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 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.

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

March 30 2026

Active Locations (22)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (22 locations)

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