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NCT07203001From ClinicalTrials.govRecruiting

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

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

  • Still´s Disease

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
30
Started
3 November 2025
Main results due
22 April 2027
Study sites
23
Registry updated
25 September 2026

Can you take part?

  • Aged 1 year and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(23)

  • Cincinnati Childrens Hospital

    Cincinnati, Ohio, United States

    Active, not recruiting

  • Legacy Emanuel Research Hosp Portland

    Portland, Oregon, United States

    Recruiting

  • University of Utah

    Salt Lake City, Utah, United States

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, Canada

    Withdrawn

  • Novartis Investigative Site

    Montreal, Quebec, Canada

    Withdrawn

  • Novartis Investigative Site

    Bordeaux, France

    Recruiting

  • Novartis Investigative Site

    Bron, France

    Recruiting

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, France

    Recruiting

  • Novartis Investigative Site

    Lille, France

    Recruiting

  • Novartis Investigative Site

    Paris, France

    Recruiting

  • Novartis Investigative Site

    Paris, France

    Recruiting

  • Novartis Investigative Site

    Sankt Augustin, North Rhine-Westphalia, Germany

    Recruiting

  • Novartis Investigative Site

    Heidelberg, Germany

    Recruiting

  • Novartis Investigative Site

    Münster, Germany

    Recruiting

  • Novartis Investigative Site

    Florence, FI, Italy

    Recruiting

  • Novartis Investigative Site

    Genova, GE, Italy

    Recruiting

  • Novartis Investigative Site

    Roma, RM, Italy

    Recruiting

  • Novartis Investigative Site

    Utrecht, Netherlands

    Active, not recruiting

  • Novartis Investigative Site

    Esplugues, Barcelona, Spain

    Recruiting

  • Novartis Investigative Site

    Madrid, Spain

    Recruiting

  • Novartis Investigative Site

    Valencia, Spain

    Recruiting

  • Novartis Investigative Site

    Istanbul, Fatih, Turkey (Türkiye)

    Recruiting

  • Novartis Investigative Site

    Ankara, Sihhiye Altindag, Turkey (Türkiye)

    Recruiting

Showing 23 of 23 sites. 19 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07203001. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult P | Trialion