Chronic UrticariaPhase 2CURSIGNCT03436797
A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
A Phase 2 study testing AK002 in people with Chronic Urticaria, run by Allakos Inc. at 4 sites in 2 countries.
Trial summary
This is a Phase 2a, open-label study to assess the effects of AK002 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- AK002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Jan 2018to 6 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 and ≤ 85 years old)
- Body weight <125 Kg
- Informed consent signed and dated
- Able to read, understand, and willing to sign the informed consent form and comply with study procedures
- Diagnosis of CU for at least three months, refractory to antihistamine treatment in single or 4-fold dosage
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures, including willingness to have IV infusion of study drug administered by a qualified person
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- Females of childbearing potential must have a negative pregnancy test at Baseline. Female subjects must be willing to use highly effective contraception (Pearl- 4 Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years (FSH >40mL) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- No participation in other clinical trials 4 weeks before participation in this study
- Uncontrolled CU (UCT <12) at the time of enrollment
Who cannot join
- Acute urticaria
- Concurrent/ongoing treatment with immunosuppressives (e.g., cyclosporine, methotrexate, dapsone, or others) within 4 weeks or 5 half-lives prior to Baseline, whichever is longer
- Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
- History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
- Presence of clinically significant laboratory abnormalities
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- Lactating women or pregnant women
- Substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
- Subjects who are detained officially or legally to an official institute or those that have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities will be excluded from the study
- Use of omalizumab within the last 3 months
- Receipt of intravenous IgG therapy 30 days prior to Baseline
- Plasmapheresis 30 days prior to Baseline
- Use (daily or every other day) of Doxepin 14 days prior to Baseline
- Receipt of inactive vaccination or live attenuated vaccine 30 days prior to Baseline
- Use of H2 antihistamines 7 days before Baseline
- Intake of leukotriene antagonists within 7 days prior to enrollment
- Intake of systemic corticosteroids (e.g., oral or depot) within 14 days prior to enrollment
- Positive screening for ova and parasite test at Baseline
- Treatment of helminthic parasite within 6 months of screening
- Positive HIV serology at screening
- Positive Hepatitis serology at baseline, except for vaccinated patients or patients with past but resolved hepatitis at screening
- Donation or loss of >500ml of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of drug
- Known hypersensitivity to any ingredients of AK002 or drugs related to AK002 (e.g., monoclonal antibodies, polyclonal gamma globulin)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Allakos Investigational Site
Cincinnati, Ohio, 45231
Allakos Investigational Site
Edgewater, Florida, 32132
Germany2 sites
Allakos Investigational Site
Berlin, 10117
Allakos Investigational Site
Mainz, 55131
About this study
Official title: An Open-Label, Pilot Study to Assess the Efficacy and Safety of AK002 (Siglec-8) in Subjects With Antihistamine-Resistant Chronic Urticaria
This is a Phase 2a, open-label study to assess the effects of AK002
Read the detailed description
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.
- Conditions
- Chronic Urticaria
- Being tested
- AK002
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK002Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| AK002-IV | Experimental | AK002 given as monthly intravenous infusions at up to 3 mg/kg. Receives: Drug: AK002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: Baseline to Week 22 (Main Study Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start23 Jan 2018
- Primary completion21 Nov 2018
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Rasmussen, MD, PhD, Study director, Allakos Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436797
- Sponsor's protocol ID
- AK002-006
- Acronym
- CURSIG
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2018
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study to Assess the Efficacy and Safety of AK002 (Siglec-8) in Subjects With Antihistamine-Resistant Chronic Urticaria
- ClinicalTrials.gov ID
- NCT03436797
- Acronym / sponsor ID
- CURSIG / AK002-006
- Conditions
- Chronic Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, open-label study to assess the effects of AK002
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK002-IV | Experimental | Drug: AK002AK002 given as monthly intravenous infusions at up to 3 mg/kg. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (≥ 18 and ≤ 85 years old)
- Body weight <125 Kg
- Informed consent signed and dated
- Able to read, understand, and willing to sign the informed consent form and comply with study procedures
- Diagnosis of CU for at least three months, refractory to antihistamine treatment in single or 4-fold dosage
Key exclusion criteria (23 listed)
- Acute urticaria
- Concurrent/ongoing treatment with immunosuppressives (e.g., cyclosporine, methotrexate, dapsone, or others) within 4 weeks or 5 half-lives prior to Baseline, whichever is longer
- Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
- History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
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 |
|---|---|---|
| AK002AK002 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). | Drug | AK002-IV |
Primary outcome
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase
Time frame: Baseline to Week 22 (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]).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Henrik Rasmussen, MD, PhD study director
Allakos Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK002 in people with Chronic Urticaria, run by Allakos Inc. at 4 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 9 inclusion and 23 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase (time frame: Baseline to Week 22 (Main Study Phase)). 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 4 Mar 2024.