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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
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 2
Sponsor: Novartis Pharmaceuticals

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 30 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

21 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Canada, France, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), United States

Quebec, Canada: 1
North Rhine-Westphalia, Germany: 1
FI, Italy: 1
GE, Italy: 1
RM, Italy: 1
Barcelona, Spain: 1
Fatih, Turkey (Türkiye): 1
Sihhiye-Altindag, Turkey (Türkiye): 1
Ohio, United States: 1
Oregon, United States: 1
Utah, United States: 1

Sample of listed locations

Novartis Investigative Site — Montreal, Quebec, H3T 1C5, Canada — Site recruitment status not specified in the registry data
Novartis Investigative Site — Bordeaux, 33076, France — Site recruitment status not specified in the registry data
Novartis Investigative Site — Bron, 69677, France — Site recruitment status not specified in the registry data
Novartis Investigative Site — Le Kremlin-Bicêtre, 94275, France — Site recruitment status not specified in the registry data
Novartis Investigative Site — Lille, 59037, France — Site recruitment status not specified in the registry data
Novartis Investigative Site — Paris, 75015, France — Site recruitment status not specified in the registry data
Novartis Investigative Site — Sankt Augustin, North Rhine-Westphalia, 53757, Germany — Site recruitment status not specified in the registry data
Novartis Investigative Site — Heidelberg, 69120, Germany — Site recruitment status not specified in the registry data
Novartis Investigative Site — Münster, 48149, Germany — Site recruitment status not specified in the registry data
Novartis Investigative Site — Florence, FI, 50139, Italy — Site recruitment status not specified in the registry data
Novartis Investigative Site — Genova, GE, 16147, Italy — Site recruitment status not specified in the registry data
Novartis Investigative Site — Roma, RM, 00165, Italy — Site recruitment status not specified in the registry data
Novartis Investigative Site — Utrecht, 3584 CX, Netherlands — Site recruitment status not specified in the registry data
Novartis Investigative Site — Esplugues, Barcelona, 08950, Spain — Site recruitment status not specified in the registry data
Novartis Investigative Site — Madrid, 28046, Spain — Site recruitment status not specified in the registry data
Novartis Investigative Site — Valencia, 46026, Spain — Site recruitment status not specified in the registry data
Novartis Investigative Site — Istanbul, Fatih, 34098, Turkey (Türkiye) — Site recruitment status not specified in the registry data
Novartis Investigative Site — Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye) — Site recruitment status not specified in the registry data
Cincinnati Childrens Hospital — Cincinnati, Ohio, 45229, United States — Site recruitment status not specified in the registry data
Legacy Emanuel Research Hosp Portland — Portland, Oregon, 97232, United States — Site recruitment status not specified in the registry data
University of Utah — Salt Lake City, Utah, 84113, United States — Site recruitment status not specified in the registry data

Study details

Start date: November 3, 2025
Primary completion date: April 22, 2027
First posted: October 2, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07203001
Registry last updated: September 9, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07203001 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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