20 Participants Needed

MAS825 for Still's Disease

Recruiting at 2 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Must be taking: Glucocorticoids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called MAS825, an experimental therapy for Still's disease, a rare inflammatory condition causing symptoms like fever, rash, and joint pain. The trial includes children and adults with active Still's disease, particularly those requiring medications like prednisone. Participants must not have received certain immune drugs previously. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the MAS825 trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have ongoing or previous treatment with immunomodulatory drugs. You may need to discuss your specific medications with the trial team.

Is there any evidence suggesting that MAS825 is likely to be safe for humans?

Research has shown that MAS825 is generally safe for people with Still's disease. Studies indicate that treatments targeting IL-6, such as MAS825, do not present major safety issues. Patients who have used similar treatments in the past have tolerated them well.

In other studies, drugs like MAS825 have proven effective, working well without causing serious side effects. This suggests that MAS825 should also be well-tolerated.

Since the trial is in Phase 2, MAS825 has already passed initial safety tests in humans. This indicates some evidence of safety, but researchers continue to collect more data to confirm this.12345

Why do researchers think this study treatment might be promising?

MAS825 is unique because it introduces a new approach to treating Still's Disease by potentially targeting specific inflammatory pathways more precisely than current treatments, like NSAIDs or corticosteroids. Researchers are excited about MAS825 because it may offer a more targeted mechanism of action, which could lead to fewer side effects and improved symptom control. This experimental drug represents hope for a more effective and safer treatment option for patients with Still's Disease.

What evidence suggests that MAS825 might be an effective treatment for Still's disease?

Research has shown that MAS825, the investigational treatment in this trial, may help treat Still's disease by targeting specific proteins in the body. In earlier studies, patients with severe forms of a similar condition, sJIA, responded well to MAS825. This drug blocks proteins called IL-1β and IL-18, which can cause inflammation. One study found that 40% of patients achieved complete disease control after two years. Another study showed that 50% of patients experienced significant improvement after three years. These results suggest that MAS825 could effectively manage symptoms of Still's disease.36789

Are You a Good Fit for This Trial?

This trial is for pediatric and adult patients with Still's Disease who have a fever, rash, joint pain or swelling, serositis (inflammation of tissues lining the lungs, heart, abdomen), or macrophage activation syndrome as indicated by certain blood markers. They must need steroids to manage their condition and be at least 1 year old.

Inclusion Criteria

* 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)
I am over 1 year old and have been diagnosed with Still's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MAS825 to evaluate clinical efficacy, safety, and tolerability

12 weeks
Regular visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Long-term follow-up

Participants are assessed for long-term safety and efficacy outcomes

15 months

What Are the Treatments Tested in This Trial?

Interventions

  • MAS825
Trial Overview The trial is testing MAS825 to see how effective and safe it is for treating Still's Disease in both children and adults. It's a phase II study which means they're looking at how well the drug works and checking its safety.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MAS825Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

Long-term efficacy of MAS825, a bispecific anti-IL1β and IL ...We report two patients affected by sJIA with severe and refractory MAS and high serum IL-18 levels, responding to dual blockade of IL-1β and IL-18.
Efficacy and safety of therapies for Still's disease and ...In the LTE phase, 40% achieved CID at 24 months and 50% acheived an aJIA-ACR90 response at 3 years. In another open-label study in sJIA, the CID ...
NCT03311854 | A Study to Investigate the Safety and ...The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD participants developing MAS.
The evolving treatment landscape in Still's diseaseIn 2025, Kernder and colleagues showed that first-line biological DMARD therapy in patients with AOSD led to greater sustained, event-free remission and fewer ...
EULAR/PReS recommendations for the diagnosis and ...These recommendations are the first consensus for the diagnosis and management of children and adults with Still's disease.
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and ...A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease.
Adult-Onset Still's Disease (AOSD) - PMC - NIHIL-6 inhibitors are generally safe, and no major concerns have been raised. Yokota [105] reported the safety data of one of the largest cohorts of children ...
Long-term efficacy of MAS825, a bispecific anti-IL1β and IL-18 ...Open-label, multicentre, dose- escalating phase II clinical trial on the safety and efficacy of tadeki- nig alfa (IL-18BP) in adult-onset Still's disease. Ann ...
Efficacy and safety of therapies for Still's disease and ...IL-1i and IL-6Ri show the highest level of efficacy in the treatment of Still's disease. For MAS, IL-1 and interferon-γ inhibition appear to be effective.
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