Vumerity for Peripheral Artery Disease

Recruiting in Palo Alto (17 mi)

Overseen by Song-Young Park, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Nebraska

Must not be taking: Dimethyl fumarate

Disqualifiers: Pregnancy, Renal impairment, Hepatic impairment, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are using dimethyl fumarate or have a hypersensitivity to diroximel fumarate or its ingredients.

Eligibility Criteria

This trial is for individuals aged 50-75 with Peripheral Artery Disease (PAD) who experience leg pain during exercise and are not currently pregnant or nursing. They must not have severe PAD that has led to tissue loss, nor should they have kidney problems. Age-matched controls without PAD can also join if they don't have other diseases limiting exercise.

Inclusion Criteria

I am not taking dimethyl fumarate for my PAD.

PAD subjects must demonstrate a history of exercise-induced claudication

I do not have blocked arteries in my legs (ankle-brachial index > 0.90).

Exclusion Criteria

PAD subjects will be deemed ineligible if they have not had a physical exam to assess exercise limitations in the past year

PAD subjects will be deemed ineligible if they have an indication of hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY

I am not taking dimethyl fumarate.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Vumerity or placebo, followed by a crossover after a minimum of 7 days

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood work assessment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Diroximel Fumarate (Nrf2 Activator)

Trial Overview The study tests whether a drug called Vumerity improves antioxidant capacity, reducing oxidative stress and enhancing blood vessel function and walking ability in people with PAD. Participants will receive either Vumerity or a placebo, and their vascular function and walking capacity will be evaluated through various medical tests.

Participant Groups

Group I: PAD: Vumerity intake, then Placebo Experimental Treatment 2 Interventions

Participants with peripheral artery disease (PAD) will receive a single dose of VUMERITY (diroximal fumarate, 462mg). After a minimum period of 7 days, they will then receive a single dose of the placebo (microcrystalline cellulose, 462 mg).

Group II: Control: Vumerity intake, then Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of VUMERITY (diroximal fumarate, 462mg). After a minimum period of 7 days, they will then receive a single dose of the placebo (microcrystalline cellulose, 462 mg).

Group III: Control: Placebo intake, then Vumerity Placebo Group 2 Interventions

Participants will receive a single dose of placebo (microcrystalline cellulose, 462 mg). After a minimum period of 7 days, they will then receive a single dose of VUMERITY (diroximal fumarate, 462mg).

Group IV: PAD: Placebo intake, then Vumerity Placebo Group 2 Interventions

Participants with peripheral artery disease (PAD) will receive a single dose of placebo (microcrystalline cellulose, 462 mg). After a minimum period of 7 days, they will then receive a single dose of VUMERITY (diroximal fumarate, 462mg).

Diroximel Fumarate is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Vumerity for:

• Multiple sclerosis

🇪🇺 Approved in European Union as Vumerity for:

• Relapsing-remitting multiple sclerosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Nebraska - Omaha Omaha, NE

Who Is Running the Clinical Trial?

University of Nebraska Lead Sponsor

References