Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (INCEPTION)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria

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

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Biological: Omalizumab; Biological: Placebo; Biological: Tezepelumab Dose 1; Biological: Tezepelumab Dose 2

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4W2
    • Clinique Spécialisée en Allergie de la Capitale
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Incorporated
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Brunswick Dermatology Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 3C3
      • LEADER research
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Mississauga, Ontario, Canada, L5A 3V4
      • Cheema Research Incorporated
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S. K. Siddha Medicine Professional Corporation
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Allergy Research Canada Incorporated
    • North York, Ontario, Canada, M3B 3S6
      • Gordon Sussman Clinical Research Incorporated
• France
  • Brest, France, 29200
    • Centre Hospitalier Universitaire de Brest - Hôpital Morvan
  • Grenoble Cedex 9, France, 38043
    • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
  • Montpellier cedex 5, France, 34295
    • Hopital Saint Eloi
  • Nice, France, 06202
    • Centre Hospitalier Universitaire Archet 2
  • Pierre Benite Cedex, France, 69495
    • Centre hospitalier Lyon Sud
• Germany
  • Berlin, Germany, 12203
    • *Charité*
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Mainz, Germany, 55101
    • Johannes Gutenberg Universitaet Mainz
• Greece
  • Athens, Greece, 11527
    • Sotiria General Hospital
  • Athens, Greece, 11527
    • Laiko General Hospital of Athens
  • Athens, Greece, 12462
    • Attikon University General Hospital of Athens
  • Athens, Greece, 16121
    • Andreas Syggros Hospital
  • Thessaloniki, Greece, 56403
    • George Papageorgiou General Hospital of Thessaloniki
• Italy
  • Milano, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Modena, Italy, 41124
    • Azienda Ospedaliero Universitaria di Modena
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00133
    • Fondazione Policlinico Tor Vergata
  • Rozzano MI, Italy, 20089
    • Irccs Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 454-8509
      • Fujita Health University Bantane Hospital
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-0063
      • Kosugi Dermatology Clinic
    • Yokohama-shi, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic
  • Osaka
    • Habikino-shi, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Sakai-shi, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo
• Korea, Republic of
  • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
    • Hallym University Dongtan Sacred Heart Hospital
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Hospital
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Lodz, Poland, 91-495
    • AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa
  • Lodz, Poland, 92-213
    • SPZOZ Centralny Szpital Kliniczny
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Poznan, Poland, 61-731
    • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  • Rzeszow, Poland, 35-055
    • Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny
  • Warszawa, Poland, 02-473
    • Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski
• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08003
      • Hospital del Mar
    • Barcelona, Cataluña, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
    • Hospitalet de LLobregat, Cataluña, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Hospital General Universitario de Valencia
    • Valencia, Comunidad Valenciana, Spain, 46015
      • Hospital Arnau de Vilanova de Valencia
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • California
    • Fountain Valley, California, United States, 92708
      • First Oc Dermatology
    • Laguna Niguel, California, United States, 92677
      • Avance Clinical Trials
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90025
      • Jonathan Corren MD Inc
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates PC
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • The Community Research of South Florida
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research Pc
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Allergy Care
    • Louisville, Kentucky, United States, 40215
      • Family Allergy and Asthma Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Asthma and Allergy Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson MD Professional Liability Company
    • Clarkston, Michigan, United States, 48346
      • Clarkston Skin Research
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center - New Center One
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center LLC
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Inc
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research
  • Texas
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates
    • Laredo, Texas, United States, 78041
      • Cutis Wellness Dermatology and Dermatopathology, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Omalizumab; Participants naive to anti-IgE therapies will receive omalizumab.	Biological: Omalizumab; Subcutaneous injection.; Other Names: Xolair
Placebo Comparator: Group 2: Placebo; Participants naive to anti-IgE therapies will receive a placebo.	Biological: Placebo; Subcutaneous injection.
Experimental: Group 3: Tezepelumab Dose 1; Participants naive to anti-IgE therapies will receive tezepelumab.	Biological: Tezepelumab Dose 1; Subcutaneous injection.; Other Names: AMG 157
Experimental: Group 4: Tezepelumab Dose 2; Participants naive to anti-IgE therapies will receive tezepelumab.	Biological: Tezepelumab Dose 2; Subcutaneous injection.; Other Names: AMG 157
Placebo Comparator: Group 5: Placebo; Participants previously treated with anti-IgE therapies will receive a placebo.	Biological: Placebo; Subcutaneous injection.
Experimental: Group 6: Tezepelumab Dose 1; Participants previously treated with anti-IgE therapies will receive tezepelumab.	Biological: Tezepelumab Dose 1; Subcutaneous injection.; Other Names: AMG 157
Experimental: Group 7: Tezepelumab Dose 2; Participants previously treated with anti-IgE therapies will receive tezepelumab.	Biological: Tezepelumab Dose 2; Subcutaneous injection.; Other Names: AMG 157

