CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 18 enrolled
Drug / intervention
Lumasirandrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03905694
NCT03905694Phase 3Completed
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ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1

Alnylam Pharmaceuticals·interventional·Posted Apr 5, 2019·Updated Feb 14, 2025

In Brief

A Phase 3 clinical trial evaluating Lumasiran for Primary Hyperoxaluria and Primary Hyperoxaluria Type 1 (PH1). Completed, enrolled 18 participants across 9 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hyperoxaluria, Primary Hyperoxaluria Type 1 (PH1)
CountriesFrance, Germany, Israel, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 5, 2019
Enrollment StartApr 22, 2019
Primary CompletionJun 29, 2020
Study CompletionJul 26, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.2 years ago

Interventions

Lumasirandrug

Lumasiran will be administered by subcutaneous (SC) injection.