BridgeMD
Tests treatment safety and results for Still´s Disease
Official title A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
ClinicalTrials.gov ID: NCT07203001
What this study is testing
What is MAS825?
MAS825 is an investigational medicine, being studied as a potential treatment for still´s disease.
Also referred to as Arumakimig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 100
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Montreal, Quebec, Canada
- Bordeaux, France
- Bron, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Paris, France
- Sankt Augustin, North Rhine-Westphalia, Germany
- Heidelberg, Germany
- Münster, Germany
- Florence, FI, Italy
- Genova, GE, Italy
- Roma, RM, Italy
- Utrecht, Netherlands
- Esplugues, Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
- Istanbul, Fatih, Turkey (Türkiye)
- Ankara, Sihhiye-Altindag, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States; Portland, Oregon, United States; Montreal, Quebec, Canada; Bordeaux, France; Bron, France; Le Kremlin-Bicêtre, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.