Neuropathic Diabetic Foot Ulcers Clinical Trial
Official 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
| Verified date | November 2018 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | November 12, 2018 |
| Est. primary completion date | November 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg Universitetshospital | Aalborg | |
| Denmark | Bispebjerg Hospital | København | |
| Denmark | Odense Universitetshospital; Endokrinologisk Afdeling | Odense | |
| Hungary | DRC Gyogyszervizsgalo Kozpont Kft | Balatonfured | |
| Hungary | Semmelweis Egyetem | Budapest | |
| Hungary | Kenezy Korhaz Rendelointezet | Debrecen | |
| Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | Toscana |
| Italy | Azienda Ospedaliero Universitaria Pisana | Pisa | Toscana |
| Italy | Policlinico Universitario Campus Biomedico Di Roma; Farmacia | Roma | Lazio |
| Spain | Fundacion Hospital de Alcorcon | Alcorcon | Madrid |
| Spain | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital Universitario Cruces | Barakaldo | Vizcaya |
| Spain | Hospital Universitario de Donostia | Donostia | Guipuzcoa |
| Spain | Universidad Complutense de Madrid | Madrid | |
| United Kingdom | Bradford Royal Infirmary | Bradford | |
| United Kingdom | Royal Derby Hospital; Medical School | Derby | |
| United Kingdom | Ipswich Hospital | Ipswich | |
| United Kingdom | St James University Hospital | Leeds | |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | University of East Anglia | Norfolk | |
| United Kingdom | Nottingham City Hospital | Nottingham | |
| United Kingdom | Northern General Hospital | Sheffield | |
| United States | Clinical Research Associates Of Central Pa , Llc | Altoona | Pennsylvania |
| United States | Podiatry 1st | Belleville | Illinois |
| United States | Animas Foot and Ankle | Durango | Colorado |
| United States | Futuro Clinical Trials | McAllen | Texas |
| United States | East Valley Foot and Ankle Specialists | Mesa | Arizona |
| United States | GF Professional Research Group Corporation | Miami Lakes | Florida |
| United States | Endeavor Clinical Trials PA | San Antonio | Texas |
| United States | Center for Clinical Research Inc.; i | San Francisco | California |
| United States | 1Foot 2Foot Centre for Foot & Ankle Care PC | Suffolk | Virginia |
| United States | Steven M. Waldman, SC | Wauwatosa | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Denmark, Hungary, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Adverse Events | Baseline up to Day 141 | ||
| Secondary | Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12 | Baseline, Weeks 6 and 12 | ||
| Secondary | Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies | Day 1, 22, 64, 85, 99, early termination visit (up to Day 141) | ||
| Secondary | 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) |