Sanofi looks to advance CSU drug rilzabrutinib in Phase III trial

Sanofi’s rilzabrutinib improved itch, hives, and urticaria in a Phase II trial in patients with chronic spontaneous urticaria (CSU).

Phalguni Deswal February 26 2024

Sanofi shared positive results from the Phase II trial of rilzabrutinib in patients with moderate to severe chronic spontaneous urticaria (CSU).

The Phase II RILECSU study (NCT05107115) showed an improvement in CSU symptoms such as itching, hives and urticaria in CSU patients whose symptoms are inadequately controlled by H1-antihistamines.

The RILECSU trial formed the basis of the Phase III study, which is expected to start later this year.

Rilzabrutinib is a Burton tyrosine kinase (BTK) inhibitor acquired by Sanofi in 2020 as part of its $3.68bn acquisition of Principia. The drug has yet to show positive results in late-stage clinical trials. In 2021, rilzabrutinib failed to show improvement in the Phase III trial (NCT03762265) as a treatment for a rare autoimmune skin disease, pemphigus.

The drug also failed to meet the eczema area and severity endpoint in the Phase II atopic dermatitis trial (NCT05018806). Sanofi noted that “numerical improvements were seen in other important clinical components” of atopic dermatitis.

The RILECSU trial met its primary endpoint by demonstrating a reduction in weekly itch severity score (ISS7) and weekly urticaria activity score (UAS7) at 12 weeks compared to baseline. Patients in the rilzabrutinib group also showed a reduction in weekly hives severity score (HSS7) at 12 weeks compared to the baseline. The treatment-emergent adverse effects included diarrhoea, nausea, headache, and abdominal pain.

Chronic spontaneous urticaria, also known as chronic hives, is a skin condition that causes red, raised, and itchy hives that are occasionally painful. The hives last for six weeks or more and are managed symptomatically with antihistamines, antipruritic, and anti-inflammatories.

Sanofi also has another CSU therapy in its portfolio, Dupixent (dupilumab). The blockbuster therapy was developed in partnership with Regeneron. This month, it was approved as a treatment for CSU in patients aged 12 years and older by the Japanese Ministry of Health, Labor and Welfare

Sanofi is also evaluating rilzabrutinib in multiple autoimmune indications, including a Phase III trial (NCT04562766) for heavily pre-treated immune thrombocytopenia and Phase II trials in warm autoimmune haemolytic anaemia (NCT05002777), IgG4-related disease (NCT04520451), and moderate to severe asthma (NCT05104892). The readouts from the Phase II trials are expected this year.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close