A Study of MTPS9579A in Participants with Refractory Chronic Spontaneous Urticaria
- Conditions
- Refractory Chronic Spontaneous UrticariaTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-002669-16-ES
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
•Age 18-75 years
•Body mass index (BMI) of 18-38 kg/m^2 and weight >=40 kg at screening
•Diagnosis of CSU refractory to second-generation H1 antihistamine (sgH1-AHs) at the time of randomization
•Demonstrated compliance with required use of the Urticaria eDiary
•For patients on H2 antihistamines or leukotriene receptor antagonists (LTRAs) for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
•Use of contraceptive measures
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
•Previous participation in a clinical trial of MTPS9579A
•Chronic urticaria with known cause or other diseases with symptoms of urticaria or angioedema
•Skin disease associated with chronic itching
•Uncontrolled disease where flares are commonly treated with systemic corticosteroids
•History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study
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