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Chronic Spontaneous Urticaria (CSU)Phase 3RECLAIMNCT06868212

A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

A Phase 3 study testing Remibrutinib and Dupilumab in people with Chronic Spontaneous Urticaria (CSU), run by Novartis Pharmaceuticals at 121 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria (CSU)
What is being tested?
Remibrutinib and Dupilumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
409 participants
Where
121 sitesUnited States
Study dates
11 Jul 2025to 17 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Adults ≥ 18 years of age at the time of signing the informed consent
  • CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
  • Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:
  • The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
  • UAS7 score (range, 0-42) ≥ 16, and
  • ISS7 score (range, 0-21) ≥ 6, and
Show all 10Show fewer
  • HSS7 score (range, 0-21) ≥ 6
  • Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history
  • Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol
  • Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)

Who cannot join

  • Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
  • Previous use of dupilumab
  • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
  • Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)
  • History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)
  • Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
  • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants [NOAC])
  • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) > 1.5 at screening

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • McFarland Clinic PC

    Ames, Iowa, 50010

  • ClinSite Inc

    Ann Arbor, Michigan, 48106-0525

  • Arlington Center for Dermatology

    Arlington, Texas, 76011

  • Allergy Partners Of West NC

    Asheville, North Carolina, 28801

  • University of Colorado Hospital - Aurora

    Aurora, Colorado, 80045

  • Orion Clinical Research

    Austin, Texas, 78759

  • Florida Ctr Allergy Asthma Research

    Aventura, Florida, 33180

  • Johns Hopkins U School of Med

    Baltimore, Maryland, 21205

  • Chesapeake Clinical Research Inc

    Baltimore, Maryland, 21236

  • Ochsner Health Center

    Baton Rouge, Louisiana, 70816

  • Bellaire Dermatology Associates

    Bellaire, Texas, 77401

  • Bellingham Asthma Allergy and Immunology

    Bellingham, Washington, 98225

  • Allervie Clinical Research

    Birmingham, Alabama, 35209

  • Cahaba Derm and skin hlth ctr 27

    Birmingham, Alabama, 35244

  • Skin Care Research Inc

    Boca Raton, Florida, 33486

  • Boston Specialists LLC

    Boston, Massachusetts, 02111

  • Equity Medical LLC

    Bowling Green, Kentucky, 42104

  • Derm Institute West Michigan PLLC

    Caledonia, Michigan, 49316

  • UNC DermatologyandSkinCancer Ctr

    Chapel Hill, North Carolina, 27516

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland, 20815

  • NW Uni C and T Sciences Ins

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45231

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado, 80907

  • Colorado ENT and Allergy

    Colorado Springs, Colorado, 80909

  • ENT and Allergy Center of Missouri

    Columbia, Missouri, 65201

  • AllerVie Clin Res Columbus GA

    Columbus, Georgia, 31904

  • CR Services Acquisition US

    Columbus, Ohio, 43213

  • Cleaver Medical Group

    Cumming, Georgia, 30040

  • Reveal Research Institute

    Dallas, Texas, 75230

  • Pharma Research and Amp Consult

    Dallas, Texas, 75231

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Omnicure Clinical Research

    Doral, Florida, 33172

  • Southeast Dermatology Specialists

    Douglasville, Georgia, 30135

  • Western Sky Medical Research

    El Paso, Texas, 79924

  • Deaconess Clin Allerg Res Inst

    Evansville, Indiana, 47715

  • Wright State University

    Fairborn, Ohio, 45324

  • FXM Clinical Research Ft Laud

    Fort Lauderdale, Florida, 33308

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Ctr for Dermatology Clinical Res

    Fremont, California, 95438

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072-2301

  • Tribe Clinical Research LLC

    Greenville, South Carolina, 29601

  • Allergic Disease and Asthma Center

    Greenville, South Carolina, 29607

  • Circuit Clinical Mercer Algy Pulm

    Hamilton, New Jersey, 08619

  • Skin Care Research LLC

    Hollywood, Florida, 33021

  • Center for Clinical Studies

    Houston, Texas, 77030

  • Allergy and Asthma Specialists Group

    Huntington Beach, California, 92647

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508

  • Allergy and Asthma Center of Las Vegas

    Las Vegas, Nevada, 89128

  • Las Vegas Dermatology

    Las Vegas, Nevada, 89144

  • Somnos Clinical Research

    Lincoln, Nebraska, 68510

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Acuro Research Inc

    Little Rock, Arkansas, 72205

  • Allergy Asthma Assoc Monmouth

    Little Silver, New Jersey, 07739

  • Orso Health

    Long Beach, California, 90808

  • Ark Clinical Research

    Long Beach, California, 90815

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Family Allergy And Asthma Rsch Inst

    Louisville, Kentucky, 40215

  • The Allergy Group-Meridian Clinic

    Meridian, Idaho, 83642

  • University of MiamiHealth System

    Miami, Florida, 33125

  • FXM Clinical Res Miami LLC

    Miami, Florida, 33175

  • Miami Dade Medical Research

    Miami, Florida, 33176

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Eminat LLC

    Miramar, Florida, 33027

  • International Clinical Research Tennessee LCC

    Murfreesboro, Tennessee, 37130

  • University Of Utah

    Murray, Utah, 84107

  • One Of A Kind Clinical Research

    Napa, California, 94558

  • Southern IN Clinical Trials

    New Albany, Indiana, 47150

  • Midwest Allergy Sinus Asthma SC

    Normal, Illinois, 61761

  • Charleston ENT and Allergy

    North Charleston, South Carolina, 29406

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, 29420

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162

  • Clinical Res Ctr of S Illinois

    O'Fallon, Illinois, 62269

  • Allergy Partners of New Jersey PC

    Ocean Township, New Jersey, 07712

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Allergy and Asthma Specialist P S C

    Owensboro, Kentucky, 42301

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • AllerVie Health

    Panama, Florida, 32405

  • Peak Dermatology

    Payson, Arizona, 85541

  • Premier Allergy Asthma And Immunology

    Phoenix, Arizona, 85032

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Empire Clinical Research

    Pomona, California, 91767

  • Oregon Medical Research Center

    Portland, Oregon, 97223

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Allergy and Asthma Consultants

    Redwood City, California, 94063

  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois, 60305

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Norcal Clinical Research

    Rocklin, California, 95765

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Integrative Skin Science and Res

    Sacramento, California, 95815

  • UC Davis Neuromuscular Research Center

    Sacramento, California, 95817

  • RFSA Dermatology

    San Antonio, Texas, 78213

  • Andante Research

    San Antonio, Texas, 78229

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • Allergy Associates of Utah

    Sandy City, Utah, 84093

  • Dermatology Institute and Skin Care

    Santa Monica, California, 90403

  • Sarasota Clinical Research

    Sarasota, Florida, 34233

  • Aeroallergy Research Laboratories

    Savannah, Georgia, 31406

  • Orso Health

    Scottsdale, Arizona, 85254

  • Endeavor Health Clinical Trials Center

    Skokie, Illinois, 60077

  • The Clinical Research Center

    St Louis, Missouri, 63141

  • Washington University

    St Louis, Missouri, 63141

  • Lenus Research and Med Group LLC

    Sweetwater, Florida, 33172

  • Asthma Allergy Immunology Clin Res

    Tampa, Florida, 33613

  • Equity Medical

    The Bronx, New York, 10455

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • Revival Research Institute

    Troy, Michigan, 48084

  • Somerset Skin Centre

    Troy, Michigan, 48084

  • Vital Prospects Clinical Research Institute

    Tulsa, Oklahoma, 74136

  • Integrated Research of Inland Inc

    Upland, California, 91786

  • Forefront Dermatology

    Vienna, Virginia, 22182

  • Allergy and Asthma Clin Res Inc

    Walnut Creek, California, 94598

  • Howard University Hospital Division of Geriatrics

    Washington D.C., District of Columbia, 20059

  • Accellacare Duly Health and Care

    Wheaton, Illinois, 60189

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Read the detailed description

This study consists of a screening period (up to 4 weeks), a core treatment period (12 weeks double-blind, double-dummy), an optional open-label extension [OLE] period, and safety follow-up period.

Screening period: participants will have a screening period of a minimum of 7 days up to a maximum of 28 days to establish eligibility for the study. Participants meeting all the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

Core treatment period (double-blind, double-dummy): approximately, 400 participants diagnosed with CSU inadequately controlled by sgH1-AH will be randomized in this study. Participants will be stratified based on prior exposure to anti-IgE biologics.

Eligible participants will be randomized in a 1:1 ratio to receive remibrutinib and placebo solution for injection or dupilumab and remibrutinib matching placebo, both as an add-on treatment to once daily standard label dose of sgH1-AH background therapy, until the Week 12 visit.

Additionally, all participants will be on a stable, standard label dose of a sgH1-AH ("background therapy") throughout the entire core treatment period (starting a minimum of 7 days prior to randomization until the end of Week 12). To treat unbearable symptoms of CSU, participants will be allowed to add more of the same sgH1-AH on an as-needed basis ("rescue therapy"). The total maximum daily dose of sgH1-AH (background plus rescue) should not exceed 4 tablets/day (4-fold the standard label dose).

Optional open-label extension [OLE] period: At the end of the 12-week double-blind treatment period, and in case remibrutinib is not commercially available, participants from both arms will be given the choice to roll over into an optional OLE safety period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).

Safety follow-up period:

  • For participants who do not enter the OLE period: there will be a safety follow-up for 12 weeks with safety follow-up phone calls at Week 16 and Week 24 (Week 24 will be end of study).
  • For participants who enter the OLE period: there will be 2 options at the end of Week 24:
  • If remibrutinib is commercially available: participants will discontinue study treatment, perform their EOT visit and receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
  • If remibrutinib is not commercially available, participants may continue on remibrutinib 25 mg b.i.d. until its commercial availability and return for site visits for safety follow up and treatment dispensation every 3 months. When remibrutinib becomes commercially available, the participant will be contacted for a site visit to complete the EOT visit and will receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
Being tested
Remibrutinib, Remibrutinib matching placebo, Dupilumab, Placebo solution for injection
Keywords
BTK inhibitor, chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score
Medical subject headings
Chronic Urticaria

What participants receive

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

  • RemibrutinibDrug

    Film-coated tablet, oral administration, 25 mg b.i.d.

  • Remibrutinib matching placeboDrug

    Film-coated tablet, oral administration, b.i.d.

  • DupilumabDrug

    Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks

  • Placebo solution for injectionDrug

    Solution for injection in pre-filled syringe every 2 weeks

Study groups in NCT06868212
Study groupRoleWhat they receive
Treatment group 1: Remibrutinib + PlaceboExperimentalRemibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week [Weeks 2-10])
Receives: Drug: Remibrutinib; Drug: Placebo solution for injection
Treatment group 2: Dupilumab + remibrutinib matching placeboActive comparatorDupilumab pre-filled syringe (600 mg loading dose [2 x 300 mg dupilumab s.c. injection] at baseline visit followed by dupilumab 300 mg s.c. injection every other week [Weeks 2-10]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)
Receives: Drug: Remibrutinib matching placebo; Drug: Dupilumab

What is being measured

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

  1. Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4

    The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.

    Measured: Baseline, Week 4

Secondary outcomes (6)

  1. Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4

    The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.

    Measured: Baseline, Week 4

  2. Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 4

    The severity of the itch will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.

    Measured: Baseline, Week 4

  3. Improvement of UAS7, assessed as absolute change from baseline in UAS7 score at Week 1

    The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.

    Measured: Baseline, Week 1

  4. Percentage of participants with UAS7 ≤ 6 at Week 4

    Percentage of participants who achieved UAS7 ≤ 6 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.

    Measured: Week 4

  5. Percentage of participants with UAS7=0 at Week 4

    Percentage of participants who achieved UAS7 = 0 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.

    Measured: Week 4

  6. Percentage of participants with UAS7 ≤ 6 at Week 2

    Percentage of participants who achieved UAS7 ≤ 6 at Week 2. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.

    Measured: Week 2

Timeline

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

  1. First posted10 Mar 2025
  2. Study start11 Jul 2025
  3. Primary completion22 Feb 2027 (estimated)
  4. Study completion17 May 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be stratified based on prior exposure to anti-IgE biologics. Eligible participants will be randomized in a 1:1 ratio to receive remibrutinib or dupilumab and remibrutinib matching placebo or placebo solution for injection, both as an add-on treatment to once daily standard label dose of sgH1-AH background therapy, until the Week 12 visit. At the end of the 12-week double-blind treatment period, and in case remibrutinib is not commercially available, participants from both arms will be given the choice to roll over into an optional open label extension (OLE) period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868212
Sponsor's protocol ID
CLOU064AUS02
Acronym
RECLAIM
Status last verified
Oct 2026
First submitted
6 Mar 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Yosipovitch G, Mosnaim G, Ortmann CE, Griswold N, Mast J, Martzloff ED, Rodrigues J, Hawkes JE. Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM). Dermatol Ther (Heidelb). 2026 May;16(5):2575-2585. doi: 10.1007/s13555-026-01716-y. Epub 2026 Mar 19.

    PubMed 41854973

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remibrutinib and Dupilumab in people with Chronic Spontaneous Urticaria (CSU), run by Novartis Pharmaceuticals at 121 sites in United States.

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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (time frame: Baseline, Week 4). 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 NCT06868212, which also lists 1 linked publication.

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 13 Oct 2026.

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