Status:
APPROVED_FOR_MARKETING
Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
CD55-Deficient Protein-Losing Enteropathy
Eligibility:
All Genders
1+ years
Brief Summary
The program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with Protein-Losing Enteropathy (PLE). CD55-deficient PLE/CHAPLE...
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis (frameshift, nonsense mutations) as defined in the protocol
- Written informed consent from parent/guardian for minor patients
- Written assent from minor patients as appropriate (eg, above the age of 6 years or the applicable age per local regulatory requirements)
- Key
Exclusion
- Patients who discontinued the prior pozelimab study due to safety or lack of efficacy
- Considered by the treating physician as inappropriate for this program for any reason as defined in the protocol
- NOTE: Other protocol defined inclusion / exclusion criteria apply
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06003881
Last Update
November 7 2025
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