Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

NCT04833855 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20190194
• Study Type: interventional
• Target: 183
• Locations: 10 countries
• Sites: 81

Brief Summary

The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

Conditions

Chronic Spontaneous Urticaria

Keywords

CSU

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 16

  The UAS is a CSU-specific patient-reported outcome measure with 2 components: Hives Severity Score (HSS) for number of wheals and an Itch Severity Score (ISS) for itch intensity, and are each scored from 0 (no wheals, no itch) to 3 (\>50 wheals, severe itch) for the previous 24 hours. The HSS and ISS are combined to give a daily UAS ranging from 0 to 6. The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). The least squares mean (LSM) estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in urticaria activity.

  Baseline and Week 16

Secondary Outcomes (24)

• Change From Baseline in ISS Over 7 Days (ISS7) at Week 16

  Baseline and Week 16

• Change From Baseline in HSS Over 7 Days (HSS7) at Week 16

  Baseline and Week 16

• Number of Participants With a UAS7 of ≤ 6 (Minimal Residual Disease) at Week 16

  Week 16

• Number of Participants With a Change From Baseline in UAS7 of ≤ -10 (Minimal Important Difference)

  Baseline and Week 16

• Number of Participants With a UAS7 = 0 at Week 16 (Complete Response)

  Week 16

Study Arms (7)

Group 1: Omalizumab

ACTIVE COMPARATOR

Participants naive to anti-IgE therapies will receive omalizumab.

Biological: Omalizumab

Group 2: Placebo

PLACEBO COMPARATOR

Participants naive to anti-IgE therapies will receive a placebo.

Biological: Placebo

Group 3: Tezepelumab Dose 1

EXPERIMENTAL

Participants naive to anti-IgE therapies will receive tezepelumab.

Biological: Tezepelumab Dose 1

Group 4: Tezepelumab Dose 2

EXPERIMENTAL

Participants naive to anti-IgE therapies will receive tezepelumab.

Biological: Tezepelumab Dose 2

Group 5: Placebo

PLACEBO COMPARATOR

Participants previously treated with anti-IgE therapies will receive a placebo.

Biological: Placebo

Group 6: Tezepelumab Dose 1

EXPERIMENTAL

Participants previously treated with anti-IgE therapies will receive tezepelumab.

Biological: Tezepelumab Dose 1

Group 7: Tezepelumab Dose 2

EXPERIMENTAL

Participants previously treated with anti-IgE therapies will receive tezepelumab.

Biological: Tezepelumab Dose 2

Interventions

Tezepelumab Dose 1 BIOLOGICAL

Subcutaneous injection.

Also known as: AMG 157

Group 3: Tezepelumab Dose 1; Group 6: Tezepelumab Dose 1

Tezepelumab Dose 2 BIOLOGICAL

Subcutaneous injection.

Also known as: AMG 157

Group 4: Tezepelumab Dose 2; Group 7: Tezepelumab Dose 2

Omalizumab BIOLOGICAL

Subcutaneous injection.

Also known as: Xolair

Group 1: Omalizumab

Placebo BIOLOGICAL

Subcutaneous injection.

Group 2: Placebo; Group 5: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• 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

You may not qualify if:

• Disease related, including but not limited to:
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (81)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Avance Clinical Trials

Laguna Niguel, California, 92677, United States

Location

Jonathan Corren MD Inc

Los Angeles, California, 90025, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Asthma and Allergy Associates PC

Colorado Springs, Colorado, 80907, United States

Location

The Community Research of South Florida

Miami Lakes, Florida, 33016, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, 66210, United States

Location

Bluegrass Allergy Care

Lexington, Kentucky, 40509, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

David Fivenson MD Professional Liability Company

Ann Arbor, Michigan, 48103, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Bernstein Clinical Research Center LLC

Cincinnati, Ohio, 45236, United States

Location

Aventiv Research Inc

Dublin, Ohio, 43016, United States

Location

Clinical Partners LLC

Johnston, Rhode Island, 02919, United States

Location

The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research

Knoxville, Tennessee, 37909, United States

Location

Suzanne Bruce and Associates

Houston, Texas, 77056, United States

Location

Cutis Wellness Dermatology and Dermatopathology, PLLC

Laredo, Texas, 78041, United States

Location

Dermatology Research Institute Incorporated

Calgary, Alberta, T2J 7E1, Canada

Location

Brunswick Dermatology Centre

Fredericton, New Brunswick, E3B 1G9, Canada

Location

LEADER Research

Hamilton, Ontario, L8L 3C3, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

Cheema Research Incorporated

Mississauga, Ontario, L5A 3V4, Canada

Location

Dr. S. K. Siddha Medicine Professional Corporation

Newmarket, Ontario, L3Y 5G8, Canada

Location

Allergy Research Canada Incorporated

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Gordon Sussman Clinical Research Incorporated

North York, Ontario, M3B 3S6, Canada

Location

Clinique Spécialisée en Allergie de la Capitale

Québec, Quebec, G1V 4W2, Canada

Location

Centre Hospitalier Universitaire de Brest - Hôpital Morvan

Brest, 29200, France

Location

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, 38043, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire Archet 2

Nice, 06202, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

*Charité*

Berlin, 12203, Germany

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Johannes Gutenberg Universitaet Mainz

Mainz, 55101, Germany

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

Sotiria General Hospital

Athens, 11527, Greece

Location

Attikon University General Hospital of Athens

Athens, 12462, Greece

Location

Andreas Syggros Hospital

Athens, 16121, Greece

Location

George Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 56403, Greece

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliero Universitaria di Modena

Modena, 41124, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, 00133, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

IRCCS Istituto Clinico Humanitas

Rozzano MI, 20089, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Fujita Health University Bantane Hospital

Nagoya, Aichi-ken, 454-8509, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Takagi Dermatological Clinic

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Kosugi Dermatology Clinic

Kawasaki-shi, Kanagawa, 211-0063, Japan

Location

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

Location

Osaka Habikino Medical Center

Habikino-shi, Osaka, 583-8588, Japan

Location

Dermatology and Ophthalmology Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa

Lodz, 91-495, Poland

Location

SPZOZ Centralny Szpital Kliniczny

Lodz, 92-213, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, 20-081, Poland

Location

Clinical Research Center Spzoo Medic-R Spolka Komandytowa

Poznan, 61-731, Poland

Location

Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina

Rzeszów, 35-055, Poland

Location

Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski

Warsaw, 02-473, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Ajou University Hospital

Suwon-si, Gyeonggi-do, 16499, South Korea

Location

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Arnau de Vilanova de Valencia

Valencia, Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 39956278 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Chronic Urticaria

Interventions

tezepelumab; Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 6, 2021
• Study Start: April 15, 2021
• Primary Completion: December 20, 2022
• Study Completion: April 13, 2023
• Last Updated: April 9, 2025
• Results First Posted: May 1, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CA (9); IT (6); PL (8); FR (5); KR (6); JP (9); ES (5); DE (3); GR (5); US (25)