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

Not Applicable

Not yet recruiting

• Conditions: Still´s Disease
• Interventions: Drug: MAS825

• Registration Number: NCT07203001
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-10-11
• Primary Completion: 2029-05-02
• Study Completion: 2029-05-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAS825	MAS825	Experimental drug

Primary Outcome Measures

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

Secondary Outcome Measures

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