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

April 20, 2026 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Novartis Investigative Site
      • Bron, France, 69677
        • Recruiting
        • Novartis Investigative Site
      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • Novartis Investigative Site
      • Lille, France, 59037
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75015
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75970
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Sankt Augustin, North Rhine-Westphalia, Germany, 53757
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • FI
      • Florence, FI, Italy, 50139
        • Recruiting
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16147
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Barcelona
      • Esplugues, Barcelona, Spain, 08950
        • Recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Recruiting
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital
        • Principal Investigator:
          • Alexei Grom
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97232
        • Recruiting
        • Legacy Emanuel Research Hosp Portland
        • Principal Investigator:
          • Daniel Joseph Kingsbury
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MAS825
Experimental drug
Drug: MAS825
Experimental drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical response based on one set of response criteria
Time Frame: Day 85
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical response based on another set of response criteria
Time Frame: Day 85
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Day 85
Response based on a biomarker level
Time Frame: Baseline, Day 85
To evaluate the efficacy of MAS825 in reducing clinical disease activity
Baseline, Day 85
Change in physician assessment based on laboratory features of MAS825
Time Frame: Baseline, 15 months
To assess the effect of MAS825 on macrophage activation syndrome
Baseline, 15 months
Change from baseline in Glucocorticoid (GC) dose
Time Frame: Baseline, Day 85, Month 6, Month 12
To evaluate the efficacy of MAS825 as a glucocorticoid-sparing agent
Baseline, Day 85, Month 6, Month 12
Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument
Time Frame: Baseline, Day 85
To evaluate the efficacy of MAS825 in improving participant's quality of life
Baseline, Day 85
Clinically inactive disease whilst on non-treatment dose corticosteroid at any time during the study
Time Frame: 15 months

The number of participants with inactive disease will be assessed. Disease activity will be evaluated by the investigator based on physical examination and laboratory parameters.

Inactive disease is defined according to protocol-specific criteria, which include clinical signs, laboratory values, and physician assessment.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

May 24, 2029

Study Completion (Estimated)

May 24, 2029

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

September 29, 2025

First Posted (Actual)

October 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMAS825J12201
  • 2024-520208-25 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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