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The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

Primary Purpose

Neuropathic Diabetic Foot Ulcers

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Placebo
UTTR1147A
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Valley Foot and Ankle Specialists
  • Center for Clinical Research Inc.; i
  • Animas Foot and Ankle
  • GF Professional Research Group Corporation
  • Podiatry 1st
  • Clinical Research Associates Of Central Pa , Llc
  • Futuro Clinical Trials
  • Endeavor Clinical Trials PA
  • 1Foot 2Foot Centre for Foot & Ankle Care PC
  • Steven M. Waldman, SC
  • Aalborg Universitetshospital
  • Bispebjerg Hospital
  • Odense Universitetshospital; Endokrinologisk Afdeling
  • DRC Gyogyszervizsgalo Kozpont Kft
  • Semmelweis Egyetem
  • Kenezy Korhaz Rendelointezet
  • Policlinico Universitario Campus Biomedico Di Roma; Farmacia
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliero Universitaria Pisana
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Universitario de Donostia
  • Fundacion Hospital de Alcorcon
  • Hospital Universitario Cruces
  • Universidad Complutense de Madrid
  • Bradford Royal Infirmary
  • Royal Derby Hospital; Medical School
  • Ipswich Hospital
  • St James University Hospital
  • Kings College Hospital
  • University of East Anglia
  • Nottingham City Hospital
  • Northern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1

Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2

Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2

Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2

Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3

Placebo

Arm Description

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).

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).

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).

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).

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).

Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events

Secondary Outcome Measures

Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Serum Concentration of UTTR1147A

Full Information

First Posted
July 12, 2016
Last Updated
November 20, 2018
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02833389
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
November 12, 2018 (Actual)
Study Completion Date
November 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Diabetic Foot Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
UTTR1147A matching placebo will be administered SC.
Intervention Type
Drug
Intervention Name(s)
UTTR1147A
Other Intervention Name(s)
RO7021610
Intervention Description
UTTR1147A will be administered SC.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline up to Day 141
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Time Frame
Baseline, Weeks 6 and 12
Title
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Time Frame
Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Title
Serum Concentration of UTTR1147A
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
East Valley Foot and Ankle Specialists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Center for Clinical Research Inc.; i
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Animas Foot and Ankle
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
GF Professional Research Group Corporation
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Podiatry 1st
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Clinical Research Associates Of Central Pa , Llc
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Futuro Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501-2930
Country
United States
Facility Name
Endeavor Clinical Trials PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
1Foot 2Foot Centre for Foot & Ankle Care PC
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23434
Country
United States
Facility Name
Steven M. Waldman, SC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Bispebjerg Hospital
City
København
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitetshospital; Endokrinologisk Afdeling
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Kenezy Korhaz Rendelointezet
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Policlinico Universitario Campus Biomedico Di Roma; Farmacia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Donostia
City
Donostia
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
Facility Name
Fundacion Hospital de Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Royal Derby Hospital; Medical School
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University of East Anglia
City
Norfolk
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

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The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

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