A Phase 2 interventional study of AK002 in Chronic Urticaria, sponsored by Allakos Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by Allakos Inc. · Phase 2, Interventional, and Treatment
This is a Phase 2a, open-label study to assess the effects of AK002
This open-label study is to assess the effects of AK002, given as monthly intravenous infusions at up to 3 mg/kg. A total of 47 patients will be enrolled across 2-4 sites. All patients enrolled in the study will receive 6 monthly infusions of AK002 and will then be followed for another 8 weeks. Some patients will have the option to receive an additional 12 months of extended dosing.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 47 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →Allakos Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
AK002 given as monthly intravenous infusions at up to 3 mg/kg.
Drug: AK002
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase
The UCT score consists of 4 items, and each UCT item has 5 answer options (scored with 0-4 points), where low points indicate high disease activity and low disease control of chronic urticaria. The UCT score, ranging from 0 to 16, is calculated by adding all 4 individual item scores. A UCT score of 16 points indicates complete disease control and a change of the UCT score of 3 or more points was regarded as clinically relevant (minimal clinically important difference \[MCID\]).
Time frame: Baseline to Week 22 (Main Study Phase)
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase
Adverse events were assessed during the Extended Dosing Phase of the study, and only the 5 subjects who entered the Extended Dosing Phase were included.
Time frame: Through study completion, up to 52 weeks (Extension Dosing Phase)
47 subjects were enrolled in the main study and received at least one dose of AK002. 45 subjects had at least one post-baseline assessment of the primary efficacy variable and were reported in the baseline period. 5 subjects from the main study were allowed the option to receive extended dosing with up to 12 additional doses of AK002.
| Milestone | AK002 |
|---|---|
| Started | 47 |
| Completed | 37 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 4 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 1 |
| Withdrew: Non-specific | 2 |
| Milestone | AK002 |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Patient decision | 1 |
The UCT score consists of 4 items, and each UCT item has 5 answer options (scored with 0-4 points), where low points indicate high disease activity and low disease control of chronic urticaria. The UCT score, ranging from 0 to 16, is calculated by adding all 4 individual item scores. A UCT score of 16 points indicates complete disease control and a change of the UCT score of 3 or more points was regarded as clinically relevant (minimal clinically important difference \[MCID\]).
| Score on a scale | CholU | UF-Cohort | CSU-XN | CSU-XF |
|---|---|---|---|---|
| Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase | 6.5 ± 6.15 | 3.4 ± 4.09 | 11.1 ± 4.07 | 4.8 ± 6.97 |
Adverse events were assessed during the Extended Dosing Phase of the study, and only the 5 subjects who entered the Extended Dosing Phase were included.
| Participants | AK002 |
|---|---|
| Subjects with ≥1 adverse events | 5 |
| Subjects with ≥1 treatment-related adverse events | 4 |
| Subjects with an adverse event leading to study drug discontinuation | 0 |
| Subjects with ≥1 serious adverse events | 1 |
| Subjects with ≥1 treatment-related serious adverse events | 0 |
Collected over Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AK002 Main Study | 1/47 (2.1%) | 4/47 (8.5%) | 33/47 (70.2%) |
| AK002 Extended Dosing | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Event | AK002 Main Study | AK002 Extended Dosing |
|---|---|---|
| EnchondromatosisNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/47 | 1/5 |
| HypertensionVascular disorders | 1/47 | 0/5 |
| Tendon ruptureInjury, poisoning and procedural complications | 1/47 | 0/5 |
| Cardiac failure acuteCardiac disorders | 1/47 | 0/5 |
| Abdominal pain upperGastrointestinal disorders | 1/47 | 0/5 |
| AppendicitisInfections and infestations | 1/47 | 0/5 |
| Event | AK002 Main Study | AK002 Extended Dosing |
|---|---|---|
| NasopharyngitisInfections and infestations | 10/47 | 4/5 |
| Infusion related reactionInjury, poisoning and procedural complications | 20/47 | 3/5 |
| HeadacheNervous system disorders | 9/47 | 2/5 |
| Oral herpesInfections and infestations | 0/47 | 2/5 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/47 | 1/5 |
| SinusitisInfections and infestations | 3/47 | 1/5 |
| Sinus arrhythmiaCardiac disorders | 1/47 | 1/5 |
| GoitreEndocrine disorders | 0/47 | 1/5 |
| Abdominal painGastrointestinal disorders | 0/47 | 1/5 |
| NauseaGastrointestinal disorders | 0/47 | 1/5 |
47 subjects were enrolled in the main study and received at least one dose of the study drug; 45 of these subjects had at least one post-baseline assessment of the primary efficacy variable and were reported in the baseline period. 5 subjects in the CholU, UF, and CSU-XOLAIR® (omalizumab) failure cohorts of the main study were enrolled in the extended dosing phase.
| Age, Continuous(years) | AK002 |
|---|---|
| Main Study Phase | 42 (18 to 75) |
| Extended Dosing Phase | 43 (24 to 55) |
| Sex: Female, Male(Participants) | AK002 |
|---|---|
| Main Study Phase — Female | 34 |
| Main Study Phase — Male | 11 |
| Extended Dosing Phase — Female | 5 |
| Extended Dosing Phase — Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | AK002 |
|---|---|
| Main Study Phase — Hispanic or Latino | 2 |
| Main Study Phase — Not Hispanic or Latino | 43 |
| Main Study Phase — Unknown or Not Reported | 0 |
| Extended Dosing Phase — Hispanic or Latino | 1 |
| Extended Dosing Phase — Not Hispanic or Latino | 4 |
| Extended Dosing Phase — Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | AK002 |
|---|---|
| Main Study Phase — American Indian or Alaska Native | 0 |
| Main Study Phase — Asian | 0 |
| Main Study Phase — Native Hawaiian or Other Pacific Islander | 0 |
| Main Study Phase — Black or African American | 1 |
| Main Study Phase — White | 44 |
| Main Study Phase — More than one race | 0 |
| Main Study Phase — Unknown or Not Reported | 0 |
| Extended Dosing Phase — American Indian or Alaska Native | 0 |
| Extended Dosing Phase — Asian | 0 |
| Extended Dosing Phase — Native Hawaiian or Other Pacific Islander | 0 |
| Extended Dosing Phase — Black or African American | 0 |
| Extended Dosing Phase — White | 5 |
| Extended Dosing Phase — More than one race | 0 |
| Extended Dosing Phase — Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | AK002 |
|---|---|
| United States | 16 |
| Germany | 29 |
| Urticaria Control Test (UCT) Score(Score on a scale) | AK002 |
|---|---|
| Main Study Phase | 4.4 ± 3.1 |
| Extended Dosing Phase | 1.6 ± 1.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: AK002
Allakos Inc.