Chronic Spontaneous UrticariaPhase 1NCT06577116
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
A Phase 1 study testing AK006 IV in people with Chronic Spontaneous Urticaria, run by Allakos Inc. at 14 sites in 2 countries.
Trial summary
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- AK006 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 28 Aug 2024to 21 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
- Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
- Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
- Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with <1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States9 sites
Site 601-014
Bakersfield, California, 93301
Site 601-004
Birmingham, Alabama, 35209
Site 601-002
Cincinnati, Ohio, 45236
Site 601-010
El Paso, Texas, 79912
Site 601-013
Greenfield, Wisconsin, 53228
Site 601-019
Lexington, Kentucky, 40509
Site 601-006
Overland Park, Kansas, 66211
Site 601-011
St Louis, Missouri, 63141
Site 601-015
Upland, California, 91786
Canada5 sites
Site 601-106
Calgary, Alberta, T2M 1A6
Site 601-107
Niagara Falls, Ontario, L2H 1H5
Site 601-102
Québec, Quebec, G1V 4W2
Site 601-105
Québec, Quebec, G1W 4R4
Site 601-108
Toronto, Ontario, M5G 1E2
About this study
Official title: An Open-Label Extension Study Evaluating the Safety, Tolerability, PK, Immunogenicity, and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- AK006 IV
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK006 IVDrug
Formulation for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 720mg of AK006 IV | Experimental | Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks. Receives: Drug: AK006 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
Measured: Through study completion, approximately 30 weeks
Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
Measured: Through study completion, approximately 30 weeks
Secondary outcomes (2)
AK006 serum concentrations
Measured: Through study completion, approximately 30 weeks
AK006 Anti-drug Antibodies (ADAs)
Number of participants with positive or negative AK006-ADAs.
Measured: Through study completion, approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start28 Aug 2024
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577116
- Sponsor's protocol ID
- AK006-001X
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study Evaluating the Safety, Tolerability, PK, Immunogenicity, and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
- ClinicalTrials.gov ID
- NCT06577116
- Acronym / sponsor ID
- AK006-001X
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 720mg of AK006 IV | Experimental | Drug: AK006 IVSubjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
- Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
- Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
- Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with <1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.
Key exclusion criteria (2 listed)
- Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK006 IVFormulation for intravenous infusion | Drug | 720mg of AK006 IV |
Primary outcome
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
Time frame: Through study completion, approximately 30 weeks
Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Through study completion, approximately 30 weeks
2 secondary outcomes
AK006 serum concentrations
Time frame: Through study completion, approximately 30 weeks
AK006 Anti-drug Antibodies (ADAs)
Time frame: Through study completion, approximately 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK006 IV in people with Chronic Spontaneous Urticaria, run by Allakos Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation (time frame: Through study completion, approximately 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.