Actively Recruiting

Phase 2
Age: 1Year - 100Years
All Genders
NCT07203001

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

Led by Novartis Pharmaceuticals · Updated on 2026-04-21

20

Participants Needed

22

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 1 year or older with a diagnosis of Still's Disease
  • Active disease defined by elevated CRP or ferritin levels above the upper limit of normal
  • Presence of at least one of the following: fever (≥ 38°C) attributed to Still's Disease, rash attributed to Still's Disease, arthritis in multiple joints per ACP criteria, serositis, or macrophage activation syndrome activity as defined by ferritin and other biomarkers
  • Need for glucocorticoid treatment (prednisone or equivalent)
Not Eligible

You will not qualify if you...

  • Patients outside the required weight range
  • Ongoing or previous treatment with immunomodulatory drugs (except limited MAS825 use through managed access)
  • Glucocorticoid dose exceeding a set limit
  • Any significant medical condition posing unacceptable risk for MAS825 therapy
  • History of ongoing, chronic, or recurrent infections such as HIV, TB, HCV, or HBV, or signs of active infections
  • Receipt of live vaccinations within a specified time before MAS825 treatment
  • History of malignancies including post-transplant lymphoproliferative disorder within a set number of years
  • History of hypersensitivity to MAS825, related drugs, or any excipients
  • Pregnant or breastfeeding women
  • Women of child-bearing potential who do not agree to use required contraception
  • Other protocol-defined inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Cincinnati Childrens Hospital

Cincinnati, Ohio, United States, 45229

Actively Recruiting

2

Legacy Emanuel Research Hosp Portland

Portland, Oregon, United States, 97232

Actively Recruiting

3

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

4

Novartis Investigative Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

5

Novartis Investigative Site

Bordeaux, France, 33076

Actively Recruiting

6

Novartis Investigative Site

Bron, France, 69677

Actively Recruiting

7

Novartis Investigative Site

Le Kremlin-Bicêtre, France, 94275

Actively Recruiting

8

Novartis Investigative Site

Lille, France, 59037

Actively Recruiting

9

Novartis Investigative Site

Paris, France, 75015

Actively Recruiting

10

Novartis Investigative Site

Paris, France, 75970

Actively Recruiting

11

Novartis Investigative Site

Sankt Augustin, North Rhine-Westphalia, Germany, 53757

Actively Recruiting

12

Novartis Investigative Site

Heidelberg, Germany, 69120

Actively Recruiting

13

Novartis Investigative Site

Münster, Germany, 48149

Actively Recruiting

14

Novartis Investigative Site

Florence, FI, Italy, 50139

Actively Recruiting

15

Novartis Investigative Site

Genova, GE, Italy, 16147

Actively Recruiting

16

Novartis Investigative Site

Roma, RM, Italy, 00165

Actively Recruiting

17

Novartis Investigative Site

Utrecht, Netherlands, 3584 CX

Actively Recruiting

18

Novartis Investigative Site

Esplugues, Barcelona, Spain, 08950

Actively Recruiting

19

Novartis Investigative Site

Madrid, Spain, 28046

Actively Recruiting

20

Novartis Investigative Site

Valencia, Spain, 46026

Actively Recruiting

21

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye), 34098

Actively Recruiting

22

Novartis Investigative Site

Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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