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

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ClinicalTrials.gov Identifier: NCT02833389
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neuropathic Diabetic Foot Ulcers Drug: Placebo Drug: UTTR1147A Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ib, Blinded, Randomized, Multicenter, Multiple-Ascending−Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A Administered by Subcutaneous Injection in Patients With Non-Healing Neuropathic Diabetic Foot Ulcers
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1
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).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Name: RO7021610

Experimental: Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2
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).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Name: RO7021610

Experimental: Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2
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).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Name: RO7021610

Experimental: Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2
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).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Name: RO7021610

Experimental: Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3
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).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Name: RO7021610

Placebo Comparator: Placebo
Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
Drug: Placebo
UTTR1147A matching placebo will be administered SC.




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to Day 141 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12 [ Time Frame: Baseline, Weeks 6 and 12 ]
  2. Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies [ Time Frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141) ]
  3. Serum Concentration of UTTR1147A [ Time Frame: 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833389


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Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02833389     History of Changes
Other Study ID Numbers: GX29915
2015-003283-36 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases