Neuropathic Diabetic Foot Ulcers
Conditions
Brief summary
This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.
Interventions
DRUGPlacebo
UTTR1147A matching placebo will be administered SC.
DRUGUTTR1147A
UTTR1147A will be administered SC.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy * Have adequate circulation to the foot * Have an ulcer area at screening up to 6 cm\^2 * Up to date on all age-appropriate cancer screenings per local standards
Exclusion criteria
* Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection * Have gangrene present on any part of the affected foot * Known peripheral arterial disease requiring revascularization * Have a glycated hemoglobin A1C level of greater than (\>) 15% assessed at screening * Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents * Have active malignancy or any history of a malignancy * Use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | Baseline up to Day 141 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12 | Baseline, Weeks 6 and 12 |
| Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies | Day 1, 22, 64, 85, 99, early termination visit (up to Day 141) |
| Serum Concentration of UTTR1147A | Pre-dose (0 h) on Days 1, 22, 43, and 64, on Days 4, 8, 71, 85, and 99, early termination (up to Day 141) |
Countries
Denmark, Hungary, Italy, Spain, United Kingdom, United States
Outcome results
None listed