NCT07203001 · Novartis Pharmaceuticals
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
What this study is about
The study is a phase II trial designed to evaluate the clinical effectiveness, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cincinnati, Ohio
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations