Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
NCT ID: NCT04833855
Last Updated: 2025-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2021-04-15
2023-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1: Omalizumab
Participants naive to anti-IgE therapies will receive omalizumab.
Omalizumab
Subcutaneous injection.
Group 2: Placebo
Participants naive to anti-IgE therapies will receive a placebo.
Placebo
Subcutaneous injection.
Group 3: Tezepelumab Dose 1
Participants naive to anti-IgE therapies will receive tezepelumab.
Tezepelumab Dose 1
Subcutaneous injection.
Group 4: Tezepelumab Dose 2
Participants naive to anti-IgE therapies will receive tezepelumab.
Tezepelumab Dose 2
Subcutaneous injection.
Group 5: Placebo
Participants previously treated with anti-IgE therapies will receive a placebo.
Placebo
Subcutaneous injection.
Group 6: Tezepelumab Dose 1
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Tezepelumab Dose 1
Subcutaneous injection.
Group 7: Tezepelumab Dose 2
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Tezepelumab Dose 2
Subcutaneous injection.
Interventions
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Tezepelumab Dose 1
Subcutaneous injection.
Tezepelumab Dose 2
Subcutaneous injection.
Omalizumab
Subcutaneous injection.
Placebo
Subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female participants ≥ 18 years and ≤ 80 years of age at the time of screening.
* Chronic spontaneous urticaria (CSU) diagnosis for ≥ 6 months at the time of screening.
* CSU inadequately controlled by second generation H1-antihistamines (sgAH) at enrollment, as defined by all of the following:
* The presence of itch and hives for \>= 6 consecutive weeks at any time prior to screening visit 2
* Failure to respond to an sgAH (up to 4 times the approved dose)
* Urticaria Activity Score over 7 days (UAS7) (range 0-42) \>= 16 and Hives Severity Score over 7 days (HSS7) (range 0-21) \>= 8 during the 7 days prior to enrollment
* Participant with CSU who discontinued, is intolerant to, or was an inadequate responder to anti-IgE therapies despite being treated with omalizumab 300 mg every 4 weeks (Q4W) for 6 months or higher doses of omalizumab \> 2 months or another anti-IgE therapy. Note: This criterion is only applicable for anti-IgE-experienced participants.
* Participant willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
* Subject must have been on a sgAH at approved or increased doses (up to 4x the approved dose) for treatment of CSU for at least 3 consecutive days immediately prior to the day -14 screening visit (screening visit 2) and must have documented current use on the day of screening visit 1
Exclusion Criteria
* Urticaria is solely due to inducible urticaria
* Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency)
* Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, dermatitis herpetiformis, senile pruritus, etc.)
* History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the participant in the study, interfere with evaluation of the investigational product, or reduce the participants ability to participate in the study.
* Evidence of active tuberculosis (TB) (in the opinion of the investigator), either treated or untreated, or a positive purified protein derivative (PPD) or QuantiFERON-TB Gold Plus (QFT-Plus) test for TB during screening.
* History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening visit 1.
* Subject is unable to complete an electronic patient diary or complete questionnaires, or does not meet the required level of compliance with the eDiary during the 14 days sgAH stabilization period
Other medical conditions
* History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation.
Prior/concomitant therapy, including but not limited to:
* Treatment with any biologic products (eg, omalizumab, ligelizumab) within 4 months or 5 half-lives (whichever is longer) prior to screening visit 1
* Routine (daily or every other day for 5 or more consecutive days) use of systemic corticosteroids, systemic hydroxychloroquine, methotrexate, cyclosporine A, cyclophosphamide, tacrolimus, azathioprine, and mycophenolate mofetil within 30 days prior to screening visit 1.
* Major surgery within 8 weeks prior to screening visit 1 or planned inpatient surgery or hospitalization during the study period.
* Receipt of Ig or blood products within 30 days prior to screening visit 1.
* Vaccination with a live or attenuated vaccine within 30 days prior to screening visit 1. Receipt of COVID-19 vaccines and inactive/killed vaccinations (eg, inactive influenza) are allowed, provided the vaccinations are not administered within 7 days before or after any study dosing visit.
* Known hypersensitivity, including severe hypersensitivity reactions and/or history of anaphylactic shock, to any of the products or components to be administered during dosing or to products of similar chemical classes (ie, to murine, chimeric, or human antibodies.
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
First OC Dermatology
Fountain Valley, California, United States
Avance Clinical Trials
Laguna Niguel, California, United States
Jonathan Corren MD Inc
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Science Institute
Santa Monica, California, United States
Asthma and Allergy Associates PC
Colorado Springs, Colorado, United States
The Community Research of South Florida
Miami Lakes, Florida, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, United States
Bluegrass Allergy Care
Lexington, Kentucky, United States
Family Allergy and Asthma Research Institute
Louisville, Kentucky, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States
David Fivenson MD Professional Liability Company
Ann Arbor, Michigan, United States
Clarkston Skin Research
Clarkston, Michigan, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, United States
Aventiv Research Inc
Dublin, Ohio, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research
Knoxville, Tennessee, United States
Suzanne Bruce and Associates
Houston, Texas, United States
Cutis Wellness Dermatology and Dermatopathology, PLLC
Laredo, Texas, United States
Dermatology Research Institute Incorporated
Calgary, Alberta, Canada
Brunswick Dermatology Centre
Fredericton, New Brunswick, Canada
LEADER Research
Hamilton, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Cheema Research Incorporated
Mississauga, Ontario, Canada
Dr. S. K. Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
Allergy Research Canada Incorporated
Niagara Falls, Ontario, Canada
Gordon Sussman Clinical Research Incorporated
North York, Ontario, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Quebec, Canada
Centre Hospitalier Universitaire de Brest - Hôpital Morvan
Brest, , France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, , France
Hôpital Saint Eloi
Montpellier, , France
Centre Hospitalier Universitaire Archet 2
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
*Charité*
Berlin, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Johannes Gutenberg Universitaet Mainz
Mainz, , Germany
Laiko General Hospital of Athens
Athens, , Greece
Sotiria General Hospital
Athens, , Greece
Attikon University General Hospital of Athens
Athens, , Greece
Andreas Syggros Hospital
Athens, , Greece
George Papageorgiou General Hospital of Thessaloniki
Thessaloniki, , Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero Universitaria di Modena
Modena, , Italy
Fondazione Policlinico Tor Vergata
Roma, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, , Italy
Fujita Health University Bantane Hospital
Nagoya, Aichi-ken, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, Japan
Kosugi Dermatology Clinic
Kawasaki-shi, Kanagawa, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Osaka Habikino Medical Center
Habikino-shi, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa
Lodz, , Poland
SPZOZ Centralny Szpital Kliniczny
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, , Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, , Poland
Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina
Rzeszów, , Poland
Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski
Warsaw, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon-si, Gyeonggi-do, , South Korea
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Valencia, Spain
Countries
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References
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McLaren J, Chon Y, Gorski KS, Bernstein JA, Corren J, Hayama K, Jain V, Lima H, Sofen H, Ponnarambil S, Molfino NA, Maurer M. Tezepelumab for the treatment of chronic spontaneous urticaria: Results of the phase 2b INCEPTION study. J Allergy Clin Immunol. 2025 Jun;155(6):1945-1956. doi: 10.1016/j.jaci.2025.01.045. Epub 2025 Feb 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20190194
Identifier Type: -
Identifier Source: org_study_id
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