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Trial record 1 of 1 for:    QUC398 | Osteo Arthritis Knee | Florida, United States
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A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05462990
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : January 23, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: QUC398 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: participant, investigator and sponsor-blinded
Primary Purpose: Treatment
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
Actual Study Start Date : November 9, 2022
Estimated Primary Completion Date : November 4, 2024
Estimated Study Completion Date : October 6, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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

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




Primary Outcome Measures :
  1. Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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

  5. Change in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05462990


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Bradenton, Florida, United States, 34209
Novartis Investigative Site Recruiting
Maitland, Florida, United States, 32751
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33603
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02118
United States, North Carolina
Novartis Investigative Site Recruiting
Morehead City, North Carolina, United States, 28557
Australia, New South Wales
Novartis Investigative Site Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Novartis Investigative Site Recruiting
Southport, Queensland, Australia, 4222
Australia, Tasmania
Novartis Investigative Site Recruiting
Hobart, Tasmania, Australia, 7000
Australia
Novartis Investigative Site Recruiting
Christchurch, Australia, 8011
Denmark
Novartis Investigative Site Recruiting
Herlev, Denmark, 2730
Novartis Investigative Site Recruiting
Vejle, Denmark, 7100
France
Novartis Investigative Site Recruiting
Nice, Cedex1, France, 06001
Novartis Investigative Site Recruiting
Lille, Hauts De France, France, 59160
Novartis Investigative Site Recruiting
Lyon, France, 69437
Novartis Investigative Site Recruiting
Orleans, France, 45100
Novartis Investigative Site Recruiting
Paris, France, 75012
Norway
Novartis Investigative Site Recruiting
Oslo, Norway, 370
Novartis Investigative Site Withdrawn
Oslo, Norway, NO 0450
Spain
Novartis Investigative Site Recruiting
Sabadell, Barcelona, Spain, 08208
Novartis Investigative Site Recruiting
Barcelona, Cataluna, Spain, 08022
Novartis Investigative Site Recruiting
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site Recruiting
Leganes, Madrid, Spain, 28915
Novartis Investigative Site Recruiting
Sevilla, Spain, 41010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05462990    
Other Study ID Numbers: CQUC398A12201
2021-002795-39 ( EudraCT Number )
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: January 23, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QUC398
Osteoarthritis of Knee
Osteoarthritis of the Knee
Knee joint
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases