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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003283-36 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| 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). |
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| Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | UTTR1147A matching placebo will be administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Baseline up to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Valley Foot and Ankle Specialists | Mesa | Arizona | 85206 | United States | ||
| Center for Clinical Research Inc.; i |
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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).
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| Placebo | Placebo Comparator | Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses). |
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| UTTR1147A |
| Drug |
UTTR1147A will be administered SC. |
|
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| 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) |
| San Francisco |
| California |
| 94115 |
| United States |
| Animas Foot and Ankle | Durango | Colorado | 81301 | United States |
| GF Professional Research Group Corporation | Miami Lakes | Florida | 33016 | United States |
| Podiatry 1st | Belleville | Illinois | 62226 | United States |
| Clinical Research Associates Of Central Pa , Llc | Altoona | Pennsylvania | 16602 | United States |
| Futuro Clinical Trials | McAllen | Texas | 78501-2930 | United States |
| Endeavor Clinical Trials PA | San Antonio | Texas | 78229 | United States |
| 1Foot 2Foot Centre for Foot & Ankle Care PC | Suffolk | Virginia | 23434 | United States |
| Steven M. Waldman, SC | Wauwatosa | Wisconsin | 53226 | United States |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
| Odense Universitetshospital; Endokrinologisk Afdeling | Odense | 5000 | Denmark |
| DRC Gyogyszervizsgalo Kozpont Kft | Balatonfüred | 8230 | Hungary |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Kenezy Korhaz Rendelointezet | Debrecen | 4031 | Hungary |
| Policlinico Universitario Campus Biomedico Di Roma; Farmacia | Rome | Lazio | 00128 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50141 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Fundacion Hospital de Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Universidad Complutense de Madrid | Madrid | 28040 | Spain |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Royal Derby Hospital; Medical School | Derby | DE22 3DT | United Kingdom |
| Ipswich Hospital | Ipswich | IP4 5PD | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| University of East Anglia | Norfolk | NR4 7TJ | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |