Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency
A Phase 3 Open-Label Study of Safety, Pharmacokinetics, and Activity of Weekly Subcutaneous Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency
Sponsor: Immedica Pharma AB
Listed as NCT06582524, this observational or N/A phase trial focuses on Arginase 1 Deficiency and remains completed. Sponsored by Immedica Pharma AB, it has been updated 6 times since 2024, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)CAEB1102-301A is an open-label, single-arm, non-controlled, repeat dosing, multicentre study to evaluate the safety, PK, and activity (PD) of weekly SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are \< 24 months of age.
This study will consist of:
* A screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine
* A treatment period of 12 weeks
* A safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose.
CAEB1102-301A is an open-label, single-arm, non-controlled, repeat dosing, multicentre study to evaluate the safety, PK, and activity (PD) of weekly SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are \< 24 months of age.
This study will consist of:
* A screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine * A treatment period of 12 weeks * A safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose.
Status Flow
Change History
6 versions recorded-
May 4, 2026 — Present [daily]
Completed
Phase: PHASE3 → None
-
Dec 2025 — May 2026 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Sep 2025 — Dec 2025 [monthly]
Active Not Recruiting PHASE3
-
Aug 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Feb 2025 — Aug 2025 [monthly]
Recruiting PHASE3
▶ Show 1 earlier version
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Oct 2024 — Feb 2025 [monthly]
Recruiting PHASE3
First recorded
Aug 2024
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.
Contact Information
- Immedica Pharma AB
For direct contact, visit the study record on ClinicalTrials.gov .