View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
December 24, 2021updated 11 Jul 2022 2:14pm

Boehringer’s spesolimab improves flare signs in Phase II GPP trial

In the trial, 54% of participants treated with spesolimab had no visible pustules as against 6% who received placebo.

Boehringer Ingelheim has reported that its experimental therapy, spesolimab, substantially improved signs and symptoms of flare in individuals with generalised pustular psoriasis (GPP) in Phase II Effisayil 1 clinical trial.

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.

A humanised, selective antibody, spesolimab hinders interleukin-36 receptor (IL-36R) activation.

IL-36R is a signalling pathway within the immune system associated with various autoimmune ailment pathogeneses, such as GPP.

The 12-week trial enrolled 53 subjects with a GPP flare, who were randomised into a 2:1 ratio to receive one 900mg spesolimab intravenously or placebo.

A GPP Physician Global Assessment (GPPGA) pustulation subscore of 0 indicating no visible pustules at the first week was the trial’s primary goal.

The GPPGA score of 0/1 signifying clear/almost clear skin at week one was the key secondary goal of the trial.

Findings showed that 54% of subjects in the spesolimab arm had no visible pustules versus 6% in the placebo arm, meeting the primary endpoint.

Furthermore, 43% of subjects who received spesolimab termed had clear/almost clear skin as against 11% of subjects treated with placebo.

Continued pustular and skin clearance were observed during the course of the trial with clinically significant enhancement in quality of life and symptoms including pain and fatigue reported in the treatment arm versus placebo.

Boehringer Ingelheim Dermatology Clinical Development and Medical Affairs head Dr Emmanuelle Clerisme-Beaty said: “At Boehringer Ingelheim, we are committed to finding transformative therapies to help advance treatment for people who urgently need them.

“The findings indicate that spesolimab may have a significant and positive impact on patients experiencing a GPP flare.”

A neutrophilic skin condition, GPP is caused by the build-up of neutrophils in the skin, leading to painful, sterile pustules in the body.

In September this year, Boehringer Ingelheim and Amgen have entered a clinical Phase I collaboration to evaluate a potential combination therapy for cancer.

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