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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05462990
Registration number
NCT05462990
Ethics application status
Date submitted
14/07/2022
Date registered
18/07/2022
Date last updated
13/06/2024
Titles & IDs
Public title
A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA
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Scientific 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
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Secondary ID [1]00
2021-002795-39
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Secondary ID [2]00
CQUC398A12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee00
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Condition category
Condition code
Musculoskeletal0000
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - QUC398 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 Placebo comparator: Placebo - Placebo 0 mg/mL, solution for s.c. injection (1 mL). 2 injections will be applied per dose to ensure blinding Treatment: Drugs: QUC398 Treatment: Drugs: Placebo
Treatment: Drugs - Placebo
QUC398 150 mg/mL, solution for s.c. injection (1 mL)
Placebo 0 mg/mL, solution for s.c. injection (1 mL)
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Intervention code [1]00
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]00
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale at Week 12
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Timepoint [1]00
Week 12
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Secondary outcome [1]00
Cartilage volume of the knee index region
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Timepoint [1]00
Week 52
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Secondary outcome [2]00
Change from baseline in KOOS Pain subscale
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Timepoint [2]00
Weeks 1 (Day 5), 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Secondary outcome [3]00
Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS)
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Timepoint [3]00
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Secondary outcome [4]00
Change in Total KOOS
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Timepoint [4]00
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Secondary outcome [5]00
Change in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life
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Timepoint [5]00
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Secondary outcome [6]00
Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS
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Timepoint [6]00
Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Eligibility
Key inclusion criteria
* Weight = 50 kg and body mass index 18 -35 kg/m2 at Screening 1 . 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
* 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
* KOOS pain subscale = 60 in the target knee at Screening 1, Screening 2, and Screening 3
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Minimum age
40Years
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Maximum age
80Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 Other protocol-defined inclusion/exclusion criteria may apply
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)
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Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
101
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]00
Novartis Investigative Site - St Leonards
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Recruitment hospital [2]00
Novartis Investigative Site - Southport
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Recruitment hospital [3]00
Novartis Investigative Site - Christchurch
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Recruitment postcode(s) [1]00
2065 - St Leonards
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Recruitment postcode(s) [2]00
4222 - Southport
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Recruitment postcode(s) [3]00
8011 - Christchurch
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Recruitment outside Australia
Country [1]00
United States of America
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State/province [1]00
Florida
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Country [2]00
United States of America
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State/province [2]00
Massachusetts
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Country [3]00
United States of America
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State/province [3]00
North Carolina
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Country [4]00
Denmark
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State/province [4]00
Herlev
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Country [5]00
Denmark
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State/province [5]00
Vejle
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Country [6]00
France
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State/province [6]00
Cedex1
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Country [7]00
France
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State/province [7]00
Orleans
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Country [8]00
Spain
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State/province [8]00
Barcelona
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Country [9]00
Spain
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State/province [9]00
Galicia
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Country [10]00
Spain
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State/province [10]00
Madrid
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Country [11]00
Spain
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State/province [11]00
Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05462990
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name00
Novartis Pharmaceuticals
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Address00
Novartis Pharmaceuticals
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Country00
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Phone00
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Fax00
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Email00
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Contact person for public queries
Name00
Novartis Pharmaceuticals
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Address00
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Country00
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Phone00
1-888-669-6682
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Fax00
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Email00
novartis.email@novartis.com
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Contact person for scientific queries
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
