Clinical Trials in Italy / NCT07203001
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
Condition(s) studied
Still´s Disease
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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