A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
Recruiting
Phase 2Interventional Study
Still´s Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
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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
Trial Locations
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Status
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 Diseas…
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.
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