Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (INCEPTION)
Chronic Spontaneous Urticaria
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU
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.
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
Active Comparator
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
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
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.