A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
NCT ID: NCT07203001
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-11-03
2029-05-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MAS825
Experimental drug
MAS825
Experimental drug
Interventions
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MAS825
Experimental drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Legacy Emanuel Research Hosp Portland
Portland, Oregon, United States
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Kristin Hickey
Role: primary
Other Identifiers
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CMAS825J12201
Identifier Type: -
Identifier Source: org_study_id