View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
October 13, 2020updated 12 Jul 2022 11:34am

Takeda reports positive interim data from trial of Entyvio

Takeda Pharmaceutical has reported positive interim results from the VISIBLE open-label extension (OLE) trial of a subcutaneous formulation of Entyvio (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC).

Takeda Pharmaceutical has reported positive interim results from the VISIBLE open-label extension (OLE) trial of a subcutaneous formulation of Entyvio (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC).

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.

Approved in both intravenous (IV) and subcutaneous (SC) formulations, Entyvio is a gut-selective biologic.

Comprising three Phase III studies, the VISIBLE clinical trial programme will involve over 1,000 UC and Crohn’s disease (CD) patients, which includes two randomised, double-blind, placebo-controlled studies.

The ongoing Phase IIIb multinational, multi-centre study will evaluate adults with UC enrolled in the VISIBLE 1 trial and patients with CD in VISIBLE 2 trial.

It will analyse the long-term safety and efficacy of the maintenance treatment with the subcutaneous Entyvios.

Patients who completed the 52-week maintenance period or who achieved clinical response at week 14 after a third IV infusion of Entyvio at week six were administered Entyvio SC 108mg every two weeks.

According to the interim results from the study, UC patients continued to demonstrate clinical benefit from the therapy, with rates of clinical remission and corticosteroid-free clinical remission maintained up to week 108.

Long-term safety findings were also consistent with the known safety profile of Entyvio.

Around 69% of UC patients showed adverse events but were consistent with the drug’s known safety profile.

Takeda Gastroenterology Therapeutic Area Unit head Asit Parikh said: “These latest safety and effectiveness data for vedolizumab SC provide additional support/data that the benefits received from subcutaneous vedolizumab are sustained during long-term maintenance therapy.

“Entyvio SC was approved by the European Commission in May 2020, offering greater choice on mode of administration in line with the diverse medical needs and preferences of patients, plus the option of home-administration outside of the medical setting.”

In July 2018, Takeda reported positive top-line results from the VISIBLE 1 trial after meeting its primary endpoint.

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