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

Genentech

Status and phase: Completed; Phase 1

Conditions: Neuropathic Diabetic Foot Ulcers

Treatments: Drug: Placebo; Drug: UTTR1147A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02833389

GX29915

2015-003283-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 6 patient groups, including a placebo group

Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1

Experimental group

Description:

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).

Treatment:

Drug: UTTR1147A

Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2

Experimental group

Description:

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).

Treatment:

Drug: UTTR1147A

Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2

Experimental group

Description:

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).

Treatment:

Drug: UTTR1147A

Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2

Experimental group

Description:

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).

Treatment:

Drug: UTTR1147A

Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3

Experimental group

Description:

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).

Treatment:

Drug: UTTR1147A

Placebo

Placebo Comparator group

Description:

Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).

Treatment:

Drug: Placebo