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New hope for Still's disease: experimental drug enters Mid-Stage trial

NCT ID NCT07203001

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests a new medicine called MAS825 for people with Still's disease, a rare inflammatory condition causing fever, rash, and joint pain. About 20 children and adults with active disease will receive the drug to see if it safely controls symptoms. The goal is to improve daily life by reducing inflammation and flares.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2028

An estimate. End dates often move.

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

1 year and older

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: * Age ≥ 1 with a diagnosis of Still's Disease * Active diseases defined as: * CRP or ferritin levels greater than ULN, and any of: * Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or * Rash attributed to Still's Disease activity or * Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or * Serositis or * Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator * Intolerance or inadequate response to available biologic therapy Exclusion Criteria: * Patients out of weight range * Ongoing or previous treatment with immunomodulatory drugs * A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study * Glucocorticoid dose exceeding a set limit * Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy * Still's disease patients with evidence of macrophage activation syndrome are permitted in the study * Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study * History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and/or symptoms and signs of clinically significant active bacterial, fungal or viral infections * Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose * History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients * Pregnant or breastfeeding women * Women of child-bearing potential who do not agree to comply with required contraceptive use Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Childrens Hospital

    ACTIVE_NOT_RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Legacy Emanuel Research Hosp Portland

    RECRUITING

    Portland, Oregon, 97232, United States

  • Novartis Investigative Site

    WITHDRAWN

    Montreal, Quebec, H3T 1C5, Canada

  • Novartis Investigative Site

    WITHDRAWN

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Bron, 69677, France

  • Novartis Investigative Site

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    RECRUITING

    Lille, 59037, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75015, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75970, France

  • Novartis Investigative Site

    RECRUITING

    Sankt Augustin, North Rhine-Westphalia, 53757, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    RECRUITING

    Florence, FI, 50139, Italy

  • Novartis Investigative Site

    RECRUITING

    Genova, GE, 16147, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Esplugues, Barcelona, 08950, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28046, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    RECRUITING

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States

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Other studies related to the condition(s) this trial covers.