Study to investigate the use of benralizumab in chronic spontaneous urticaria

Phase 1

Conditions: chronic spontaneous urticaria
MedDRA version: 20.0Level: PTClassification code 10046735Term: UrticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2020-000169-17-BG

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Adult participants = 18 years of age
2.Physician-confirmed diagnosis of CSU (also known as chronic idiopathic urticaria) for at least 6 months prior to screening (Visit 1).
3. Presence of pruritus and wheals for at least 6 consecutive weeks prior to screening (Visit 1), despite receiving standard of care, which may include second generation H1 antihistamines (at approved or up to 4-times approved doses) as monotherapy or in combination with LTRAs and/or H2 blockers.
4. Symptomatic during run-in, defined by the following:
(a) UAS7 total score of = 16 with an ISS7 of = 8, during the 7 days prior to randomisation (Visit 2)
(b) In-clinic UAS total score of = 4 on at least one of the screening days.
5. Willing to use a second-generation H1 antihistamine at the approved dose and as monotherapy from the screening visit (Visit 1) until the end of the study.
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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Participants with predominant inducible urticarial
2. Participants with diseases, other than chronic urticaria, with urticaria or angioedema symptoms such as urticaria vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema. Additionally, any other skin disease associated with chronic itching and/or skin lesions that, in the investigators opinion, might influence the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.)
3. Current malignancy, or history of malignancy, with the exception of:
(a) Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to the date informed consent, was obtained.
(b) Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent, was obtained.
4. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
(a) Affect the safety of the participant throughout the study
(b) Influence the findings of the studies or their interpretations
(c) Impede the participant’s ability to complete the entire duration of study.
5. History of anaphylaxis to any biologic therapy or vaccine.
6. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.
7. Current active liver disease
8. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
9. Use of immunosuppressive medication, including, but not limited to: methotrexate, cyclosporine, azathioprine, topical and systemic corticosteroids within 4 weeks or 5 half-lives prior to the date informed consent is obtained, whichever is longer.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the clinical efficacy of benralizumab compared to placebo in patients with CSU who are<br>symptomatic despite the use of H1 antihistamine treatment.;Secondary Objective: 1. To evaluate the effect of benralizumab compared to placebo on supportive measures of clinical efficacy <br>2. To evaluate the effect of benralizumab on patient reported health-related quality of life measures 3. To assess the PK and immunogenicity of benralizumab<br>4. To evaluate the longer-term effect of benralizumab compared to placebo at Week 24 on measures of clinical efficacy<br>5. To evaluate the efficacy of administration of 2 dosing regimens of benralizumab up to Week 52;Primary end point(s): Change from baseline in ISS7 at week 12;Timepoint(s) of evaluation of this end point: at week 12

Secondary Outcome Measures

Name	Time	Method

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