Chronic Spontaneous UrticariaPhase 2MAVERICKNCT05528861

A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

A Phase 2 study testing Lirentelimab (AK002) in people with Chronic Spontaneous Urticaria, run by Allakos Inc. at 67 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Spontaneous Urticaria
What is being tested?: Lirentelimab (AK002)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 67 sitesin 3 countries
Study dates: 26 Oct 2022to 18 Apr 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
Male and female subjects ≥18 years of age at the time of screening.
CSU diagnosis for ≥6 months.
Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum of the licensed dose at the licensed frequency at the time of randomization as defined by the following: presence of hives and itch for ≥6 consecutive weeks prior to Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during the 7 days prior to randomization.
Subjects that are omalizumab-naïve or omalizumab-exposed.
Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and at the licensed frequency, for treatment of CSU for at least 1 week prior to screening and willing to remain on a stable dose throughout the study.
Able and compliant with completing a daily symptom eDiary for the duration of the study and adherent to the study visit schedules.

Who cannot join

History of hypersensitivity to the study drugs or their excipients or to drugs of similar chemical classes (i.e., murine, chimeric or human antibodies).
Current use of biologics for any indication.
Demonstrated lack of primary response to treatment with a biologic therapy (e.g., omalizumab) for the treatment of CSU.
Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab, pramipexole); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG); (iv) plasmapheresis.
Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.
Use of any of the following treatments within 3 weeks prior to the baseline visit: (i) H2 antihistamines (H2-AH); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids; (iii) regular (daily or every other day) doxepin (oral); (iv) leukotriene receptor antagonists (LTRA) (e.g., montelukast, zafirlukast).

Show all 16Show fewer

H1-AH use at greater than approved doses or greater than local CSU guideline recommended doses after Screening Visit 1.
Previous treatment with biologics: (i) any cell-depleting agents including but not limited to rituximab within 6 months prior to the baseline visit or until lymphocyte count returns to normal, whichever is longer; (ii) other biologics, including investigational biologics (e.g., dupilumab, omalizumab, benralizumab, etc) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.
Planned or anticipated use of any prohibited medication.
Subjects having causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria.
Subjects with known or suspected urticarial vasculitis.
Subjects with known or suspected hereditary angioedema.
Any other skin disease associated with chronic itch, including atopic dermatitis, that in the Investigator's opinion might influence study outcome and subject's interpretation of symptoms caused by CSU.
A helminth parasitic infection diagnosed within 6 months prior to the date that informed consent is obtained and has not been treated with or has failed to respond to standard-of-care therapy.
Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).
Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of study drug administration. This exclusion criterion does not apply to all types and formulations of vaccines (including live attenuated vaccines) currently authorized/approved by FDA or other regulatory authority for the prevention of COVID-19, which may be administered before, during, or after the study. The vaccine should not be administered within 3 days before and within 3 days after the administration of lirentelimab so that any side effects caused by either of the 2 medications can more easily be determined.

Trial locations and contacts

67 sites in 3 countries.

Country

City, postcode or hospital

67 sites in 3 countries

United States51 sites

Allakos Investigational Site 227-034
Ann Arbor, Michigan, 48106
Allakos Investigational Site 227-002
Asheville, North Carolina, 28801
Allakos Investigational Site 227-055
Austin, Texas, 78759
Allakos Investigational Site 227-058
Bakersfield, California, 93301
Allakos Investigational Site 227-019
Baltimore, Maryland, 21224
Allakos Investigational Site 227-024
Birmingham, Alabama, 35209
Allakos Investigational Site 227-045
Boise, Idaho, 83706
Allakos Investigational Site 227-016
Boston, Massachusetts, 02111
Allakos Investigational Site 227-022
Brooklyn, New York, 11203
Allakos Investigational Site 227-013
Cincinnati, Ohio, 45229
Allakos Investigational Site 227-029
Cincinnati, Ohio, 45236
Allakos Investigational Site 227-006
Colorado Springs, Colorado, 80907
Allakos Investigational Site 227-018
Columbus, Georgia, 31904
Allakos Investigational Site 227-043
Columbus, Ohio, 43235
Allakos Investigational Site 227-068
Cullman, Alabama, 35058
Allakos Investigational Site 227-032
Detroit, Michigan, 48202
Allakos Investigational Site 227-073
Dilworth, Minnesota, 56529
Allakos Investigational Site 227-049
El Paso, Texas, 79903
Allakos Investigational Site 227-070
Farmington Hills, Michigan, 48346
Allakos Investigational Site 227-007
Great Neck, New York, 11021
Allakos Investigational Site 227-033
Greenfield, Wisconsin, 53228
Allakos Investigational Site 227-028
Hershey, Pennsylvania, 17033
Allakos Investigational Site 227-036
Jacksonville, Florida, 32256
Allakos Investigational Site 227-051
Lexington, Kentucky, 40509
Allakos Investigational Site 227-026
Los Angeles, California, 90025
Allakos Investigational Site 227-009
Los Angeles, California, 90045
Allakos Investigational Site 227-062
Miami, Florida, 33135
Allakos Investigational Site 227-011
Mission Viejo, California, 92691
Allakos Investigational Site 227-059
Missoula, Montana, 59808
Allakos Investigational Site 227-039
Murray, Utah, 84107
Allakos Investigational Site 227-071
Murray, Utah, 84107
Allakos Investigational Site 227-045
Normal, Illinois, 61761
Allakos Investigational Site 227-066
North Charleston, South Carolina, 29420
Allakos Investigational Site 227-060
Oklahoma City, Oklahoma, 73170
Allakos Investigational Site 227-047
Overland Park, Kansas, 66211
Allakos Investigational Site 227-040
Philadelphia, Pennsylvania, 19103
Allakos Investigational Site 227-014
Phoenix, Arizona, 85021
Allakos Investigational Site 227-074
Plainfield, Indiana, 46168
Allakos Investigational Site 227-027
Portland, Oregon, 97223
Allakos Investigational Site 227-057
River Forest, Illinois, 60305
Allakos Investigational Site 227-052
Rochester, Minnesota, 55905
Allakos Investigational Site 227-021
Santa Monica, California, 90404
Allakos Investigational Site 227-041
Sarasota, Florida, 34239
Allakos Investigational Site 227-023
Scottsdale, Arizona, 85251
Allakos Investigational Site 227-008
St Louis, Missouri, 63141
Allakos Investigational Site 227-067
Tampa, Florida, 33607
Allakos Investigational Site 227-005
Tampa, Florida, 33613
Allakos Investigational Site 227-064
Toledo, Ohio, 43617
Allakos Investigational Site 227-012
Towson, Maryland, 21204
Allakos Investigational Site 227-031
Upland, California, 91786
Allakos Investigational Site 227-063
White Marsh, Maryland, 21162

Other trials in United States

Germany12 sites

Allakos Investigational Site 227-204
Augsburg, 86179
Allakos Investigational Site 227-201
Berlin, 12203
Allakos Investigational Site 227-214
Buxtehude, 21614
Allakos Investigational Site 227-205
Darmstadt, 64297
Allakos Investigational Site 227-209
Erlangen, 91054
Allakos Investigational Site 227-208
Frankfurt, 60590
Allakos Investigational Site 227-207
Langenau, 89129
Allakos Investigational Site 227-203
Leipzig, 04103
Allakos Investigational Site 227-210
Mainz, 55128
Allakos Investigational Site 227-202
Mainz, 55131
Allakos Investigational Site 227-211
Munich, 80802
Allakos Investigational Site 227-206
Osnabrück, 49074

Other trials in Germany

Poland4 sites

Allakos Investigational Site 227-302
Lodz
Allakos Investigational Site 227-304
Lodz
Allakos Investigational Site 227-303
Lublin
Allakos Investigational Site 227-301
Zabrze

Other trials in Poland

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.

Conditions: Chronic Spontaneous Urticaria
Being tested: Lirentelimab (AK002), Placebo
Keywords: Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, Chronic Idiopathic Urticaria, Chronic Autoimmune Urticaria, Idiopathic Chronic Urticaria, Autoimmune Urticaria
Medical subject headings: Chronic Urticaria, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lirentelimab (AK002)Drug
Also called AK002
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
PlaceboOther
Placebo

Study groups in NCT05528861
Study group	Role	What they receive
Lirentelimab (AK002)	Experimental	Subjects in this arm will receive lirentelimab (AK002) administered subcutaneously. Receives: Drug: Lirentelimab (AK002)
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12
The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.
Measured: Baseline to Week 12

Secondary outcomes (3)

Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12
The severity of hives will be recorded by all subjects once daily on a scale of 0 (none) to 3 (> 50 hives). A weekly HSS score (HSS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.
Measured: Baseline to Week 12
Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12
The severity of itching will be recorded by all subjects once daily on a scale of 0 (none) to 3 (severe). A weekly ISS score (ISS7) is derived by adding the average daily scores of the 7 days preceding the visit. Therefore, the possible range of the weekly score is 0 - 21.
Measured: Baseline to Week 12
Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12
The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The possible range of the UAS7 is 0-42.
Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 202218 Apr 2024

First posted6 Sep 2022
Study start26 Oct 2022
Primary completion27 Dec 2023
Study completion18 Apr 2024

Why it stopped: No longer pursuing development

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05528861
Sponsor's protocol ID: AK002-027
Acronym: MAVERICK
Status last verified: Sep 2024
First submitted: 1 Sep 2022
Last updated: 27 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria

All Chronic Spontaneous Urticaria trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria
ClinicalTrials.gov ID: NCT05528861
Acronym / sponsor ID: MAVERICK / AK002-027
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, Chronic Idiopathic Urticaria, Chronic Autoimmune Urticaria, Idiopathic Chronic Urticaria, Autoimmune Urticaria
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: No longer pursuing development
Enrolment: 127 participants (actual)
Lead sponsor: Allakos Inc.Industry (pharma, biotech, devices)
Study start: 26 Oct 2022 (actual)
Primary completion: 27 Dec 2023 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 6 Sep 2022 (actual)
Results: Posted 27 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lirentelimab (AK002)	Experimental	Drug: Lirentelimab (AK002)Subjects in this arm will receive lirentelimab (AK002) administered subcutaneously.
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
Male and female subjects ≥18 years of age at the time of screening.
CSU diagnosis for ≥6 months.
Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum of the licensed dose at the licensed frequency at the time of randomization as defined by the following: presence of hives and itch for ≥6 consecutive weeks prior to Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during the 7 days prior to randomization.
Subjects that are omalizumab-naïve or omalizumab-exposed.

Key exclusion criteria (16 listed)

History of hypersensitivity to the study drugs or their excipients or to drugs of similar chemical classes (i.e., murine, chimeric or human antibodies).
Current use of biologics for any indication.
Demonstrated lack of primary response to treatment with a biologic therapy (e.g., omalizumab) for the treatment of CSU.
Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab, pramipexole); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG); (iv) plasmapheresis.
Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.

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
Lirentelimab (AK002)Also: AK002Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8	Drug	Lirentelimab (AK002)
PlaceboPlacebo	Other	Placebo

Primary outcome

Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12
Time frame: Baseline to Week 12
The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.

3 secondary outcomes

Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12
Time frame: Baseline to Week 12
Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12
Time frame: Baseline to Week 12
Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12
Time frame: At Week 12

Results and safety

Results posted to the registry on 27 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AK002 SC 300 mg (Main Study) - AK002 Continuing (OLE)	66	60
Placebo (Main Study) - Placebo Rollover (OLE)	61	57

Primary outcome: Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	AK002 SC 300 mg (Main Study) n = 64	Placebo (Main Study) n = 59
Value	-7.9 (1.9)	-8.4 (2.0)

AK002 SC 300 mg (Main Study) vs Placebo (Main Study): LSM Difference from Placebo: 0.5 (95% CI -3.6 to 4.5), p = 0.8174, ANCOVA

Population analysed: Modified Intent-to-Treat Population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, up to 34 weeks (open-label extension period). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AK002 SC 300 mg (Main Study)	1 of 66 (1.5%)	26 of 66 (39.4%)	0 of 66
Placebo (Main Study)	1 of 61 (1.6%)	18 of 61 (29.5%)	0 of 61
AK002 Continuing (OLE)	2 of 60 (3.3%)	22 of 60 (36.7%)	0 of 60
Placebo Rollover (OLE)	2 of 57 (3.5%)	19 of 57 (33.3%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Spontaneous Urticaria

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria

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.

Chin Lee, MD, MPH study director

Allakos Inc.

67 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lirentelimab (AK002) in people with Chronic Spontaneous Urticaria, run by Allakos Inc. at 67 sites in 3 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Germany, Poland. 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. Some participants in this study may receive a placebo. 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 27 Sep 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?

Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05528861.

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 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.