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New injection aims to ease knee arthritis pain and protect cartilage

NCT ID NCT05462990

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an investigational drug called QUC398 in 101 people with painful knee osteoarthritis. Participants received either QUC398 injections or a placebo. The goal was to see if the drug could reduce knee pain and improve cartilage health. The trial was terminated early, so final conclusions are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QUC398 (injectable drug)
What this could lead to
If successful, QUC398 could offer a new option to reduce knee pain and potentially slow cartilage loss in osteoarthritis.
What could go wrong
This was an early proof-of-concept study that was terminated, so results are limited. The drug may not prove effective or safe in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

101 people

The number who actually took part.

Started

Nov 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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 * 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

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee

Contacts and locations

Locations

  • Boston Univ School of Medicine

    Boston, Massachusetts, 02118, United States

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33603, United States

  • Novartis Investigative Site

    Southport, Queensland, 4222, Australia

  • Novartis Investigative Site

    Christchurch, 8011, Australia

  • Novartis Investigative Site

    St Leonards, 2065, Australia

  • Novartis Investigative Site

    Herlev, 2730, Denmark

  • Novartis Investigative Site

    Vejle, 7100, Denmark

  • Novartis Investigative Site

    Nice, 06001, France

  • Novartis Investigative Site

    Orléans, 45100, France

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Leganés, Madrid, 28915, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Seville, 41010, Spain

  • West Clinical Research

    Morehead City, North Carolina, 28557, United States

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