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in ISS Over 7 Days (ISS7) at Week 16	The ISS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed itch intensity, with daily scores ranging from 0 (no itch) to 3 (severe itch) for the previous 24 hours. The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline ISS7, 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
Change From Baseline in HSS Over 7 Days (HSS7) at Week 16	The HSS is a component of the UAS, a CSU-specific patient-reported outcome measure and assessed the number of wheals, with daily scores ranging from 0 (no wheals) to 3 (>50 wheals) for the previous 24 hours. The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline HSS7, 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
Number of Participants With a UAS7 of ≤ 6 (Minimal Residual Disease) at Week 16	The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal residual disease in UAS7 was defined as a score ≤ 6 and indicates well-controlled urticaria and a good response to treatment.	Week 16
Number of Participants With a Change From Baseline in UAS7 of ≤ -10 (Minimal Important Difference)	The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). Minimal important difference in UAS7 was defined as a change from baseline of ≤ -10.	Baseline and Week 16
Number of Participants With a UAS7 = 0 at Week 16 (Complete Response)	The sum of the daily UAS over a 7-day period provides the UAS7, from 0 (no symptoms) to 42 (severe urticaria). A complete response was defined as UAS7 = 0 at Week 16.	Week 16
Number of Participants With ISS7 = 0 at Week 16 (Complete Resolution)	The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). An ISS7 = 0 indicates a complete resolution of itch.	Week 16
Number of Participants With a Change From Baseline in ISS7 of ≤ -5 (Minimal Important Difference)	The sum of daily ISS over a 7-day period provides the ISS7, from 0 (no symptoms) to 21 (severe itch). Minimal important difference in ISS7 was defined as a change from baseline of ≤ -5.	Baseline and Week 16
Number of Participants With HSS7 = 0 at Week 16 (Complete Resolution)	The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). An HSS7 = 0 indicates a complete resolution of hives.	Week 16
Number of Participants With a Change From Baseline in HSS7 of ≤ -5.5 (Minimal Important Difference)	The sum of daily HSS over a 7-day period provides the HSS7, from 0 (no symptoms) to 21 (severe wheals). Minimal important difference in HSS7 was defined as a change from baseline of ≤ -5.5.	Baseline and Week 16
Change From Baseline in Weekly Sleep Interference Score (SIS7) at Week 16	The SIS is part of the Urticaria Patient Daily Diary and was assessed by the participant using the electronic diary once daily in the morning. Participants scored sleep interference on a scale of 0 (no interference) to 3 (substantial, woke up often, severe interference with sleep). The SIS7 was a sum of the daily scores over 7 days ranging from 0 to 21. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SIS7, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep interference.	Baseline and Week 16
Change From Baseline in Weekly Sleep Quality Score (SQS7): Sum of Daily SQS at Week 16	The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of the 3 daily sleep quality items over 7 days, ranged from 0 (good quality sleep) to 63 (poor quality sleep). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of SQS, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality.	Baseline and Week 16
Change From Baseline in SQS7: Sum of Average Daily Q1 - Q3 at Week 16	The SQS was assessed by the participant through 3 questions relating to falling asleep (Q1), wakefulness (Q2), and feeling rested in the morning (Q3). The sum of average daily Q1 - Q3 score was generated by averaging 3 daily sleep quality items and then summing the daily average over 7 days with a score ranging from 0 (good quality sleep) to 21 (poor quality sleep) (sum of the average daily Q1 - Q3). The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline SQS7 - sum of average daily Q1 - Q3, treatment, study week and the interaction between treatment and study week. A negative change from baseline indicates an improvement in sleep quality.	Baseline and Week 16
Change From Baseline in Urticaria Control Test (UCT) Score at Week 16	The UCT assesses disease control in participants with CSU through a retrospective validated scoring system, evaluating the physical symptoms of chronic urticaria (itch, hives and/or angioedema) and the effectiveness of treatment over 4 weeks. It consists of 4 questions with 5 answer options, scored from 0 to 4, and the UCT score is the sum of all 4 questions, with total score ranging from 0 (no control) to 16 (complete control). A score of ≥ 12 indicates well-controlled urticaria and a score of ≤ 11 points indicates poor disease control. A positive change from baseline indicates an improvement in disease control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline UCT score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Change From Baseline in Weekly Angioedema Activity Score (AAS7) at Week 16	The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Negative changes from baseline indicate an improvement in angioedema activity. The LSM estimates were based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AAS7, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Number of Cumulative Weeks That Participants Achieved AAS7 = 0 at Week 16 (Angioedema Occurrence Free)	The AAS is a 5-item patient-reported outcome measure used to determine angioedema activity. Participants retrospectively documented the presence or absence of angioedema in the past 24 hours, and the AAS daily score ranged from 0 to 15 points, assessing 5 key factors when angioedema is present, including duration, physical discomfort, impact on daily activities, impact on appearance, and overall severity). The daily AAS scores are summed for 7 days to form the AAS7 with a range of 0 (not present) to 105 (most severe angioedema activity). Angioedema occurrence free was defined as AAS7 = 0.	Baseline to Week 16
