ANNX

Annexon, Inc.

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7Trials in this database
10Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far

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.

Completion dates · Pro

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Latest recorded trial changes

· 2 fields changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

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

+ Updated value

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

The saved outcome text may be shortened. Check the source for full wording.

Primary completion date

Recorded edit
− Previous value

2022-01-28

+ Updated value

2022-08-29

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· 2 fields changed

Primary outcomes · main study measures

Text edit · unverified significance
− 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

The saved outcome text may be shortened. Check the source for full wording.

Enrollment · participant count

Recorded edit
− Previous value

count: 6; type: ACTUAL

+ Updated value

count: 7; type: ACTUAL

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· 1 field changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: Proportion of patients experiencing a best corrected visual acuity (BCVA) ≥15-letter loss from baseline through the primary timepoint as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at any two consecutive visits.

+ Updated value

measure: Proportion of Participants Experiencing a Best Corrected Visual Acuity (BCVA) ≥15-letter Loss from Baseline Through Month 15 as Assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Any Two Consecutive Visits

The saved outcome text may be shortened. Check the source for full wording.

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· 3 fields changed

Participant count type

Recorded edit
− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit
− Previous value

count: 630; type: ESTIMATED

+ Updated value

count: 659; type: ACTUAL

Recruitment status

Recorded edit
− Previous value

Recruiting

+ Updated value

Active not recruiting

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