A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatri… (NCT07203001) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
United States, Canada, France20 participantsStarted 2025-11-03
Plain-language summary
The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in pediatric and adult participants with Still's disease
Who can participate
Age range1 Year – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 signifi…
What they're measuring
1
Number of participants with clinical response based on one set of response criteria