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NCT02833389
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
Phase 1 trial testing Placebo in Neuropathic Diabetic Foot Ulcers in 72 participants. Completed in 12 November 2018.
12 November 2018
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 14 November 2016 |
| Primary completion | 12 November 2018 |
| Estimated completion | 12 November 2018 |
| Sites | 32 locations across Denmark, Italy, United Kingdom, Hungary, United States, Spain |
Drugs / interventions tested
- Placebo
- UTTR1147A — full drug profile →
Conditions studied
- Neuropathic Diabetic Foot Ulcers — all drugs for Neuropathic Diabetic Foot Ulcers →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT02833389
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of UTTR1147A
Trials testing the same drug.
- NCT04386616 — A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pne · Phase 2 · completed
- NCT03650413 — An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Sever · Phase 2 · terminated
- NCT03558152 — A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab i · Phase 2 · completed
- NCT02749630 — A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis · Phase 1 · completed
Other Genentech, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02833389 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
- Last refreshed: 21 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02833389.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing