1368-0024 long term extension of spesolimab in PPP
Research type
Research Study
Full title
An open-label, single arm, long term trial of Spesolimab treatment in patients with Palmoplantar Pustulosis (PPP) who have completed previous BI Spesolimab trials
IRAS ID
283913
Contact name
Andrew Pink
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2020-000189-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 5 months, 4 days
Research summary
This is a study to evaluate the long-term safety and efficacy of an experimental drug called Spesolimab in patients with Palmoplantar Pustulosis (PPP) who took part in previous studies with Spesolimab.
This is an open label trial in patients with PPP and all patients will receive open label treatment (i.e. all patients will know that they will receive 600mg of Spesolimab every 4 weeks). All patients will have participated in a previous trial and will be eligible to roll over into this extension study as long as they meet all the required selection criteria at the end of treatment visit for their previous trial. Participation in the trial is voluntary and is expected to last approximately 5 years as long as the patient continues to benefit from the treatment and does not suffer from any side effects that requires treatment to be stopped.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0306
Date of REC Opinion
13 Nov 2020
REC opinion
Further Information Favourable Opinion