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INCEPTION: Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04833855
Collaborator
(none)
159
Enrollment
82
Locations
7
Arms
23.4
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: Tezepelumab Dose 1
  • Biological: Tezepelumab Dose 2
  • Biological: Omalizumab
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
159 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 :
Apr 15, 2021
Anticipated Primary Completion Date :
Dec 6, 2022
Anticipated Study Completion Date :
Mar 29, 2023

Arms and Interventions

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.
    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

    Primary Outcome Measures

    1. Change from Baseline in Urticaria Activity Score over 7 days (UAS7) [Baseline to Week 16]

    Secondary Outcome Measures

    1. Number of Participants with a Complete Response in Urticaria Activity Score over 7 Days (UAS7) [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) [Baseline to Week 16]

    3. Change from Baseline in Hives Severity Score over 7 Days (HSS7) [Baseline to Week 16]

    4. Number of Participants with a Urticaria Activity Score over 7 days (UAS7) Score of 6 or Below [Week 16]

    5. Number of Participants with a Change from Baseline in Urticaria Activity Score over 7 days (UAS7) of ≤ -10 [Baseline to Week 16]

    6. Number of Participants with a Complete Resolution of Itch using the Itch Severity Score over 7 Days (ISS7) [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 [Baseline to Week 16]

    8. Number of Participants with a Complete Resolution of Hives using the Hives Severity Score over 7 Days (HSS7) [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 [Baseline to Week 16]

    10. Change from Baseline in Sleep Interference Score [Baseline to Week 16]

    11. Change from Baseline in Sleep Quality Diary Items [Baseline to Week 16]

    12. Change from Baseline in Urticaria Control Test (UCT) Score [Baseline to Week 16]

    13. Change from Baseline in Angioedema Activity Score over 7 Days (AAS7) [Baseline to Week 16]

    14. Number of Cumulative Weeks that Participants are Angioedema Occurrence-free using the Angioedema Activity Score over 7 Days (AAS7) [Baseline to Week 16]

    15. Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Score [Baseline to Week 16]

    16. Change from Baseline in Dermatology Life Quality Index (DLQI) Score [Baseline to Week 16]

    17. Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score [Baseline to Week 16]

    18. Change from Baseline in Angioedema Control Test (AECT) Score [Baseline to Week 16]

    19. Number of Participants with Complete Control in Angioedema Control Test (AECT) [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 [Baseline to Week 16]

