NCT04514367Phase 2Completed

An Open Label Study of ANX005 in Participants With, or at Risk for, Manifest Huntington's Disease

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.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2022-08-29Actual

Enrollment · participants28Actual

Source updated2026-08-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-07-01 · 2 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

Compare wording

− Before

Measure: ~~Safety and tolerability~~ of ~~intravenous~~ ~~ANX005~~ ~~administered~~ ~~for~~ up ~~to 22 weeks in subjects with, or at risk for, manifest Huntington's Disease~~ Measure: ~~Pharmacokinetics~~ (PK) of ANX005 Measure: ~~Pharmacodynamics~~ (PD) ~~effects~~ of ~~ANX005~~

+ After

Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Measure: Actual Dose of ANX005 Administered on Day 1 Measure: Actual Dose of ANX005 Administered on Week 22 Measure: Area Under the Concentration Versus Time Curve From Time 0 to t (AUC0-t) of ANX005 at Day 1 Measure: CSF Free Complement Component 1q (C1q) at Day 1 Measure: Blood Free C1q at Day 1 Measure: Change From Baseline in Complement C4a in CSF at Week 24 Measure: Change From Baseline in Complement C4a in CSF at Week 36 Measure: Change From Baseline in CSF NfL Level at Week 24 Measure: Change From Baseline in CSF NfL Level at Week 36 Measure: Change From Baseline in Blood NfL Level at Week 24 Measure: Change From Baseline in Blood NfL Level at Week 36

Primary completion date changed

− Before

~~28 Jan 2022~~

+ After

29 Aug 2022

Check registry source

Study details

Conditions studied

Huntington Disease

Treatments or interventions studied

ANX005Drug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); description: An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Serious AEs (SAEs) included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was any AE with an onset on or after the day of infusion through Week 36 (end of study). AEs were graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE): Grade: 1=Mild, 2=Moderate, 3=Severe or medically significant but not immediately life-threatening. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.; timeFrame: From first dose of study drug up to end of study (Week 36); measure: Actual Dose of ANX005 Administered on Day 1; timeFrame: Day 1; measure: Actual Dose of ANX005 Administered on Week 22; timeFrame: Week 22; measure: Area Under the Concentration Versus Time Curve From Time 0 to t (AUC0-t) of ANX005 at Day 1; timeFrame: Pre-dose up to 4 hours post-dose on Day 1; measure: CSF Free Complement Component 1q (C1q) at Day 1; timeFrame: Predose at Baseline (Day 1); measure: Blood Free C1q at Day 1; timeFrame: Predose at Baseline (Day 1); measure: Change From Baseline in Complement C4a in CSF at Week 24; timeFrame: Baseline, Week 24; measure: Change From Baseline in Complement C4a in CSF at Week 36; timeFrame: Baseline, Week 36; measure: Change From Baseline in CSF NfL Level at Week 24; timeFrame: Baseline, Week 24; measure: Change From Baseline in CSF NfL Level at Week 36; timeFrame: Baseline, Week 36; measure: Change From Baseline in Blood NfL Level at Week 24; timeFrame: Baseline, Week 24; measure: Change From Baseline in Blood NfL Level at Week 36; timeFrame: Baseline, Week 36

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.

How to read this history