GX29915: UTTR1147A in Diabetic Foot Ulcers
Research type
Research Study
Full title
A PHASE Ib, BLINDED, RANDOMIZED, MULTICENTER, MULTIPLE-ASCENDING −DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF UTTR1147A ADMINISTERED BY SUBCUTANEOUS INJECTION IN PATIENTS WITH NON-HEALING NEUROPATHIC DIABETIC FOOT ULCERS
IRAS ID
196164
Contact name
Frances Game
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2015-003283-36
Duration of Study in the UK
1 years, 8 months, 22 days
Research summary
Ulceration of the foot associated with diabetes mellitus is a common and disabling condition. Besides control of the underlying diabetes, the current best standard of care (SOC) for Diabetic Foot Ulcers (DFUs) includes local ulcer care with frequent cleaning and debridement, (removal of dead and hard skin, usually with a scalpel) control of any infection, pressure-relieving strategies, and restoration of blood flow to the foot if needed.
The aim of this study is to test the safety of study drug UTTR1147A at different dose levels. UTTR1147A is a version of a protein called interleukin-22 which helps to fight infection and repair tissue damage by encouraging the growth of new tissue. There is currently only one ongoing study of UTTR1147A in healthy volunteers. Because the results are blinded, not all of the side effects of this treatment are known.
This study is sponsored by Genentech Inc. About 66 - 90 patients, will take part in this double blind placebo controlled study at approximately 15 sites in Europe. There will be at least 18 study visits if the patient’s ulcer remains open through the duration of treatment. If the patient’s ulcer is still open at the end of the treatment period, the patient will be followed weekly and SOC ulcer treatment will continue for 8 weeks in the observation period. If an ulcer is confirmed closed at any time during the study, the patient may be followed every 4 weeks during the observation period. Procedures involved include a physical examination, vital signs (pulse and blood pressure), blood tests, ECGs, a foot X-Ray, tests for blood flow to the affected foot and DFU related assessments.Based on the patient’s status of their DFU at the end of the 2-week run-in period (infected or not), patients will be randomly assigned to one of 4 treatment cohorts (A. B, C or D) to receive either UTTR1147A or placebo. Cohorts A, B, or D, will have a 2 to 1 chance of being treated with UTTR1147A. Group C have an equal chance of receiving either UTTR1147A or placebo. Patients in Cohort D will undergo small biopsies from the edge of the ulcer in addition.
Neither the participant nor the study doctor will know what treatment was assigned.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0040
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion