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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