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Recruiting Phase 2

A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease

NCT07203001 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-11-03
Last updated
2026-09-25

Condition(s) studied

Still´s Disease

Investigational drug(s) / intervention(s)

MAS825 →

MAS825: Experimental drug

Study summary

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.

Trial sites (23)

FacilityCityRegionStatus
Cincinnati Childrens Hospital Cincinnati Ohio Active Not Recruiting
Legacy Emanuel Research Hosp Portland Portland Oregon Recruiting
University of Utah Salt Lake City Utah Recruiting
Novartis Investigative Site Montreal Quebec Withdrawn
Novartis Investigative Site Montreal Quebec Withdrawn
Novartis Investigative Site Bordeaux France Recruiting
Novartis Investigative Site Bron France Recruiting
Novartis Investigative Site Le Kremlin-Bicêtre France Recruiting
Novartis Investigative Site Lille France Recruiting
Novartis Investigative Site Paris France Recruiting
Novartis Investigative Site Paris France Recruiting
Novartis Investigative Site Sankt Augustin North Rhine-Westphalia Recruiting
Novartis Investigative Site Heidelberg Germany Recruiting
Novartis Investigative Site Münster Germany Recruiting
Novartis Investigative Site Florence FI Recruiting
Novartis Investigative Site Genova GE Recruiting
Novartis Investigative Site Roma RM Recruiting
Novartis Investigative Site Utrecht Netherlands Active Not Recruiting
Novartis Investigative Site Esplugues Barcelona Recruiting
Novartis Investigative Site Madrid Spain Recruiting
Novartis Investigative Site Valencia Spain Recruiting
Novartis Investigative Site Istanbul Fatih Recruiting
Novartis Investigative Site Ankara Sihhiye Altindag Recruiting
Official registry record

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.

View NCT07203001 on ClinicalTrials.gov ↗ ← All trials in Italy