View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 23, 2021updated 12 Jul 2022 11:18am

AstraZeneca initiates dosing in dermatological trials of Fasenra 

AstraZeneca has dosed the first subjects in three clinical trials of monoclonal antibody Fasenra (benralizumab) for the treatment of skin diseases.

AstraZeneca has dosed the first subjects in three clinical trials of monoclonal antibody Fasenra (benralizumab) for the treatment of skin diseases.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The studies include one Phase III clinical trial in bullous pemphigoid (BP) and two Phase II studies in atopic dermatitis (AD) and chronic spontaneous urticaria (CSU).

In-licensed from BioWa, Fasenra attaches to IL-5 receptor alpha on eosinophils and draws natural killer cells to trigger apoptosis for quick and near-complete blood and tissue eosinophil depletion.

AstraZeneca is currently assessing the antibody in nine Phase II and Phase III trials in patients with eosinophilic immune dysfunction (EID) diseases, excluding severe asthma.

The Phase III FJORD trial is assessing the efficacy and safety of Fasenra in patients with BP.

The Phase II HILLIER trial and the Phase II ARROYO trial are analysing the efficacy and safety of benralizumab in moderate to severe AD and moderate to severe CSU, respectively.

Data readout from these three trials is anticipated after next year.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “These trials may provide future treatment options as we follow the science to better understand the role of eosinophils in these often debilitating skin diseases.

“This progress is yet another important step towards our ambition to bring Fasenra to patients beyond severe asthma, through our extensive clinical programme covering a broad range of dermatological, gastrointestinal and systemic inflammatory illnesses.”

Fasenra is also being studied in a Phase III RESOLUTE study for severe chronic obstructive pulmonary disease (COPD) treatment, OSTRO and ORCHID trials for chronic rhinosinusitis with nasal polyps, a MESSINA trial for eosinophilic esophagitis, and a NATRON trial for patients with hypereosinophilic syndrome.

The antibody is also being analysed in Phase III MANDARA and HUDSON trials for treating patients with eosinophilic granulomatosis with polyangiitis and eosinophilic gastritis/eosinophilic gastroenteritis, respectively.

Fasenra is approved as an add-on maintenance therapy for severe eosinophilic asthma in countries, including the US, EU, and Japan.

In January last year, AstraZeneca started three new clinical trials to evaluate Fasenra for the treatment of eosinophil-driven skin diseases.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena