NCT02833389

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2016

Typical duration for phase_1

Geographic Reach
6 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 14, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

July 12, 2016

Last Update Submit

November 20, 2018

Conditions

Neuropathic Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with Adverse Events

    Baseline up to Day 141

Secondary Outcomes (3)

  • 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)

Study Arms (6)

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

EXPERIMENTAL

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).

Drug: UTTR1147A

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

EXPERIMENTAL

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).

Drug: UTTR1147A

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

EXPERIMENTAL

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).

Drug: UTTR1147A

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

EXPERIMENTAL

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).

Drug: UTTR1147A

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

EXPERIMENTAL

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).

Drug: UTTR1147A

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PlaceboDRUG

UTTR1147A matching placebo will be administered SC.

Placebo
UTTR1147ADRUG

UTTR1147A will be administered SC.

Also known as: RO7021610
Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

East Valley Foot and Ankle Specialists

Mesa, Arizona, 85206, United States

Location

Center for Clinical Research Inc.; i

San Francisco, California, 94115, United States

Location

Animas Foot and Ankle

Durango, Colorado, 81301, United States

Location

GF Professional Research Group Corporation

Miami Lakes, Florida, 33016, United States

Location

Podiatry 1st

Belleville, Illinois, 62226, United States

Location

Clinical Research Associates Of Central Pa , Llc

Altoona, Pennsylvania, 16602, United States

Location

Futuro Clinical Trials

McAllen, Texas, 78501-2930, United States

Location

Endeavor Clinical Trials PA

San Antonio, Texas, 78229, United States

Location

1Foot 2Foot Centre for Foot & Ankle Care PC

Suffolk, Virginia, 23434, United States

Location

Steven M. Waldman, SC

Wauwatosa, Wisconsin, 53226, United States

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Odense Universitetshospital; Endokrinologisk Afdeling

Odense, 5000, Denmark

Location

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Kenezy Korhaz Rendelointezet

Debrecen, 4031, Hungary

Location

Policlinico Universitario Campus Biomedico Di Roma; Farmacia

Rome, Lazio, 00128, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50141, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56100, Italy

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, Guipuzcoa, 20080, Spain

Location

Fundacion Hospital de Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Royal Derby Hospital; Medical School

Derby, DE22 3DT, United Kingdom

Location

Ipswich Hospital

Ipswich, IP4 5PD, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

University of East Anglia

Norfolk, NR4 7TJ, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

November 14, 2016

Primary Completion

November 12, 2018

Study Completion

November 12, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

DK(3)GB(8)US(10)IT(3)HU(3)ES(5)