A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
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
2 other identifiers
interventional
20
8 countries
22
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2025
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedStudy Start
First participant enrolled
November 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 24, 2029
April 21, 2026
April 1, 2026
3.6 years
September 9, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with clinical response based on one set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Day 85
Secondary Outcomes (6)
Number of participants with clinical response based on another set of response criteria
Day 85
Response based on a biomarker level
Baseline, Day 85
Change in physician assessment based on laboratory features of MAS825
Baseline, 15 months
Change from baseline in Glucocorticoid (GC) dose
Baseline, Day 85, Month 6, Month 12
Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument
Baseline, Day 85
- +1 more secondary outcomes
Study Arms (1)
MAS825
EXPERIMENTALExperimental drug
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2025
First Posted
October 2, 2025
Study Start
November 3, 2025
Primary Completion (Estimated)
May 24, 2029
Study Completion (Estimated)
May 24, 2029
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.