the Efficacy, Safety and Tolerability of QUC398 in Patients With Symptomatic Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2022 (Actual)
Primary Completion Date
November 4, 2024 (Anticipated)
Study Completion Date
October 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to find out if the investigational treatment named QUC398 has beneficial effects on osteoarthritis knee pain and knee cartilage, and if it is safe and well tolerated.
Detailed Description
This is a phase IIa study to establish the effect of QUC398 on pain and cartilage preservation in participants with symptomatic knee OA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
QUC398, Osteoarthritis of Knee, Osteoarthritis of the Knee, Knee joint, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
participant, investigator and sponsor-blinded
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QUC398
Arm Type
Experimental
Arm Description
QUC398 150 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to complete the 300 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 0 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to ensure blinding
Intervention Type
Drug
Intervention Name(s)
QUC398
Intervention Description
QUC398 150 mg/mL, solution for s.c. injection (1 mL)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 0 mg/mL, solution for s.c. injection (1 mL)
Primary Outcome Measure Information:
Title
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Cartilage volume of the knee index region
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in preservation of cartilage in the medial compartment of the target knee
Time Frame
Week 52
Title
Change from baseline in KOOS Pain subscale
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Time Frame
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS)
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Time Frame
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change in Total KOOS
Description
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
Time Frame
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Time Frame
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Title
Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS
Description
Efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee over time
Time Frame
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-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 in women measured at the X=0.225 fixed point location within the medial tibio-femoral compartment of the target knee 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Christchurch
ZIP/Postal Code
8011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nice
State/Province
Cedex1
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orleans
ZIP/Postal Code
45100
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
370
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
NO 0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08022
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28915
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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