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MAS825 for Autoinflammatory Diseases (MASter-1 Trial)
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For all Patients: Male and female patients weighing at least 3 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening through eos
Awards & highlights
MASter-1 Trial Summary
This trial is testing a new drug to see if it is effective and safe for patients with NLRC4-GOF.
Who is the study for?
This trial is for patients with specific genetic autoinflammatory diseases (NLRC4-GOF, XIAP deficiency, or CDC42 mutations) who weigh at least 3 kg. Participants must provide informed consent and have active disease symptoms. Excluded are those with hypersensitivity to study drugs, positive HIV/Hepatitis tests, tuberculosis infection, certain CDC42 mutation syndromes, recent anti-rejection/immunomodulatory drug use except some exceptions like glucocorticoids.Check my eligibility
What is being tested?
The trial is testing the effectiveness of MAS825 compared to a placebo in treating autoinflammatory conditions caused by specific genetic mutations. It's a Phase 2 study focusing on safety and how well patients tolerate the treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include reactions related to immune system modulation such as inflammation or allergic responses due to hypersensitivity history exclusion criteria.
MASter-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 3 kg.
MASter-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening through eos (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through eos (end of study)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Occurrence of disease flare in patients with MAS825 treated patients compared with placebo during Period 2 assessed by Physician's Global Assessment and inflammatory markers
Secondary outcome measures
All cohorts: Confirmation of serological markers of MAS825
All cohorts: Number and severity of safety assessments and adverse events
All cohorts: Patient / Parent global assessment of disease activity (PPGA) scale
+5 moreSide effects data
From 2021 Phase 2 trial • 140 Patients • NCT0438265116%
Acute respiratory failure
13%
Acute kidney injury
9%
Pneumonia bacterial
9%
Acute respiratory distress syndrome
7%
Hypotension
7%
Respiratory failure
7%
Hypoxia
6%
Atrial fibrillation
4%
Septic shock
4%
Anxiety
3%
Multiple organ dysfunction syndrome
3%
Cardiac arrest
3%
COVID-19 pneumonia
3%
COVID-19
3%
Sepsis
3%
Urinary tract infection
3%
Pancytopenia
1%
Metabolic acidosis
1%
Haemophagocytic lymphohistiocytosis
1%
Alanine aminotransferase increased
1%
Cardiac failure acute
1%
Fungaemia
1%
Cerebrovascular accident
1%
Distributive shock
1%
Respiratory arrest
1%
Nephropathy
1%
Acute coronary syndrome
1%
Cardiogenic shock
1%
Myocarditis
1%
Hypothermia
1%
Metabolic encephalopathy
1%
Pneumomediastinum
1%
Pneumothorax
1%
Pulmonary embolism
1%
Disseminated intravascular coagulation
1%
Pneumonia klebsiella
1%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAS825 + SoC
Placebo + SoC
Total
MASter-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MAS825Experimental Treatment1 Intervention
Experimental drug
Group II: PlaceboPlacebo Group1 Intervention
matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAS825
2019
Completed Phase 3
~230
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for X-linked Autoinflammation with Infantile Enterocolitis Syndrome (XLAIES) involve immunomodulatory agents that target specific immune pathways to control the hyperactive immune response. These treatments are essential for managing the excessive inflammation seen in XLAIES patients.
For example, agents targeting IL-18 driven autoinflammatory pathways, similar to those studied in the MAS825 trial, can help reduce inflammation by modulating the activity of immune cells involved in these pathways. This targeted approach is crucial for improving clinical outcomes and reducing the severity of symptoms in XLAIES patients.
Case report: Novel treatment regimen for <i>enterovirus</i> encephalitis in SCID.Case Report: Refractory Autoimmune Gastritis Responsive to Abatacept in LRBA Deficiency.Necrotizing enterocolitis as an adverse effect of recombinant interleukin-2 and Ch14.18 in maintenance therapy for high-risk neuroblastoma.
Case report: Novel treatment regimen for <i>enterovirus</i> encephalitis in SCID.Case Report: Refractory Autoimmune Gastritis Responsive to Abatacept in LRBA Deficiency.Necrotizing enterocolitis as an adverse effect of recombinant interleukin-2 and Ch14.18 in maintenance therapy for high-risk neuroblastoma.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,869 Previous Clinical Trials
4,200,186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh at least 3 kg.I agree to use effective birth control during MAS825 therapy.I have NLRC4-GOF, XIAP deficiency, or CDC42 mutations and am in a Novartis MAP for MAS825.I have a genetic condition related to NLRC4, XIAP, or CDC42 and show signs of inflammation.I tested positive for tuberculosis recently.You have medical conditions or problems that the doctor believes would make it too risky for you to receive MAS825 therapy.I haven't taken certain immune system affecting drugs recently before starting MAS825, except for some allowed ones.I have Takenouchi-Kosaki syndrome with CDC42 mutation.I weigh more than 160 kg.I have not received any live vaccines in the month before starting MAS825, and I won't during or for 3 months after the trial.I don't have any serious ongoing infections, except for chronic EBV.
Research Study Groups:
This trial has the following groups:- Group 1: MAS825
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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