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MAS825 treatment for children and adults 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

Phase 2 Interventional Novartis · NCT07203001

This trial will test whether MAS825 helps children and adults with active Still's disease and is safe and tolerable.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment20 (estimated)
Ages1 Year to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsprednisone
Locations22 sites (Cincinnati, Ohio and 21 other locations)
Trial IDNCT07203001 on ClinicalTrials.gov

What this trial studies

This phase II interventional trial gives MAS825 to pediatric and adult participants with active Still's disease to measure clinical benefit and safety. Participants must have elevated CRP or ferritin and at least one clinical sign such as fever, rash, arthritis, serositis, or macrophage activation syndrome, and require glucocorticoids. Key outcomes include changes in symptoms, inflammatory markers, glucocorticoid use, and adverse events. The trial is sponsored by Novartis and enrolling at sites in Cincinnati, Portland, and Montreal.

Who should consider this trial

Good fit: Ideal candidates are people aged 1 year and older with active Still's disease (elevated CRP or ferritin plus fever, rash, arthritis, serositis, or MAS) who currently need glucocorticoids and meet the study's weight and medication restrictions.

Not a fit: Patients whose disease is already controlled without elevated inflammatory markers, those outside the allowed weight range, or those with recent or ongoing immunomodulatory treatments may not benefit from or be eligible for this trial.

Why it matters

Potential benefit: If successful, MAS825 could reduce inflammation and disease flares and lower the need for glucocorticoids in people with Still's disease.

How similar studies have performed: Other targeted biologic therapies for Still's disease, particularly IL-1 and IL-6 inhibitors, have shown clinical benefit, but MAS825 is a newer agent with limited prior data.

Eligibility criteria

Show full inclusion / exclusion 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
* Need for glucocorticoids (prednisone or equivalent)

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 this trial is running

Cincinnati, Ohio and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Still´s DiseaseStill´s diseasepediatricadultJIAAOSDJuvenile Idiopathic ArthritisAdult Onset Still s disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.