Neuropathic Diabetic Foot UlcersPhase 1NCT02833389
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers
A Phase 1 study testing UTTR1147A in people with Neuropathic Diabetic Foot Ulcers, run by Genentech, Inc. at 32 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Diabetic Foot Ulcers
- What is being tested?
- UTTR1147A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 14 Nov 2016to 12 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States10 sites
Clinical Research Associates Of Central Pa , Llc
Altoona, Pennsylvania, 16602
Podiatry 1st
Belleville, Illinois, 62226
Animas Foot and Ankle
Durango, Colorado, 81301
Futuro Clinical Trials
McAllen, Texas, 78501-2930
East Valley Foot and Ankle Specialists
Mesa, Arizona, 85206
GF Professional Research Group Corporation
Miami Lakes, Florida, 33016
Endeavor Clinical Trials PA
San Antonio, Texas, 78229
Center for Clinical Research Inc.; i
San Francisco, California, 94115
1Foot 2Foot Centre for Foot & Ankle Care PC
Suffolk, Virginia, 23434
Steven M. Waldman, SC
Wauwatosa, Wisconsin, 53226
United Kingdom8 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Royal Derby Hospital; Medical School
Derby, DE22 3DT
Ipswich Hospital
Ipswich, IP4 5PD
St James University Hospital
Leeds, LS9 7TF
Kings College Hospital
London, SE5 9RS
University of East Anglia
Norfolk, NR4 7TJ
Nottingham City Hospital
Nottingham, NG5 1PB
Northern General Hospital
Sheffield, S5 7AU
Spain5 sites
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, 28922
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitario de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080
Universidad Complutense de Madrid
Madrid, 28040
Denmark3 sites
Aalborg Universitetshospital
Aalborg, 9000
Bispebjerg Hospital
Copenhagen, 2400
Odense Universitetshospital; Endokrinologisk Afdeling
Odense, 5000
Hungary3 sites
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, 8230
Semmelweis Egyetem
Budapest, 1083
Kenezy Korhaz Rendelointezet
Debrecen, 4031
Italy3 sites
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100
Policlinico Universitario Campus Biomedico Di Roma; Farmacia
Rome, Lazio, 00128
About this study
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
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.
- Conditions
- Neuropathic Diabetic Foot Ulcers
- Being tested
- Placebo, UTTR1147A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
UTTR1147A matching placebo will be administered SC.
UTTR1147ADrug
Also called RO7021610
UTTR1147A will be administered SC.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: UTTR1147A |
| 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). Receives: Drug: UTTR1147A |
| 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). Receives: Drug: UTTR1147A |
| 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). Receives: Drug: UTTR1147A |
| Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 | 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 3 for 12 weeks (a total of 4 doses). Receives: Drug: UTTR1147A |
| Placebo | Placebo comparator | Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: Baseline up to Day 141
Secondary outcomes (3)
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Measured: Baseline, Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Measured: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Serum Concentration of UTTR1147A
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start14 Nov 2016
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Diabetic Foot UlcersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833389
- Sponsor's protocol ID
- GX29915
- Other IDs
- 2015-003283-36, 2015
- Status last verified
- Nov 2018
- First submitted
- 12 Jul 2016
- Last updated
- 21 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02833389
- Acronym / sponsor ID
- GX29915
- Conditions
- Neuropathic Diabetic Foot Ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1 | Experimental | Drug: UTTR1147AParticipants 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 B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2 | Experimental | Drug: UTTR1147AParticipants 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 C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2 | Experimental | Drug: UTTR1147AParticipants 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 D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2 | Experimental | Drug: UTTR1147AParticipants 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 E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 | Experimental | Drug: UTTR1147AParticipants 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). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboUTTR1147A matching placebo will be administered SC. | Drug | Placebo |
| UTTR1147AAlso: RO7021610UTTR1147A will be administered SC. | Drug | Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1, Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2, Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2, Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2, Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: Baseline up to Day 141
3 secondary outcomes
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Time frame: Baseline, Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Time frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UTTR1147A in people with Neuropathic Diabetic Foot Ulcers, run by Genentech, Inc. at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, United Kingdom, Spain, Denmark, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (time frame: Baseline up to Day 141). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.