Pilot Study of FFP104 Dose Escalation in PBC Subjects
Research type
Research Study
Full title
A Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed with Primary Biliary Cirrhosis (PBC)
IRAS ID
161472
Contact name
Gideon Hirschfield
Contact email
Sponsor organisation
Fast Forward Pharmaceuticals, B.V.
Eudract number
2014-001638-27
Duration of Study in the UK
years, 19 months, days
Research summary
This study investigates a potential new treatment for patients with Primary Biliary Cirrhosis or PBC. The study involves taking an investigational new drug called, FFP104. "Investigational" means the study drug being tested has not been previously tested for use in treating this condition.
The study drug is an antibody molecule that may help people with certain autoimmune inflammatory diseases like Primary Biliary Cirrhosis, psoriatic arthritis, psoriasis, Crohn’s disease as well as other similar diseases. Previous studies have indicated that FFP104 could be used in treating diseases with overactive immune systems or inflammatory diseases, as is the case with PBC.
The purpose of this study is to examine how effective, safe and tolerable multiple doses of FFP104 are in patients with PBC. It will also be measured how long the infused study drug stays in the body and may be used to determine the best dose of the study drug to treat patients in future clinical research studies. This study will also be studying the effect of FFP104 on the liver by evaluating laboratory tests that are used to monitor liver health.
Patients previously diagnosed with PBC who are eligible to participate in this study will receive weekly or bi-weekly infusions over a period of 12 weeks, depending on the dosage group the patient will be assigned. The total study participation will take up to 26 weeks including a 2-week screening period and a follow-up period of 12 weeks. Three hospitals in Birmingham, Newcastle and London will participate in this study as well as three hospitals in the Netherlands.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1306
Date of REC Opinion
16 Feb 2015
REC opinion
Further Information Favourable Opinion