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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04833855
Recruitment Status : Completed
First Posted : April 6, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Biological: Tezepelumab Dose 1 Biological: Tezepelumab Dose 2 Biological: Omalizumab Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2021
Actual Primary Completion Date : December 20, 2022
Actual Study Completion Date : April 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1: Omalizumab
Participants naive to anti-IgE therapies will receive omalizumab.
 Biological: Omalizumab
Subcutaneous injection.
Other Name: 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.
Experimental: Group 4: Tezepelumab Dose 2
Participants naive to anti-IgE therapies will receive tezepelumab.
 Biological: Tezepelumab Dose 2
Subcutaneous injection.
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.
Experimental: Group 7: Tezepelumab Dose 2
Participants previously treated with anti-IgE therapies will receive tezepelumab.
 Biological: Tezepelumab Dose 2
Subcutaneous injection.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Urticaria Activity Score over 7 days (UAS7) [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Number of Participants with a Complete Response in Urticaria Activity Score over 7 Days (UAS7) [ Time Frame: Week 16 ]
    Complete response is defined as having a UAS7 score of 0 at week 16.

  2. Change from Baseline in Itch Severity Score over 7 Days (ISS7) [ Time Frame: Baseline to Week 16 ]
  3. Change from Baseline in Hives Severity Score over 7 Days (HSS7) [ Time Frame: Baseline to Week 16 ]
  4. Number of Participants with a Urticaria Activity Score over 7 days (UAS7) Score of 6 or Below [ Time Frame: Week 16 ]
  5. Number of Participants with a Change from Baseline in Urticaria Activity Score over 7 days (UAS7) of ≤ -10 [ Time Frame: Baseline to Week 16 ]
  6. Number of Participants with a Complete Resolution of Itch using the Itch Severity Score over 7 Days (ISS7) [ Time Frame: Week 16 ]
    Complete resolution of itch is defined as having a ISS7 score of 0 at week 16.

  7. Number of Participants with a Change from Baseline in Itch Severity Score over 7 days (ISS7) of ≤ -5 [ Time Frame: Baseline to Week 16 ]
  8. Number of Participants with a Complete Resolution of Hives using the Hives Severity Score over 7 Days (HSS7) [ Time Frame: Week 16 ]
    Complete resolution of hives is defined as a HSS7 score of 0 at week 16.

  9. 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 ]
  10. Change from Baseline in Sleep Interference Score [ Time Frame: Baseline to Week 16 ]
  11. Change from Baseline in Sleep Quality Diary Items [ Time Frame: Baseline to Week 16 ]
  12. Change from Baseline in Urticaria Control Test (UCT) Score [ Time Frame: Baseline to Week 16 ]
  13. Change from Baseline in Angioedema Activity Score over 7 Days (AAS7) [ Time Frame: Baseline to Week 16 ]
  14. 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 ]
  15. Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Score [ Time Frame: Baseline to Week 16 ]
  16. Change from Baseline in Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline to Week 16 ]
  17. Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score [ Time Frame: Baseline to Week 16 ]
  18. Change from Baseline in Angioedema Control Test (AECT) Score [ Time Frame: Baseline to Week 16 ]
  19. Number of Participants with Complete Control in Angioedema Control Test (AECT) [ Time Frame: Week 16 ]
    Complete control is defined as having an AECT score of 16 at week 16.

  20. Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score [ Time Frame: Baseline to Week 16 ]
  21. Total Number of H1-antihistamine Rescue Medication Uses [ Time Frame: Baseline to Week 16 ]
  22. Maximum Observed Concentration of Tezepelumab in Serum (Cmax) [ Time Frame: Baseline to Week 16 ]
  23. Number of Participants who Experience an Adverse Event (AE) [ Time Frame: Baseline to Week 32 ]
  24. Number of Participants who Experience a Serious Adverse Event (SAE) [ Time Frame: Baseline to Week 32 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833855


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04833855    
Other Study ID Numbers: 20190194
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
CSU
Additional relevant MeSH terms:
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Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chronic Disease
Disease Attributes
 Pathologic Processes
Omalizumab
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs