Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous UrticariaMedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2020-002759-39-GR
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 270
•Subject has been informed about study procedures and medications
and has provided informed consent prior to initiation of any studyspecific
activities/procedures
•Subject is able to communicate with the investigator, and understands and complies with the requirements of the study
•Age = 18 to = 80 years of age at screening
•Chronic spontaneous urticaria diagnosis for = 6 months at the time of
screening visit 1
•CSU inadequately controlled by 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 enrolment
•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 visit2)
and must have documented current use on the day of screening visit 1
•This is only applicable for anti-IgE experienced subjects. Subject with
CSU who discontinued, is intolerant to, or was an inadequate responder
to anti-IgE therapies despite being treated with omalizumab 300 mg
Q4W for 6 months or higher doses of omalizumab > 2 months (or per
local country treatment standards) or another anti-IgE therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 249
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21
Disease Related:
•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 subject in the study, interfere with evaluation of the investigational product, or reduce the subject's ability to participate in the study. Clinically significant infections are defined as either of the following:
1)a systemic infection; or
2)a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication
•Diagnosis of a helminth parasitic infection within 6 months prior to screening visit 1 that had not been treated with or had failed to respond to standard of care therapy
•Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening visit 1
•Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN)
•Subjects who, in the opinion of the investigator, have evidence of active tuberculosis (TB), either treated or untreated, or a positive purified protein derivative (PPD) or QuantiFERON-tuberculosis Gold Plus (QFT-Plus) test for TB during screening. Subjects with an indeterminate
QFT-Plus may be enrolled if they have ALL of the following:
-No symptoms of TB: productive, prolonged cough (> 3 weeks);
coughing up blood; fever; night sweats; unexplained appetite loss;unintentional weight loss
-No evidence of active TB on chest radiograph within 3 months prior to
the first dose of investigational product. Note: Chest radiograph is not
part of screening procedure and will be the responsibility of the
Investigator as this is outside the scope of this protocol
Note: If required, QFT-plus test can be repeated, Subjects with the
repeated indeterminate QFT-plus should be excluded from the study.
•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 14 days sgAH stabilization period
-Completion of UAS (daily) for <11 of 14 days prior to randomization
-Completion of AAS (daily) for <11 of 14 days prior to randomization
Other Medical Conditions
•Medical examination or laboratory findings that suggest the possibility
of decompensation of co-existing conditions for the duration of the
study. Any items that are cause for uncertainty must be reviewed and
approved by the Medical Monitor
•History or evidence of severe depression, schizophrenia, previous
suicide attempts, or suicidal ideation
Prior/Concomitant Therapy
•Treatme
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method