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NCT02833389

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

Completed Phase 1 Last updated 21 November 2018
What this trial tests

Phase 1 trial testing Placebo in Neuropathic Diabetic Foot Ulcers in 72 participants. Completed in 12 November 2018.

Timeline
14 November 2016
Primary endpoint
12 November 2018
12 November 2018

Quick facts

Lead sponsorGenentech, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment72
Start date14 November 2016
Primary completion12 November 2018
Estimated completion12 November 2018
Sites32 locations across Denmark, Italy, United Kingdom, Hungary, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Genentech, Inc. — full company profile →

Who can join

18 and older, any sex, with Neuropathic Diabetic Foot Ulcers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Chronic Diabetic Wounds and Their Treatment with Skin Substitutes.
    Holl J, Kowalewski C, Zimek Z, Fiedor P, et al · · 2021 · cited 205× · PMID 33804192 · DOI 10.3390/cells10030655
  2. The IL-20 Cytokine Family in Rheumatoid Arthritis and Spondyloarthritis.
    Kragstrup TW, Andersen T, Heftdal LD, Hvid M, et al · · 2018 · cited 53× · PMID 30319661 · DOI 10.3389/fimmu.2018.02226
  3. IL-22 alters gut microbiota composition and function to increase aryl hydrocarbon receptor activity in mice and humans.
    Mar JS, Ota N, Pokorzynski ND, Peng Y, et al · · 2023 · cited 45× · PMID 36894983 · DOI 10.1186/s40168-023-01486-1
  4. The Role of T Helper 22 Cells in Dermatological Disorders.
    Pan Y, Du D, Wang L, Wang X, et al · · 2022 · cited 12× · PMID 35911703 · DOI 10.3389/fimmu.2022.911546

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Other trials of UTTR1147A

Trials testing the same drug.

Other Genentech, Inc. trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing