Chronic spontaneous urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Sanofi aventis recherche et developpement
Eligibility
Sex/Gender
All
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. - 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 - Body mass index (BMI) >17.5 and =65 years) yes F.1.3.1 Number of subjects for this age range 73
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 or currently active moderate to severe infection at Screening, 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 antibody 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 |
|---|---|
| Main Objective: 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 Objective: • 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;Primary end point(s): 1 - Change from baseline in weekly urticaria activity score (UAS7) at Week 12 (except US and US reference countries) 2 - For US and US reference countries only: change from baseline in weekly itch severity score (ISS7) at Week 12;Timepoint(s) of evaluation of this end point: 1, 2 - From baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Change from baseline in UAS7 at Week 4 2 - Change from baseline in ISS7 at Week 12 (except US and US reference countries) 3 - For US and US reference countries only: change from baseline in UAS7 at Week 12 4 - Change from baseline in weekly hives severity score (HSS7) at Week 12 5 - Proportion of participants with UAS7 =6 at Week 12 6 - Proportion of participants with UAS7 = 0 at Week 12 7 - Percentages of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) during the double blind phase 8 - Percentages of participants experiencing TEAEs or SAEs during the open lable extension (OLE) phase 9 - Plasma PK concentrations of rilzabrutinib in participants with CSU;Timepoint(s) of evaluation of this end point: 1 - From baseline to Week 4 2, 3, 4 - From baseline to Week 12 5, 6 - At Week 12 7 - Until Week 12 8, 9 - Until Week 52 | — |
Countries
Argentina, Canada, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan
Contacts
Public ContactUnidad de Estudios Clínicos
Sanofi-Aventis, S.A
Outcome results
None listed