chronic spontaneous urticaria
Conditions
Interventions
- Investigational drugs: SAR444671
- Pharmaceutical form: tablet
- Route of administration: oral
Sponsors
Genzyme Europe BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants who have a diagnosis of CSU refractory to H1-AH at the time of randomization - Diagnosis of CSU >=3 months prior to screening visit (Visit 1). - The presence of itch and hives for >=6 consecutive weeks at any time prior to screening visit (Visit 1) despite the use of H1-AH during this time period. - Participants using a study defined H1-AH for CSU treatment. For participants on stable doses of non-study-approved H1-AH, investigators may switch participants to an equivalent dose of a study-approved H1-AH maintenance medication. - Participants who are omalizumab naïve OR omalizumab-incomplete responders. - Participants must be willing and able to complete a daily symptom e-diary for the duration of the study. - During the 7 days before randomization: UAS7 >=16 and ISS7 >=8 - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Clearly defined underlying etiology for CUs other than CSU (main manifestation being physical urticaria) - Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes. - Participants with active atopic dermatitis (AD). - Severe concomitant illness(es) that, in the Investigator*s judgment, would adversely affect the patient*s participation in the study. - Known or suspected immunodeficiency, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator. - History of serious infections requiring intravenous (IV) therapy with the potential for recurrence (as judged by the Site Investigator and the Sponsor Medical Monitor) with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher), including active coronavirus disease 2019 (COVID-19) - Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening. - Active malignancy or history of malignancy within 5 years - Conditions that may predispose the participant to excessive bleeding - Any participant with an uncontrolled disease state as judged by the Investigator, such as asthma, psoriasis, or inflammatory bowel disease, etc. that are typically treated with oral or parenteral corticosteroids - Previous use of a BTK inhibitor. - Has received any investigational drug (or is currently using an investigational device) within the 30 days before Day 1, or at least 5 times the respective elimination half-life time (whichever is longer). - Previous exposure to another investigative drug for CSU - Positive for human immunodeficiency virus (HIV) antibody test. - Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with positive DNA test result at screening or within 3 months prior to the screening visit. - Positive hepatitis C antibody test result at screening or within 3 months prior to the screening visit. - Tuberculosis infection - Any of significant laboratory abnormalities and ECG findings at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of rilzabrutinib in study participants with chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamines (H1-AH) | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of rilzabrutinib on urticaria activity composite endpoint and itch or hives, separately, at various time points • To evaluate safety outcome measures • To assess the plasma PK of rilzabrutinib in participants with CSU | — |
Countries
Netherlands
Outcome results
None listed