The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
- Conditions
- Neuropathic Diabetic Foot Ulcers
- Interventions
- Drug: PlaceboDrug: UTTR1147A
- Registration Number
- NCT02833389
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses). Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2 UTTR1147A Participants with 0.8-6.0 cm\^2 index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2 UTTR1147A Participants with 1.5-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1 UTTR1147A Participants with 0.8-6.0 centimeters square (cm\^2) index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 1 for 12 weeks (a total of 4 doses). Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2 UTTR1147A Participants with 0.8-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 UTTR1147A Participants with 0.8-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 3 for 12 weeks (a total of 4 doses).
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events Baseline up to Day 141
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (32)
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Clinical Research Associates Of Central Pa , Llc
🇺🇸Altoona, Pennsylvania, United States
Universidad Complutense de Madrid
🇪🇸Madrid, Spain
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Royal Derby Hospital; Medical School
🇬🇧Derby, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Toscana, Italy
St James University Hospital
🇬🇧Leeds, United Kingdom
GF Professional Research Group Corporation
🇺🇸Miami Lakes, Florida, United States
Podiatry 1st
🇺🇸Belleville, Illinois, United States
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Hospital Universitario de Donostia
🇪🇸Donostia, Guipuzcoa, Spain
Hospital Universitario Cruces
🇪🇸Barakaldo, Vizcaya, Spain
Kenezy Korhaz Rendelointezet
ðŸ‡ðŸ‡ºDebrecen, Hungary
Policlinico Universitario Campus Biomedico Di Roma; Farmacia
🇮🇹Roma, Lazio, Italy
Kings College Hospital
🇬🇧London, United Kingdom
Fundacion Hospital de Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Bispebjerg Hospital
🇩🇰København, Denmark
1Foot 2Foot Centre for Foot & Ankle Care PC
🇺🇸Suffolk, Virginia, United States
East Valley Foot and Ankle Specialists
🇺🇸Mesa, Arizona, United States
Center for Clinical Research Inc.; i
🇺🇸San Francisco, California, United States
Animas Foot and Ankle
🇺🇸Durango, Colorado, United States
Futuro Clinical Trials
🇺🇸McAllen, Texas, United States
Endeavor Clinical Trials PA
🇺🇸San Antonio, Texas, United States
Steven M. Waldman, SC
🇺🇸Wauwatosa, Wisconsin, United States
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Odense Universitetshospital; Endokrinologisk Afdeling
🇩🇰Odense, Denmark
DRC Gyogyszervizsgalo Kozpont Kft
ðŸ‡ðŸ‡ºBalatonfured, Hungary
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
University of East Anglia
🇬🇧Norfolk, United Kingdom