ClinicalTrials.gov record NCT07203001

A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

An Open-label Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age1 year old and older
SexAll
LocationCanada, France, Germany, Italy, Netherlands, Spain, Turkey, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label, single-arm Phase II study evaluates MAS825 (arumakimig) in pediatric and adult participants with Still's disease. It focuses on people with inadequate response to IL-1 and/or IL-6 or other available therapies; participants with associated lung disease or macrophage activation syndrome may also be included. The study has screening plus two treatment periods and lasts about 16 months. Primary and secondary outcomes include clinical response at Day 85 and other measures up to 15 months.

What it is studying. The study is testing the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease.

What the researchers hope to learn. To measure clinical response to MAS825 using established rheumatology response criteria at Day 85; to assess changes in disease biomarkers; to evaluate effects on macrophage activation syndrome features; to assess whether MAS825 affects glucocorticoid dose requirements; to measure changes in patient/parent-reported physical function; and to count participants with clinically inactive disease while on low corticosteroid dose by 15 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • MAS825

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included. This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive the experimental drug MAS825 in an open-label, single-arm trial and be followed for about 16 months across three periods (screening, Treatment Period 1, Treatment Period 2). Visits will include regular clinic assessments, blood tests for safety and biomarkers, physician evaluations of disease activity, and questionnaires about physical function/quality of life; glucocorticoid dose will be recorded. Participants must avoid live vaccines for defined time windows before and for several months after treatment, and the study team will monitor for infections, hypersensitivity, and other safety concerns; women of child-bearing potential must follow contraception requirements.

How the study is structured. An interventional, open-label, single-group (no placebo or randomization) Phase II trial. All participants receive the experimental drug MAS825 and are followed through screening, Treatment Period 1, and Treatment Period 2 over roughly 16 months. Main clinical response is assessed at Day 85 with additional assessments up to 15 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Canada, France, Germany, Italy, Netherlands, Spain, Turkey, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on adult-onset Still's disease

Clinical trials13 trials listed for adult-onset Still's diseaseEvery trial the registry lists for adult-onset Still's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in adult-onset Still's disease researchLatest monthly update: September 2026. Includes: MAS initial treatment. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 3, 2025
Primary completion
Apr 22, 2027 (estimated)
Study completion
May 17, 2028 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Sep 25, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Novartis Pharmaceuticals

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (23)

  • Cincinnati Childrens HospitalActive Not Recruiting

    Cincinnati, Ohio, 45229 · United States

  • Legacy Emanuel Research Hosp PortlandRecruiting

    Portland, Oregon, 97232 · United States

  • University of UtahRecruiting

    Salt Lake City, Utah, 84113 · United States

  • Novartis Investigative SiteWithdrawn

    Montreal, Quebec, H3T 1C5 · Canada

  • Novartis Investigative SiteWithdrawn

    Montreal, Quebec, H4A 3J1 · Canada

  • Novartis Investigative SiteRecruiting

    Bordeaux, 33076 · France

  • Novartis Investigative SiteRecruiting

    Bron, 69677 · France

  • Novartis Investigative SiteRecruiting

    Le Kremlin-Bicêtre, 94275 · France

  • Novartis Investigative SiteRecruiting

    Lille, 59037 · France

  • Novartis Investigative SiteRecruiting

    Paris, 75015 · France

Terms used on this page · explanations by MedicalUpdates.ai

ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Glucocorticoid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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