Recruiting
Phase 2

MAS825

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07203001

Conditions

Still´s Disease

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

MAS825

Study Details

Brief summary:

The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease

Conditions

Still´s Disease

Study ID

NCT07203001

Start date

Nov 3, 2025

Status verified date

Aug, 2026

Completion date

May 17, 2028

Anticipated

Primary completion date

Apr 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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
  • Intolerance or inadequate response to available biologic therapy

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MAS825

Experimental drug

Interventions

MAS825

Experimental drug

Primary outcome measure

  • Number of participants with clinical response based on one set of response criteria [ Time Frame: Day 85 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Legacy Emanuel Research Hosp Portland

Recruiting

Portland, Oregon, United States, 97232

Contacts

Brenna Bogle

+1 503 413 5447bbogle@lhs.org

Principal Investigator:

Daniel Joseph Kingsbury

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Tressie Rollins

+1 415 515 8212tressie.rollins@hsc.utah.edu

Principal Investigator:

Aimee Ogden Hersh

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Still´s disease
  • pediatric
  • adult
  • sJIA
  • AOSD
  • Systemic Juvenile Idiopathic Arthritis
  • Adult Onset Still s disease
  • rheumatology
  • MAS825
  • arumakimig

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.