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NCT04641442 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
A Phase 2 study of NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 20
- Study locations
NCT04641442: Active Phase 2 study of NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations, sponsored by Novartis Pharmaceuticals.
NCT04641442 is a Phase 2 study of NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04641442, a Phase 2 study of NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
Primary Outcome
To determine the efficacy of MAS825 in prevention of flares in patients with monogenic IL-18 driven autoinflammatory diseases, including NLRC4-GOF, XIAP deficiency or CDC42 mutations
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MAS825
Study Locations (20)
Other
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Prague
- Ustav Imunologie 2 LF UK a FN Motol - Prague
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Chiba
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - London
- Great Ormond Street Hospital - London
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Cincinnati Childrens Hospital - Cincinnati
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
- Children´s Hospital of Philadelphia - Philadelphia
Texas
- Texas Childrens Hospital - Houston
- Texas Children´s Hospital - Houston
Washington
- Seattle Childrens Hospital - Seattle
- Seattle Children´s Hospital - Seattle
RM
- Bambino Gesu Hospital - Roma
- Novartis Investigative Site - Roma
CZ
- Centrum detske revmatologie a autoinflamatornich onemocneni - Prague
Catalonia
- Hospital Clinic Barcelona - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2032-04-07 |
| Phase | Phase 2 |
What the registry record for NCT04641442 still lists
NCT04641442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04641442 names 20 study sites across 8 states, led by Other, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04641442 about?
NCT04641442 is a clinical study titled "Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations". This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
What is the current status of trial NCT04641442?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-12-18. Estimated completion is 2032-04-07.
What conditions does trial NCT04641442 study?
This clinical trial studies the following conditions: NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations.
What interventions are being tested in trial NCT04641442?
The interventions under investigation include: Placebo (BIOLOGICAL), MAS825 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04641442?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04641442 being conducted?
This trial has 20 study locations across Ohio, Pennsylvania, Texas, Washington, CZ. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04641442's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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