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

Phase 1

Completed

• Conditions: Neuropathic Diabetic Foot Ulcers
• Interventions: Drug: Placebo; Drug: UTTR1147A

• Registration Number: NCT02833389
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-14
• Study Start: 2016-11-14
• Status Verified: 2018-11
• Primary Completion: 2018-11-12
• Study Completion: 2018-11-12
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2	UTTR1147A	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).
Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2	UTTR1147A	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).
Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1	UTTR1147A	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).
Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2	UTTR1147A	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).
Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3	UTTR1147A	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	Baseline up to Day 141

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (32)

East Valley Foot and Ankle Specialists; 🇺🇸 Mesa, Arizona, United States

Center for Clinical Research Inc.; i; 🇺🇸 San Francisco, California, United States

Animas Foot and Ankle; 🇺🇸 Durango, Colorado, United States

GF Professional Research Group Corporation; 🇺🇸 Miami Lakes, Florida, United States

Podiatry 1st; 🇺🇸 Belleville, Illinois, United States

Clinical Research Associates Of Central Pa , Llc; 🇺🇸 Altoona, Pennsylvania, United States

Futuro Clinical Trials; 🇺🇸 McAllen, Texas, United States

Endeavor Clinical Trials PA; 🇺🇸 San Antonio, Texas, United States

1Foot 2Foot Centre for Foot & Ankle Care PC; 🇺🇸 Suffolk, Virginia, United States

Steven M. Waldman, SC; 🇺🇸 Wauwatosa, Wisconsin, United States

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