    21. Total Number of H1-antihistamine Rescue Medication Uses [Baseline to Week 16]

    22. Maximum Observed Concentration of Tezepelumab in Serum (Cmax) [Baseline to Week 16]

    23. Number of Participants who Experience an Adverse Event (AE) [Baseline to Week 32]

    24. Number of Participants who Experience a Serious Adverse Event (SAE) [Baseline to Week 32]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama Birmingham Alabama United States 35209
    2 First OC Dermatology Fountain Valley California United States 92708
    3 Avance Clinical Trials Laguna Niguel California United States 92677
    4 Jonathan Corren MD Inc Los Angeles California United States 90025
    5 Dermatology Research Associates Los Angeles California United States 90045
    6 Clinical Science Institute Santa Monica California United States 90404
    7 Asthma and Allergy Associates PC Colorado Springs Colorado United States 80907
    8 The Community Research of South Florida Miami Lakes Florida United States 33016
    9 Advanced Medical Research PC Sandy Springs Georgia United States 30328
    10 Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana United States 46250
    11 Epiphany Dermatology of Kansas, LLC Overland Park Kansas United States 66210
    12 Bluegrass Allergy Care Lexington Kentucky United States 40509
    13 Family Allergy and Asthma Research Institute Louisville Kentucky United States 40215
    14 Johns Hopkins Asthma and Allergy Center Baltimore Maryland United States 21224
    15 David Fivenson MD Professional Liability Company Ann Arbor Michigan United States 48103
    16 Clarkston Skin Research Clarkston Michigan United States 48346
    17 Henry Ford Medical Center - New Center One Detroit Michigan United States 48202
    18 Washington University School of Medicine Saint Louis Missouri United States 63110
    19 Atlantic Research Center, LLC Ocean City New Jersey United States 07712
    20 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    21 Bernstein Clinical Research Center LLC Cincinnati Ohio United States 45236
    22 Aventiv Research Inc Dublin Ohio United States 43016
    23 Clinical Partners LLC Johnston Rhode Island United States 02919
    24 The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research Knoxville Tennessee United States 37909
    25 Suzanne Bruce and Associates Houston Texas United States 77056
    26 Cutis Wellness Dermatology and Dermatopathology, PLLC Laredo Texas United States 78041
    27 Dermatology Research Institute Incorporated Calgary Alberta Canada T2J 7E1
    28 Brunswick Dermatology Centre Fredericton New Brunswick Canada E3B 1G9
    29 LEADER Research Inc. Burlington Ontario Canada L7R 4H9
    30 Lynderm Research Inc Markham Ontario Canada L3P 1X3
    31 Cheema Research Incorporated Mississauga Ontario Canada L5A 3V4
    32 Dr. S. K. Siddha Medicine Professional Corporation Newmarket Ontario Canada L3Y 5G8
    33 Allergy Research Canada Incorporated Niagara Falls Ontario Canada L2H 1H5
    34 Gordon Sussman Clinical Research Incorporated North York Ontario Canada M3B 3S6
    35 Clinique Spécialisée en Allergie de la Capitale Quebec Canada G1V 4W2
    36 Centre Hospitalier Universitaire de Brest - Hôpital Morvan Brest France 29200
    37 Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon Grenoble Cedex 9 France 38043
    38 Hôpital Saint Eloi Montpellier cedex 5 France 34295
    39 Centre Hospitalier Universitaire Archet 2 Nice France 06202
    40 Centre Hospitalier Lyon Sud Pierre Benite Cedex France 69495
    41 *Charité* Berlin Germany 12203
    42 Universitaetsklinikum Dresden Dresden Germany 01307
    43 Johannes Gutenberg Universitaet Mainz Mainz Germany 55101
    44 Laiko General Hospital of Athens Athens Greece 11527
    45 Sotiria General Hospital Athens Greece 11527
    46 Attikon University General Hospital of Athens Athens Greece 12462
    47 Andreas Syggros Hospital Athens Greece 16121
    48 George Papageorgiou General Hospital of Thessaloniki Thessaloniki Greece 56403
    49 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano Italy 20122
    50 Azienda Ospedaliero Universitaria di Modena Modena Italy 41124
    51 Fondazione Policlinico Tor Vergata Roma Italy 00133
    52 Policlinico Universitario Agostino Gemelli Roma Italy 00168
    53 IRCCS Istituto Clinico Humanitas Rozzano MI Italy 20089
    54 Azienda Ospedaliera Citta della Salute e della Scienza di Torino Torino Italy 10126
    55 Fujita Health University Bantane Hospital Nagoya-shi Aichi Japan 454-8509
    56 Hiroshima University Hospital Hiroshima-shi Hiroshima Japan 734-8551
    57 Takagi Dermatological Clinic Obihiro-shi Hokkaido Japan 080-0013
    58 Kosugi Dermatology Clinic Kawasaki-shi Kanagawa Japan 211-0063
    59 Nomura Dermatology Clinic Yokohama-shi Kanagawa Japan 221-0825
    60 Osaka Habikino Medical Center Habikino-shi Osaka Japan 583-8588
    61 Dermatology and Ophthalmology Kume Clinic Sakai-shi Osaka Japan 593-8324
    62 Nihon University Itabashi Hospital Itabashi-ku Tokyo Japan 173-8610
    63 NTT Medical Center Tokyo Shinagawa-ku Tokyo Japan 141-8625
    64 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si, Gyeonggi-do Korea, Republic of 18450
    65 Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do Korea, Republic of 13620
    66 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    67 Asan Medical Center Seoul Korea, Republic of 05505
    68 Hallym University Kangnam Sacred Heart Hospital Seoul Korea, Republic of 07441
    69 Ajou University Hospital Suwon-si, Gyeonggi-do Korea, Republic of 16499
    70 Uniwersyteckie Centrum Kliniczne Gdansk Poland 80-214
    71 AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa Lodz Poland 90-644
    72 SPZOZ Centralny Szpital Kliniczny Lodz Poland 92-213
    73 Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie Lublin Poland 20-081
    74 Clinical Research Center Spzoo Medic-R Spolka Komandytowa Poznan Poland 61-731
    75 Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina Rzeszow Poland 35-055
    76 Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski Warszawa Poland 02-473
    77 Wojskowy Instytut Medyczny Warszawa Poland 04-141
    78 Hospital del Mar Barcelona Cataluña Spain 08003
    79 Hospital de la Santa Creu i Sant Pau Barcelona Cataluña Spain 08041
    80 Hospital Universitari de Bellvitge Hospitalet de LLobregat Cataluña Spain 08907
    81 Hospital General Universitario de Valencia Valencia Comunidad Valenciana Spain 46014
    82 Hospital Arnau de Vilanova de Valencia Valencia Comunidad Valenciana Spain 46015

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT04833855
    Other Study ID Numbers:
    • 20190194
    First Posted:
    Apr 6, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Urticaria
    Chronic Urticaria
    Omalizumab
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Aug 8, 2022