A Proof-of-concept Study to Examine QUC398 in Participants With Knee OA (2024)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

- mJSN 1-2 in the medial tibiofemoral compartment of the target knee, confirmed withXray by central reader 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05462990
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Denmark, France, Norway, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Additional Details

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

Arms & Interventions

Arms

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

Interventions

Drug: - QUC398

QUC398 150 mg/mL, solution for s.c. injection (1 mL)

Drug: - Placebo

Placebo 0 mg/mL, solution for s.c. injection (1 mL)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

CoastalOrthoandSportsMedofSWFlorida ., Bradenton, Florida

Status

Withdrawn

Address

CoastalOrthoandSportsMedofSWFlorida .

Bradenton, Florida, 34209

Site Contact

[emailprotected]

1-888-669-6682

Meridien Research, Maitland, Florida

Status

Withdrawn

Address

Meridien Research

Maitland, Florida, 32751

Site Contact

[emailprotected]

1-888-669-6682

Clinical Research of West FL Inc. ., Tampa, Florida

Status

Active, not recruiting

Address

Clinical Research of West FL Inc. .

Tampa, Florida, 33603

Site Contact

[emailprotected]

1-888-669-6682

Boston Univ School Of Medicine ., Boston, Massachusetts

Status

Recruiting

Address

Boston Univ School Of Medicine .

Boston, Massachusetts, 02118

Site Contact

Rutvi Patel

[emailprotected]

1-888-669-6682

West Clinical Research Private Clinic, Morehead City, North Carolina

Status

Active, not recruiting

International Sites

Novartis Investigative Site, St Leonards, New South Wales, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

St Leonards, New South Wales, 2065

Site Contact

[emailprotected]

1-888-669-6682

Novartis Investigative Site, Southport, Queensland, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

Southport, Queensland, 4222

Site Contact

[emailprotected]

1-888-669-6682

Novartis Investigative Site, Hobart, Tasmania, Australia

Status

Withdrawn

Address

Novartis Investigative Site

Hobart, Tasmania, 7000

Site Contact

[emailprotected]

1-888-669-6682

Novartis Investigative Site, Christchurch, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

Christchurch, , 8011

Site Contact

[emailprotected]

1-888-669-6682

Novartis Investigative Site, Herlev, Denmark

Status

Active, not recruiting

Address

Novartis Investigative Site

Herlev, , 2730

Site Contact

[emailprotected]

1-888-669-6682

Novartis Investigative Site, Vejle, Denmark

Status

Active, not recruiting

Address