A Phase 2 interventional study of ANX005 in Warm Autoimmune Hemolytic Anemia (wAIHA), sponsored by Annexon, Inc.. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Annexon, Inc. · Phase 2, Interventional, and Treatment
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.
103 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 39 are open to participants now.
This study's enrollment of 7 is below the median of 23 across 78 interventional studies indexed under Anemia, Hemolytic, Autoimmune.
Browse Anemia, Hemolytic, Autoimmune studies →Annexon, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive two once-weekly doses of ANX005 at specific time points
Drug: ANX005
ANX005 is provided as a solution for IV infusion
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 71
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 71
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.
Time frame: Baseline, Days 2, 4, 8, 15, 22, 29, 36, 43, 50, 57, and 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.
Time frame: 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.
Time frame: 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
| Milestone | ANX005 |
|---|---|
| Started | 7 |
| Received at least 1 dose of study drug | 6 |
| Completed | 6 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| participants | ANX005 |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 6 |
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.
| grams/deciliters (dL) | ANX005 |
|---|---|
| Baseline | 9.03 ± 0.653 |
| Maximum Change from Baseline | 1.30 ± 0.846 |
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.
| units per liter (L) | ANX005 |
|---|---|
| Baseline | 339.8 ± 84.88 |
| Change from Baseline | 7.8 ± 70.02 |
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.
| percentage of reticulocytes/total cells | ANX005 |
|---|---|
| Baseline | 6.58 ± 4.706 |
| Change from Baseline | 0.77 ± 1.607 |
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.
| milligrams (mg)/dL | ANX005 |
|---|---|
| Baseline | 9.0 ± 14.21 |
| Change from Baseline | 1.0 ± 8.99 |
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.
| micromole (µmol)/L | ANX005 |
|---|---|
| Baseline | 34.43 ± 22.848 |
| Change from baseline | 8.55 ± 18.940 |
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.
| µmol/L | ANX005 |
|---|---|
| Baseline | 17.22 ± 12.008 |
| Change from Baseline | 4.75 ± 11.951 |
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.
| activity percent | ANX005 |
|---|---|
| Baseline | 27.38 ± 11.481 |
| Change from Baseline: Day 2 | -12.50 ± 11.747 |
| Change from Baseline: Day 4 | -12.50 ± 11.747 |
| Change from Baseline: Day 8 | -12.50 ± 11.747 |
| Change from Baseline: Day 15 | -12.50 ± 11.747 |
| Change from Baseline: Day 22 | -12.50 ± 11.747 |
| Change from Baseline: Day 29 | -11.43 ± 10.722 |
| Change from Baseline: Day 36 | -0.13 ± 11.777 |
| Change from Baseline: Day 43 | 4.95 ± 14.850 |
| Change from Baseline: Day 50 | 3.20 ± 16.530 |
| Change from Baseline: Day 57 | -5.27 ± 5.154 |
| Change from Baseline: Day 71 | 5.85 ± 19.298 |
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.
| mg/dL | ANX005 |
|---|---|
| Baseline | 9.85 ± 8.704 |
| Change from Baseline: Day 2 End of Infusion | -6.38 ± 8.968 |
| Change from Baseline: Day 4 | 0.00 ± 9.036 |
| Change from Baseline: Day 8 Pre-dose | -0.47 ± 8.214 |
| Change from Baseline: Day 8 End of Infusion | -1.54 ± 9.327 |
| Change from Baseline: Day 15 | 0.52 ± 9.383 |
| Change from Baseline: Day 22 | 0.25 ± 8.993 |
| Change from Baseline: Day 29 | 4.42 ± 7.669 |
| Change from Baseline: Day 36 | -1.16 ± 5.809 |
| Change from Baseline: Day 43 | 1.26 ± 2.740 |
| Change from Baseline: Day 50 | -0.38 ± 1.708 |
| Change from Baseline: Day 57 | -2.00 ± 2.012 |
| Change from Baseline: Day 71 | -0.07 ± 4.507 |
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.
| nanograms/milliliters | ANX005 |
|---|---|
| Baseline | 125906.7 ± 83730.04 |
| Change from Baseline: Day 2 (End of Infusion) | -123406.7 ± 83730.04 |
| Change from Baseline: Day 2 (4 hr after Infusion) | -92144.0 ± 25572.09 |
| Change from Baseline: Day 4 | -120863.3 ± 86782.71 |
| Change from Baseline: Day 8 (Pre-dose) | -114658.3 ± 95534.57 |
| Change from Baseline: Day 8 (End of Infusion) | -139190.0 ± 83036.43 |
| Change from Baseline: Day 8 (4 hr after Infusion) | -139190.0 ± 83036.43 |
| Change from Baseline: Day 15 | -113278.3 ± 97696.09 |
| Change from Baseline: Day 22 | -108186.7 ± 103427.02 |
| Change from Baseline: Day 29 | -73786.0 ± 82530.85 |
| Change from Baseline: Day 36 | -51298.0 ± 43444.46 |
| Change from Baseline: Day 43 | -29952.0 ± 47280.34 |
| Change from Baseline: Day 50 | -4525.0 ± 18893.85 |
| Change from Baseline: Day 57 | 6447.5 ± 34873.98 |
| Change from Baseline: Day 71 | 25240.0 ± 44201.47 |
Collected over Day 1 through Day 71. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ANX005 | 0/7 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| Event | ANX005 |
|---|---|
| Haemolytic anaemiaBlood and lymphatic system disorders | 1/6 |
| Event | ANX005 |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/6 |
| Oedema peripheralGeneral disorders | 2/6 |
| Warm type haemolytic anaemiaBlood and lymphatic system disorders | 1/6 |
| Face oedemaGeneral disorders | 1/6 |
| PyrexiaGeneral disorders | 1/6 |
| RashSkin and subcutaneous tissue disorders | 1/6 |
| Rash erythematousSkin and subcutaneous tissue disorders | 1/6 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/6 |
| DiarrheaGastrointestinal disorders | 1/6 |
| Hypoaesthesia oralGastrointestinal disorders | 1/6 |
Safety Population: all participants who received any amount of ANX005.
| Age, Continuous(years) | ANX005 |
|---|---|
| Mean | 59.0 ± 7.56 |
| Age, Customized(Participants) | ANX005 |
|---|---|
| In utero | 0 |
| Preterm newborn infants (gestational age < 37 wks) | 0 |
| Newborns (0-27 days) | 0 |
| Infants and toddlers (28 days-23 months) | 0 |
| Children (2-11 years) | 0 |
| Adolescents (12-17 years) | 0 |
| Adults (18-64 years) | 5 |
| From 65-84 years | 1 |
| 85 years and over | 0 |
| Sex: Female, Male(Participants) | ANX005 |
|---|---|
| Female | 5 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | ANX005 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ANX005 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2021 to primary completion in Jan 2023, 14 months.
Results were first posted in Jun 2026, 3 years 5 months after primary completion. A results delay was requested in Jan 2024.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tanruprubart
Anemia, Hemolytic, Autoimmune →
Annexon, Inc.