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Recruiting Phase 2 NCT07203001

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

Phase 2 – studying effectiveness and dosage
Conditions: Still´s Disease

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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
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 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.
Interventions
MAS825
DRUG
Locations 22
Canada (2)
Novartis Investigative Site
Montreal , Quebec
Novartis Investigative Site
Montreal , Quebec
France (6)
Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Bron
Novartis Investigative Site
Le Kremlin-Bicêtre
Novartis Investigative Site
Lille
Novartis Investigative Site
Paris
Novartis Investigative Site
Paris
Germany (3)
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Münster
Novartis Investigative Site
Sankt Augustin , North Rhine-Westphalia
Italy (3)
Novartis Investigative Site
Florence , FI
Novartis Investigative Site
Genova , GE
Novartis Investigative Site
Roma , RM
Netherlands (1)
Novartis Investigative Site
Utrecht
Spain (3)
Novartis Investigative Site
Esplugues , Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Valencia
Turkey (2)
Novartis Investigative Site
Ankara , Sihhiye-Altindag
Novartis Investigative Site
Istanbul , Fatih
United States (2)
Cincinnati Childrens Hospital
Cincinnati , Ohio
Legacy Emanuel Research Hosp Portland
Portland , Oregon
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
100 Years
Healthy volunteers
No
Start date
03.11.2025
Completion date
24.05.2029
Registry ID
NCT07203001
Source
clinicaltrials.gov
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