LUT017 Gel for Venous Ulcers

Overseen By Cynthia R Gonzalez

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Antoni Ribas

Must not be taking: BRAF inhibitors, Corticosteroids

Disqualifiers: Infected ulcers, Cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs). VLUs are open sores that commonly occur on the lower legs due to poor blood flow in the veins. These wounds can be painful, slow to heal, and difficult to treat, especially in older adults and people with conditions like diabetes or obesity.

LUT017 is a gel that will be applied directly to the surface of these wounds. The goal of the study is to find out if the gel is safe and well tolerated when applied once a week for up to 8 weeks. The researchers will also look for early signs of whether the gel helps the wounds heal more quickly or completely. The gel contains a medicine that has been shown in animal studies to activate natural skin repair processes and promote cell growth, potentially speeding up the healing process.

The study will involve between 12 and 18 adult participants who have had a chronic leg wound for at least 4 weeks. All participants will go through a screening process to make sure they are eligible. If they qualify, they will first complete a two-week "run-in" phase where their wound will be treated with standard medical bandages. This phase helps ensure that only participants whose wounds are not healing with normal care are included.

If participants remain eligible after this period, they will start the treatment phase. During this phase, they will come to the clinic once a week for 8 weeks to receive the LUT017 gel treatment directly on their wound. Each visit will include a physical exam, vital signs, wound evaluation, photographs of the wound, and blood tests to monitor safety.

After the 8-week treatment period, participants will return for two follow-up visits-one at 3 months and one at 6 months after their first treatment. These visits will help the researchers understand how long any benefits of the treatment might last and monitor for any delayed side effects.

In total, participants will be involved in the study for about 6.5 months and will have approximately 12 to 14 visits to the clinic. Participation is entirely voluntary, and individuals can withdraw at any time. The research team is committed to ensuring participant safety and privacy throughout the study.

Who Is on the Research Team?

Vincent Rowe, MD

Principal Investigator

University of California, Los Angeles

Antoni Ribas, M.D., PhD

Principal Investigator

University of California, Los Angeles

Steven Farley, M.D.

Principal Investigator

University of California, Los Angeles

Aksone Nouvong, MD

Principal Investigator

University of California, Los Angeles

Jessica O'Conell, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Inclusion Criteria

Adequate perfusion confirmed within the past 12 months: Dorsalis Pedis (DP) or Posterior Tibial (PT) systolic pressure ≥ 60mmHg on the study limb, Transcutaneous partial pressure oxygen (TcP02) > 30mmHg, Great toe systolic pressure > 40mmHg

Must be able and willing to provide informed consent prior to study participation

I have an open leg sore caused by poor vein circulation.

Exclusion Criteria

I cannot tolerate wearing multi-layer bandages or compression garments.

My ulcer exposes tendon, muscle, or bone.

My ulcer is not caused by vein problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Run-in

Participants receive standardized compression therapy and optimized wound care to confirm wound chronicity

2 weeks

1 visit (in-person)

Treatment

Participants receive LUT017 gel treatment once weekly for up to 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LUT017 Gel

How Is the Trial Designed?

Group I: LUT017 Gel 0.25% Once Weekly Experimental Treatment 1 Intervention

Participants receive LUT017 gel 0.25% (2.5 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Enrollment in this cohort occurs after safety review of lower dose levels under the predefined dose-escalation rules.

Group II: LUT017 Gel 0.1% Once Weekly Experimental Treatment 1 Intervention

Participants receive LUT017 gel 0.1% (1.0 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Treatment is administered in clinic following a 14-day run-in period of standardized wound care. Dose escalation proceeds according to a 3+3 design based on observed safety.

Group III: LUT017 Gel 0.03% Once Weekly Experimental Treatment 1 Intervention

Participants receive LUT017 gel 0.03% (0.3 mg/g) applied topically once weekly for up to 8 weeks to a designated chronic venous leg ulcer or non-healing cutaneous wound. Treatment is administered in clinic following a 14-day run-in period of standardized wound care. Safety, tolerability, pharmacokinetics, and wound healing parameters are evaluated throughout treatment and follow-up.

Who Is Running the Clinical Trial?

Antoni Ribas

Lead Sponsor