Thinking of joining a study?

Register your interest

Become a volunteer?

NCT07203001 | RECRUITING | Still´s Disease

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

Condition or disease

Still´s Disease

Intervention/treatment

MAS825

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-11-03
Estimated Primary Completion Date : 2029-05-24
Estimated Study Completion Date : 2029-05-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease

Location Details

NCT07203001

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

Cincinnati Childrens Hospital

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Oregon

Legacy Emanuel Research Hosp Portland

Portland, Oregon, United States, 97232

RECRUITING

Canada, Quebec

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1C5

RECRUITING

Canada, Quebec

Novartis Investigative Site

Montreal, Quebec, Canada, H4A 3J1