New hope for Still's disease: experimental drug enters Mid-Stage trial
NCT ID NCT07203001
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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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
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
19 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cincinnati Childrens Hospital
ACTIVE_NOT_RECRUITINGCincinnati, Ohio, 45229, United States
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Legacy Emanuel Research Hosp Portland
RECRUITINGPortland, Oregon, 97232, United States
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Novartis Investigative Site
WITHDRAWNMontreal, Quebec, H3T 1C5, Canada
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Novartis Investigative Site
WITHDRAWNMontreal, Quebec, H4A 3J1, Canada
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Novartis Investigative Site
RECRUITINGBordeaux, 33076, France
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Novartis Investigative Site
RECRUITINGBron, 69677, France
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Novartis Investigative Site
RECRUITINGLe Kremlin-Bicêtre, 94275, France
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Novartis Investigative Site
RECRUITINGLille, 59037, France
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Novartis Investigative Site
RECRUITINGParis, 75015, France
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Novartis Investigative Site
RECRUITINGParis, 75970, France
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Novartis Investigative Site
RECRUITINGSankt Augustin, North Rhine-Westphalia, 53757, Germany
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Novartis Investigative Site
RECRUITINGHeidelberg, 69120, Germany
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Novartis Investigative Site
RECRUITINGMünster, 48149, Germany
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Novartis Investigative Site
RECRUITINGFlorence, FI, 50139, Italy
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Novartis Investigative Site
RECRUITINGGenova, GE, 16147, Italy
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Novartis Investigative Site
RECRUITINGRoma, RM, 00165, Italy
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Novartis Investigative Site
ACTIVE_NOT_RECRUITINGUtrecht, 3584 CX, Netherlands
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Novartis Investigative Site
RECRUITINGEsplugues, Barcelona, 08950, Spain
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Novartis Investigative Site
RECRUITINGMadrid, 28046, Spain
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Novartis Investigative Site
RECRUITINGValencia, 46026, Spain
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Novartis Investigative Site
RECRUITINGIstanbul, Fatih, 34098, Turkey (Türkiye)
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Novartis Investigative Site
RECRUITINGAnkara, Sihhiye-Altindag, 06230, Turkey (Türkiye)
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University of Utah
RECRUITINGSalt Lake City, Utah, 84113, United States
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