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Completed

NCT Number: NCT02833389

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

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Key information

Conditions

Neuropathic Diabetic Foot Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aalborg Universitetshospital, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

UTTR1147A matching placebo will be administered SC.

UTTR1147A

Drug

UTTR1147A will be administered SC.

Other names: RO7021610

Primary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: Baseline up to Day 141

Secondary outcomes

  1. Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12

    Time frame: Baseline, Weeks 6 and 12

  2. Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies

    Time frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)

  3. 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)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.