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
Eligibility
Sex
ALL
Min age
1 Year
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with clinical response based on one set of response criteria — Day 85 Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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