Resumen

La primera fase de este estudio será un estudio de fase 2, en grupos paralelos, de 12 semanas de tratamiento, doble ciego y de 4 brazos, para evaluar la seguridad y la eficacia de 3 dosis orales de SAR444671 (rilzabrutinib), es decir, dosis A, B y C, en comparación con placebo para reducir la frecuencia y la gravedad del prurito y la urticaria en participantes masculinos y femeninos de 18 años inclusive o más con UEC. Tras completar la fase doble ciego del estudio, se ofrecerá a los participantes la opción de inscribirse en la fase de extensión abierta (EAA) de 40 semanas del estudio. Los participantes recibirán rilzabrutinib de etiqueta abierta a la dosis C (la dosis podrá modificarse según los datos de seguridad y eficacia de las 12 semanas). Dado que algunos participantes podrían estar recibiendo rilzabrutinib por primera vez, todos los participantes serán monitoreados en la Semana 14, Semana 16, Semana 20 y Semana 24. Posteriormente, los participantes serán monitoreados en la Semana 36 y la Semana 52.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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) 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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320006

CABA, Buenos Aires, Argentina

Investigational Site Number :0320006

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina