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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
Cohort 2 specific inclusion criteria: Patients with a genetic diagnosis of NLRC4-GOF, XIAP deficiency, or CDC42 mutations who are being treated with MAS825 in a Novartis Managed Access Program (MAP).
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 below
Select...
I weigh at least 3 kg.
Select...
I have NLRC4-GOF, XIAP deficiency, or CDC42 mutations and am in a Novartis MAP for MAS825.
Select...
I have a genetic condition related to NLRC4, XIAP, or CDC42 and show signs of inflammation.

MASter-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening through eos (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through eos (end of study) for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 140 Patients • NCT04382651
16%
Acute respiratory failure
13%
Acute kidney injury
9%
Pneumonia bacterial
9%
Acute respiratory distress syndrome
7%
Respiratory failure
7%
Hypoxia
7%
Hypotension
6%
Atrial fibrillation
4%
Septic shock
4%
Anxiety
3%
Urinary tract infection
3%
Sepsis
3%
COVID-19
3%
COVID-19 pneumonia
3%
Multiple organ dysfunction syndrome
3%
Pancytopenia
3%
Cardiac arrest
1%
Cerebrovascular accident
1%
Fungaemia
1%
Respiratory arrest
1%
Nephropathy
1%
Haemophagocytic lymphohistiocytosis
1%
Acute coronary syndrome
1%
Cardiac failure acute
1%
Cardiogenic shock
1%
Myocarditis
1%
Hypothermia
1%
Metabolic encephalopathy
1%
Pneumomediastinum
1%
Pneumothorax
1%
Pulmonary embolism
1%
Distributive shock
1%
Disseminated intravascular coagulation
1%
Pneumonia klebsiella
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Metabolic acidosis
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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,853 Previous Clinical Trials
4,197,460 Total Patients Enrolled

Media Library

MAS825 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04641442 — Phase 2
X-linked Autoinflammation with Infantile Enterocolitis Syndrome Research Study Groups: MAS825, Placebo
X-linked Autoinflammation with Infantile Enterocolitis Syndrome Clinical Trial 2023: MAS825 Highlights & Side Effects. Trial Name: NCT04641442 — Phase 2
MAS825 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641442 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has MAS825 been granted regulatory clearance by the Food and Drug Administration?

"MAS825 has been granted a safety rating of 2, given that it is in the midst of Phase 2 trials. While there is evidence attesting to its security at this stage, efficacy remains unconfirmed."

Answered by AI

What other research projects have been completed that involve MAS825?

"MAS825 was initially tested at Novartis Investigative Site in 2019, with over 18325 trials having been concluded. At the present moment, two studies are actively seeking patients and both of those can be found in Montreal, Quebec."

Answered by AI

In what geographical areas is this scientific experiment taking place?

"As of now, this clinical trial is sourcing participants from a total of 6 sites. These are situated in Montreal, Cincinnati and Seattle alongside 3 other spots. To minimize the amount of travel needed to take part, it's recommended that you pick the closest clinic for enrollment."

Answered by AI

How many participants are currently being observed in this clinical investigation?

"The pharmaceutical company Novartis Pharmaceuticals is sponsoring the trial and will be administering it from Montreal, Quebec and Cincinnati, Ohio. To conduct this research 8 participants fulfilling specific criteria must be identified."

Answered by AI

Is this research endeavor recruiting participants yet?

"Clinicaltrials.gov reports that this medicinal experiment is currently enrolling patients with the first post on December 18th 2020, and last update occurring October 31st 2022."

Answered by AI

What makes this experimental trial distinct from others?

"MAS825 has been investigated since 2019, when Novartis Pharmaceuticals sponsored its first clinical trial involving 200 participants. After the successful completion of Phase 1, MAS825 was granted approval for its second testing phase. Currently there are active research studies in 23 cities and 15 countries dedicated to examining this medication's efficacy."

Answered by AI
~5 spots leftby Jun 2025