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

Recruiting now · Phase 2

Conditions studied: Still´s Disease

In brief

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

Key facts

Study ID

NCT07203001

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2025-11-03

Expected to finish

2028-05-17

Last updated by the study team

2026-07-10

Who can join

Age: 1 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Ankara, Sihhiye-Altindag, Turkey (Türkiye) (enrolling)
• Legacy Emanuel Research Hosp Portland — Portland, Oregon, United States (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)
• Novartis Investigative Site — Valencia, Spain (enrolling)
• Novartis Investigative Site — Istanbul, Fatih, Turkey (Türkiye) (enrolling)
• Novartis Investigative Site — Bordeaux, France (enrolling)
• Novartis Investigative Site — Bron, France (enrolling)
• Novartis Investigative Site — Le Kremlin-Bicêtre, France (enrolling)
• Novartis Investigative Site — Lille, France (enrolling)
• Novartis Investigative Site — Paris, France (enrolling)
• Novartis Investigative Site — Paris, France (enrolling)
• Novartis Investigative Site — Sankt Augustin, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Heidelberg, Germany (enrolling)
• Novartis Investigative Site — Münster, Germany (enrolling)
• Novartis Investigative Site — Florence, FI, Italy (enrolling)
• Novartis Investigative Site — Genova, GE, Italy (enrolling)
• Novartis Investigative Site — Roma, RM, Italy (enrolling)
• Novartis Investigative Site — Utrecht, Netherlands (enrolling)
• Novartis Investigative Site — Esplugues, Barcelona, Spain (enrolling)
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Cincinnati Childrens Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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