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NCT07203001PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

11/3/2025

Completion Date

5/17/2028

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

Detailed Description

This is a multicenter, open-label, single-arm study to assess clinical efficacy, safety and tolerability of MAS825 in participants (both pediatric and adult) with Still's disease who have had inadequate response to IL-1 and/or IL-6 or other available therapies. Participants with associated lung disease and/or macrophage activation syndrome may also be included. This study has three periods (Screening, Treatment Period 1, and Treatment Period 2) and a total duration of approximately 16 months.

Eligibility Criteria

Age Range: 1 years to 100 years

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.

Interventions

DRUG

MAS825

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Conditions

Still´s Disease

Locations

Cincinnati Childrens Hospital

Cincinnati, Ohio 45229

United States

Legacy Emanuel Research Hosp Portland

Portland, Oregon 97232

United States

Novartis Investigative Site

Montreal, Quebec H3T 1C5

Canada

Novartis Investigative Site

Montreal, Quebec H4A 3J1

Canada

Novartis Investigative Site

Bordeaux, 33076

France

Novartis Investigative Site

Bron, 69677

France

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275

France

Novartis Investigative Site

Lille, 59037

France

Novartis Investigative Site

Paris, 75015

France

Novartis Investigative Site

Paris, 75970

France

Novartis Investigative Site

Sankt Augustin, North Rhine-Westphalia 53757

Germany

Novartis Investigative Site

Heidelberg, 69120

Germany

Novartis Investigative Site

Münster, 48149

Germany

Novartis Investigative Site

Florence, FI 50139

Italy

Novartis Investigative Site

Genova, GE 16147

Italy

Novartis Investigative Site

Roma, RM 00165

Italy

Novartis Investigative Site

Utrecht, 3584 CX

Netherlands

Novartis Investigative Site

Esplugues, Barcelona 08950

Spain

Novartis Investigative Site

Madrid, 28046

Spain

Novartis Investigative Site

Valencia, 46026

Spain

Novartis Investigative Site

Istanbul, Fatih 34098

Turkey (Türkiye)

Novartis Investigative Site

Ankara, Sihhiye-Altindag 06230

Turkey (Türkiye)