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This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
After being informed of study details and potential risks, all participants who provide written informed consent will undergo an up to 6-week screening period to determine eligibility. Participants who meet the eligibility criteria will receive two once-weekly intravenous (IV) infusions of ANX005. Participants will return to the clinic weekly through Week 10 for study assessments. The total duration of individual participation in this study will be up to 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANX005 | Experimental | Participants will receive two once-weekly doses of ANX005 at specific time points |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANX005 | Drug | ANX005 is provided as a solution for IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Day 1 through Day 71 |
| Maximum Change From Baseline in Hemoglobin Levels | 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. | Baseline up to Day 71 |
| Change From Baseline in Lactate Dehydrogenase Levels at Day 71 | 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. | Baseline, Day 71 |
| Change From Baseline in Percentage of Reticulocytes/Total Cells Count at Day 71 | 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. | Baseline, Day 71 |
| Change From Baseline in Haptoglobin Levels at Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Inhibition Complement CH50 From Baseline Through Day 71 | Change in percent inhibition complement CH50 from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005. A decrease form baseline indicated a better outcome. | Baseline, Days 2, 4, 8, 15, 22, 29, 36, 43, 50, 57, and 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Annexon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 01 | Rochester | Minnesota | 55905 | United States | ||
| Investigational Site 03 |
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Participants with wAIHA who met eligibility criteria were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | ANX005 | Participants were administered intravenous infusion of ANX005 on Day 1 and Day 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2022 | May 18, 2026 |
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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. |
| Baseline, Day 71 |
| Change From Baseline in Total Bilirubin Levels at Day 71 | 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. | Baseline, Day 71 |
| Change From Baseline in Indirect Bilirubin Levels at Day 71 | 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. | Baseline, Day 71 |
| Change From Baseline in Complement C4 Level Through Day 71 | 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. | Baseline, Days 2, 4, 8 (pre-dose and end of infusion), 15, 22, 29, 36, 43, 50, 57, and 71 |
| Change From Baseline in Complement C1q Level Through Day 71 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005. | Baseline, Days 2 (4 hours [hr] after Infusion and end of infusion), 4, 8 (pre-dose, 4 hr after Infusion, and end of infusion), 15, 22, 29, 36, 43, 50, 57, and 71 |
| Melbourne |
| Australia |
| Investigational Site 04 | Vienna | Austria |
| Investigational Site 02 | Sofia | Bulgaria |
| Received at Least 1 Dose of Study Drug |
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| NOT COMPLETED |
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Safety Population: all participants who received any amount of ANX005.
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| ID | Title | Description |
|---|---|---|
| BG000 | ANX005 | Participants were administered intravenous infusion of ANX005 on Day 1 and Day 8. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Number | participants | Day 1 through Day 71 |
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| Primary | Maximum Change From Baseline in Hemoglobin Levels | 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. | Safety Population: all participants who received any amount of ANX005. Number analyzed' = participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | grams/deciliters (dL) | Baseline up to Day 71 |
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| Primary | Change From Baseline in Lactate Dehydrogenase Levels at Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Mean | Standard Deviation | units per liter (L) | Baseline, Day 71 |
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| Primary | Change From Baseline in Percentage of Reticulocytes/Total Cells Count at Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Mean | Standard Deviation | percentage of reticulocytes/total cells | Baseline, Day 71 |
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| Primary | Change From Baseline in Haptoglobin Levels at Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Mean | Standard Deviation | milligrams (mg)/dL | Baseline, Day 71 |
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| Primary | Change From Baseline in Total Bilirubin Levels at Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Mean | Standard Deviation | micromole (µmol)/L | Baseline, Day 71 |
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| Primary | Change From Baseline in Indirect Bilirubin Levels at Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. | Posted | Mean | Standard Deviation | µmol/L | Baseline, Day 71 |
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| Secondary | Change in Percent Inhibition Complement CH50 From Baseline Through Day 71 | Change in percent inhibition complement CH50 from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005. A decrease form baseline indicated a better outcome. | Safety Population: all participants who received any amount of ANX005.Number analyzed' = participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | activity percent | Baseline, Days 2, 4, 8, 15, 22, 29, 36, 43, 50, 57, and 71 |
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| Secondary | Change From Baseline in Complement C4 Level Through Day 71 | 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. | Safety Population: all participants who received any amount of ANX005. Number analyzed' = participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Days 2, 4, 8 (pre-dose and end of infusion), 15, 22, 29, 36, 43, 50, 57, and 71 |
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| Secondary | Change From Baseline in Complement C1q Level Through Day 71 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005. | Safety Population: all participants who received any amount of ANX005. Number analyzed' = participants evaluable at specified timepoint. | Posted | Mean | Standard Deviation | nanograms/milliliters | Baseline, Days 2 (4 hours [hr] after Infusion and end of infusion), 4, 8 (pre-dose, 4 hr after Infusion, and end of infusion), 15, 22, 29, 36, 43, 50, 57, and 71 |
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Day 1 through Day 71
All-cause mortality was assessed for all enrolled participants. AEs were assessed for all participants who received any amount of ANX005 (Safety Population).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANX005 | Participants were administered intravenous infusion of ANX005 on Day 1 and Day 8. | 0 | 7 | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Warm type haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Face oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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None reported
Written approval from the Sponsor is required before disclosing any information relative to this clinical study, and no publications initiated by Investigators may be published until all protocol-defined results are published in a manuscript. The details and processes of producing and reviewing reports, manuscripts, and presentations based on the data from this study are described in the clinical study agreement between the Sponsor and the institution of the Investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Annexon, Inc. | 650-822-5500 | clinicaltrials@annexonbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2022 | May 18, 2026 | SAP_001.pdf |
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| Newborns (0-27 days) |
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| Infants and toddlers (28 days-23 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Adults (18-64 years) |
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| From 65-84 years |
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| 85 years and over |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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