Status:
RECRUITING
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Still´s Disease
Eligibility:
All Genders
1-100 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07203001
Start Date
November 3 2025
End Date
May 24 2029
Last Update
December 30 2025
Active Locations (4)
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1
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
2
Legacy Emanuel Research Hosp Portland
Portland, Oregon, United States, 97232
3
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1C5
4
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1