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

November 20, 2018 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital
      • København, Denmark, 2400
        • Bispebjerg Hospital
      • Odense, Denmark, 5000
        • Odense Universitetshospital; Endokrinologisk Afdeling
  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4031
        • Kenezy Korhaz Rendelointezet
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico Di Roma; Farmacia
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Toscana, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana
  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
    • Guipuzcoa
      • Donostia, Guipuzcoa, Spain, 20080
        • Hospital Universitario de Donostia
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario Cruces
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Derby, United Kingdom, DE22 3DT
        • Royal Derby Hospital; Medical School
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • Norfolk, United Kingdom, NR4 7TJ
        • University of East Anglia
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • East Valley Foot and Ankle Specialists
    • California
      • San Francisco, California, United States, 94115
        • Center for Clinical Research Inc.; i
    • Colorado
      • Durango, Colorado, United States, 81301
        • Animas Foot and Ankle
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • GF Professional Research Group Corporation
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Podiatry 1st
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Clinical Research Associates Of Central Pa , Llc
    • Texas
      • McAllen, Texas, United States, 78501-2930
        • Futuro Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials PA
    • Virginia
      • Suffolk, Virginia, United States, 23434
        • 1Foot 2Foot Centre for Foot & Ankle Care PC
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Steven M. Waldman, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1
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
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2
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
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2
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
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2
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
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3
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
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
PLACEBO_COMPARATOR: Placebo
Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
Drug: Placebo
UTTR1147A matching placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Baseline up to Day 141
Baseline up to Day 141

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Time Frame: Baseline, Weeks 6 and 12
Baseline, Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Time Frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GX29915
  • 2015-003283-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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