Change From Baseline in the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at Week 16	The CU-Q2oL is a 23-item, self-reported urticaria-specific measure to evaluate 6 dimensions of quality of life (QoL): pruritus, impact on life activities, sleep problems, limitations, looks, and swelling. The total score is transformed to a linear scale of 0 to 100 with a higher CU-Q2oL score indicating a higher QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline CU-Q2oL score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a 10-item, participant-completed, health-related QoL assessment with content specific to those with dermatology conditions. The DLQI evaluates participant perceptions including dermatology-related symptoms and feelings, impacts on daily activities, leisure, work or school, personal relationships, and side effects of treatment. The recall period was 1 week. The DLQI total score ranges from 0 to 30 with a higher score indicating a greater QoL impairment. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline DLQI score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Change From Baseline in the Angioedema Quality of Life Questionnaire (AE-QoL) at Week 16	The AE-QoL is a validated angioedema QoL questionnaire for participants with angioedema. It consists of 17 questions evaluating 4 domains including functioning, fatigue/mood, fear/shame, and food with a recall period of 4 weeks. The total score is transformed to a linear scale ranging from 0 to 100, with a higher score indicating a worse impairment in QoL. A negative change from baseline indicates an improvement in QoL. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AE-QoL score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Change From Baseline in the Angioedema Control Test (AECT) Score at Week 16	The AECT is a patient-reported outcome measure to evaluate disease control in the domains of signs and symptoms, QoL, anxiety/fear, and effectiveness of therapy. The total AECT score ranges from 0 to 16, with higher scores indicating well-controlled disease. A positive change from baseline indicates an improvement in angioedema control. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline AECT score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Number of Participants With an AECT Score = 16 at Week 16 (Complete Control)	The total AECT score ranges from 0 to 16, with higher scores indicating better controlled disease. Complete control was defined as AECT score = 16.	Baseline and Week 16
Change From Baseline in the Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score at Week 16	The WPAI-CU is a questionnaire that assesses the impact of an intervention on work productivity, evaluating 4 areas including absenteeism, presenteeism, work productivity loss, and activity impairment over the past 7 days. Each of the areas is scored separately as a percentage, ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. A negative change from baseline indicates an improvement. The LSM estimates are based on the repeated measure model with stratification factor (prior anti-IgE status), baseline WPAI-CU score, treatment, study week and the interaction between treatment and study week.	Baseline and Week 16
Number of Cumulative Days of sgAH Rescue Medication Use From Baseline to Week 16	Participants recorded any need of sgAH rescue medication in their daily electronic diary.	Baseline to Week 16
Serum Concentration of Tezepelumab	The lower limit of quantification was 10 ng/mL, and values below this limit were set to zero.	Week 1 pre-dose, Weeks 2, 4, 8, 12, 16, 24, and 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. TEAEs were AEs that started on or after the first dose of investigational product up to the end of study (Week 32). A serious AE (SAE) was defined as any untoward medical occurrence that met at least 1 of the following serious criteria: immediately life-threatening, required hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or other medically important serious event.	Day 1 Week 1 to Week 32, up to 32 weeks

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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 Feb 14:S0091-6749(25)00172-1. doi: 10.1016/j.jaci.2025.01.045. Online ahead of print.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: CSU
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Urticaria; Urticaria; Immunologic Factors; Physiological Effects of Drugs; Respiratory System Agents; Anti-Asthmatic Agents; Anti-Allergic Agents; Omalizumab; Antibodies, Monoclonal
• Other Study ID Numbers: 20190194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No