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

Primary Purpose

Chronic Spontaneous Urticaria

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tezepelumab Dose 1
Tezepelumab Dose 2
Omalizumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Center of Alabama
  • First OC Dermatology
  • Avance Clinical Trials
  • Jonathan Corren MD Inc
  • Dermatology Research Associates
  • Clinical Science Institute
  • Asthma and Allergy Associates PC
  • The Community Research of South Florida
  • Advanced Medical Research PC
  • Dawes Fretzin Clinical Research Group, LLC
  • Epiphany Dermatology of Kansas, LLC
  • Bluegrass Allergy Care
  • Family Allergy and Asthma Research Institute
  • Johns Hopkins Asthma and Allergy Center
  • David Fivenson MD Professional Liability Company
  • Clarkston Skin Research
  • Henry Ford Medical Center - New Center One
  • Washington University School of Medicine
  • Icahn School of Medicine at Mount Sinai
  • Bernstein Clinical Research Center LLC
  • Aventiv Research Inc
  • Clinical Partners LLC
  • The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research
  • Suzanne Bruce and Associates
  • Cutis Wellness Dermatology and Dermatopathology, PLLC
  • Dermatology Research Institute Incorporated
  • Brunswick Dermatology Centre
  • LEADER Research
  • Lynderm Research Inc
  • Cheema Research Incorporated
  • Dr. S. K. Siddha Medicine Professional Corporation
  • Allergy Research Canada Incorporated
  • Gordon Sussman Clinical Research Incorporated
  • Clinique Spécialisée en Allergie de la Capitale
  • Centre Hospitalier Universitaire de Brest - Hôpital Morvan
  • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
  • Hôpital Saint Eloi
  • Centre Hospitalier Universitaire Archet 2
  • Centre Hospitalier Lyon Sud
  • *Charité*
  • Universitaetsklinikum Dresden
  • Johannes Gutenberg Universitaet Mainz
  • Laiko General Hospital of Athens
  • Sotiria General Hospital
  • Attikon University General Hospital of Athens
  • Andreas Syggros Hospital
  • George Papageorgiou General Hospital of Thessaloniki
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliero Universitaria di Modena
  • Fondazione Policlinico Tor Vergata
  • Policlinico Universitario Agostino Gemelli
  • IRCCS Istituto Clinico Humanitas
  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Fujita Health University Bantane Hospital
  • Hiroshima University Hospital
  • Takagi Dermatological Clinic
  • Kosugi Dermatology Clinic
  • Nomura Dermatology Clinic
  • Osaka Habikino Medical Center
  • Dermatology and Ophthalmology Kume Clinic
  • Nihon University Itabashi Hospital
  • NTT Medical Center Tokyo
  • Hallym University Dongtan Sacred Heart Hospital
  • Seoul National University Bundang Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Hallym University Kangnam Sacred Heart Hospital
  • Ajou University Hospital
  • Uniwersyteckie Centrum Kliniczne
  • AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa
  • SPZOZ Centralny Szpital Kliniczny
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  • Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina
  • Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski
  • Wojskowy Instytut Medyczny
  • Hospital del Mar
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari de Bellvitge
  • Hospital General Universitario de Valencia
  • Hospital Arnau de Vilanova de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1: Omalizumab

Group 2: Placebo

Group 3: Tezepelumab Dose 1

Group 4: Tezepelumab Dose 2

Group 5: Placebo

Group 6: Tezepelumab Dose 1

Group 7: Tezepelumab Dose 2

Arm Description

Participants naive to anti-IgE therapies will receive omalizumab.

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

Participants naive to anti-IgE therapies will receive tezepelumab.

Participants naive to anti-IgE therapies will receive tezepelumab.

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

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

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

Outcomes

Primary Outcome Measures

Change from Baseline in Urticaria Activity Score over 7 days (UAS7)

Secondary Outcome Measures

Number of Participants with a Complete Response in Urticaria Activity Score over 7 Days (UAS7)
Complete response is defined as having a UAS7 score of 0 at week 16.
Change from Baseline in Itch Severity Score over 7 Days (ISS7)
Change from Baseline in Hives Severity Score over 7 Days (HSS7)
Number of Participants with a Urticaria Activity Score over 7 days (UAS7) Score of 6 or Below
Number of Participants with a Change from Baseline in Urticaria Activity Score over 7 days (UAS7) of ≤ -10
Number of Participants with a Complete Resolution of Itch using the Itch Severity Score over 7 Days (ISS7)
Complete resolution of itch is defined as having a ISS7 score of 0 at week 16.
Number of Participants with a Change from Baseline in Itch Severity Score over 7 days (ISS7) of ≤ -5
Number of Participants with a Complete Resolution of Hives using the Hives Severity Score over 7 Days (HSS7)
Complete resolution of hives is defined as a HSS7 score of 0 at week 16.
Number of Participants with a Change from Baseline in Hives Severity Score over 7 Days (HSS7) of ≤ -5.5
Change from Baseline in Sleep Interference Score
Change from Baseline in Sleep Quality Diary Items
Change from Baseline in Urticaria Control Test (UCT) Score
Change from Baseline in Angioedema Activity Score over 7 Days (AAS7)
Number of Cumulative Weeks that Participants are Angioedema Occurrence-free using the Angioedema Activity Score over 7 Days (AAS7)
Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Score
Change from Baseline in Dermatology Life Quality Index (DLQI) Score
Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score
Change from Baseline in Angioedema Control Test (AECT) Score
Number of Participants with Complete Control in Angioedema Control Test (AECT)
Complete control is defined as having an AECT score of 16 at week 16.
Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score
Total Number of H1-antihistamine Rescue Medication Uses
Maximum Observed Concentration of Tezepelumab in Serum (Cmax)
Number of Participants who Experience an Adverse Event (AE)
Number of Participants who Experience a Serious Adverse Event (SAE)

Full Information

First Posted
April 5, 2021
Last Updated
September 8, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04833855
Brief Title
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
Acronym
INCEPTION
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
CSU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Omalizumab
Arm Type
Active Comparator
Arm Description
Participants naive to anti-IgE therapies will receive omalizumab.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants naive to anti-IgE therapies will receive a placebo.
Arm Title
Group 3: Tezepelumab Dose 1
Arm Type
Experimental
Arm Description
Participants naive to anti-IgE therapies will receive tezepelumab.
Arm Title
Group 4: Tezepelumab Dose 2
Arm Type
Experimental
Arm Description
Participants naive to anti-IgE therapies will receive tezepelumab.
Arm Title
Group 5: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants previously treated with anti-IgE therapies will receive a placebo.
Arm Title
Group 6: Tezepelumab Dose 1
Arm Type
Experimental
Arm Description
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Arm Title
Group 7: Tezepelumab Dose 2
Arm Type
Experimental
Arm Description
Participants previously treated with anti-IgE therapies will receive tezepelumab.
Intervention Type
Biological
Intervention Name(s)
Tezepelumab Dose 1
Other Intervention Name(s)
AMG 157
Intervention Description
Subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Tezepelumab Dose 2
Other Intervention Name(s)
AMG 157
Intervention Description
Subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection.
Primary Outcome Measure Information:
Title
Change from Baseline in Urticaria Activity Score over 7 days (UAS7)
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Number of Participants with a Complete Response in Urticaria Activity Score over 7 Days (UAS7)
Description
Complete response is defined as having a UAS7 score of 0 at week 16.
Time Frame
Week 16
Title
Change from Baseline in Itch Severity Score over 7 Days (ISS7)
Time Frame
Baseline to Week 16
Title
Change from Baseline in Hives Severity Score over 7 Days (HSS7)
Time Frame
Baseline to Week 16
Title
Number of Participants with a Urticaria Activity Score over 7 days (UAS7) Score of 6 or Below
Time Frame
Week 16
Title
Number of Participants with a Change from Baseline in Urticaria Activity Score over 7 days (UAS7) of ≤ -10
Time Frame
Baseline to Week 16
Title
Number of Participants with a Complete Resolution of Itch using the Itch Severity Score over 7 Days (ISS7)
Description
Complete resolution of itch is defined as having a ISS7 score of 0 at week 16.
Time Frame
Week 16
Title
Number of Participants with a Change from Baseline in Itch Severity Score over 7 days (ISS7) of ≤ -5
Time Frame
Baseline to Week 16
Title
Number of Participants with a Complete Resolution of Hives using the Hives Severity Score over 7 Days (HSS7)
Description
Complete resolution of hives is defined as a HSS7 score of 0 at week 16.
Time Frame
Week 16
Title
Number of Participants with a Change from Baseline in Hives Severity Score over 7 Days (HSS7) of ≤ -5.5
Time Frame
Baseline to Week 16
Title
Change from Baseline in Sleep Interference Score
Time Frame
Baseline to Week 16
Title
Change from Baseline in Sleep Quality Diary Items
Time Frame
Baseline to Week 16
Title
Change from Baseline in Urticaria Control Test (UCT) Score
Time Frame
Baseline to Week 16
Title
Change from Baseline in Angioedema Activity Score over 7 Days (AAS7)
Time Frame
Baseline to Week 16
Title
Number of Cumulative Weeks that Participants are Angioedema Occurrence-free using the Angioedema Activity Score over 7 Days (AAS7)
Time Frame
Baseline to Week 16
Title
Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Score
Time Frame
Baseline to Week 16
Title
Change from Baseline in Dermatology Life Quality Index (DLQI) Score
Time Frame
Baseline to Week 16
Title
Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score
Time Frame
Baseline to Week 16
Title
Change from Baseline in Angioedema Control Test (AECT) Score
Time Frame
Baseline to Week 16
Title
Number of Participants with Complete Control in Angioedema Control Test (AECT)
Description
Complete control is defined as having an AECT score of 16 at week 16.
Time Frame
Week 16
Title
Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score
Time Frame
Baseline to Week 16
Title
Total Number of H1-antihistamine Rescue Medication Uses
Time Frame
Baseline to Week 16
Title
Maximum Observed Concentration of Tezepelumab in Serum (Cmax)
Time Frame
Baseline to Week 16
Title
Number of Participants who Experience an Adverse Event (AE)
Time Frame
Baseline to Week 32
Title
Number of Participants who Experience a Serious Adverse Event (SAE)
Time Frame
Baseline to Week 32

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

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