NCT04691570Phase 2Completed

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-01-17Actual

Enrollment · participants7Actual

Source updated2026-06-30Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-12 · 2 fields changed

Primary outcomes · main study measures

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− Previous value

measure: Safety: Treatment-emergent adverse events (TEAEs); measure: Change in disease activity biomarkers

+ Updated value

measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs); measure: Maximum Change From Baseline in Hemoglobin Levels; measure: Change From Baseline in Lactate Dehydrogenase Levels at Day 71; measure: Change From Baseline in Percentage of Reticulocytes/Total Cells Count at Day 71; measure: Change From Baseline in Haptoglobin Levels at Day 71; measure: Change From Baseline in Total Bilirubin Levels at Day 71; measure: Change From Baseline in Indirect Bilirubin Levels at Day 71

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Enrollment · participant count

Recorded edit

− Previous value

count: 6; type: ACTUAL

+ Updated value

count: 7; type: ACTUAL

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Study details

Conditions studied

Warm Autoimmune Hemolytic Anemia (wAIHA)

Treatments or interventions studied

ANX005Drug

Primary outcomes · main study measures

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measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs); description: An adverse event (AE) was any untoward medical occurrence in a participant who had been administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the product and therefore could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product. An AE could arise with any use, route of administration, formulation, dose (including an overdose), or when used in combination with another pharmaceutical product. A TEAE was an AE with an onset date/time after the first infusion of ANX005 until the end of the study. A summary of serious and all other non-serious adverse events regardless of causality is located in the Adverse Events module.; timeFrame: Day 1 through Day 71; measure: Maximum Change From Baseline in Hemoglobin Levels; description: Maximum change from Baseline was calculated as the maximum post-Baseline value observed up to Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline up to Day 71; measure: Change From Baseline in Lactate Dehydrogenase Levels at Day 71; description: Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline, Day 71; measure: Change From Baseline in Percentage of Reticulocytes/Total Cells Count at Day 71; description: Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline, Day 71; measure: Change From Baseline in Haptoglobin Levels at Day 71; description: Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline, Day 71; measure: Change From Baseline in Total Bilirubin Levels at Day 71; description: Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline, Day 71; measure: Change From Baseline in Indirect Bilirubin Levels at Day 71; description: Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.; timeFrame: Baseline, Day 71

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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