Clinical trial NCT02833389: The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neuropathic Diabetic Foot Ulcers
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: Baseline up to Day 141
Secondary outcomes:
measure: Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
timeFrame: Baseline, Weeks 6 and 12
measure: Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
timeFrame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
measure: Serum Concentration of UTTR1147A
timeFrame: 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)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: East Valley Foot and Ankle Specialists
state: Arizona
city: San Francisco
country: United States
facility: Center for Clinical Research Inc.; i
state: California
city: Durango
country: United States
facility: Animas Foot and Ankle
state: Colorado
city: Miami Lakes
country: United States
facility: GF Professional Research Group Corporation
state: Florida
city: Belleville
country: United States
facility: Podiatry 1st
state: Illinois
city: Altoona
country: United States
facility: Clinical Research Associates Of Central Pa , Llc
state: Pennsylvania
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials PA
state: Texas
city: Suffolk
country: United States
facility: 1Foot 2Foot Centre for Foot & Ankle Care PC
state: Virginia
city: Wauwatosa
country: United States
facility: Steven M. Waldman, SC
state: Wisconsin
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: København
country: Denmark
facility: Bispebjerg Hospital
city: Odense
country: Denmark
facility: Odense Universitetshospital; Endokrinologisk Afdeling
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma; Farmacia
state: Lazio
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
state: Guipuzcoa
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon
state: Madrid
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Derby
country: United Kingdom
facility: Royal Derby Hospital; Medical School
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Norfolk
country: United Kingdom
facility: University of East Anglia
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: