Vumerity for Peripheral Artery Disease

Overseen By Song-Young Park, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Nebraska

Must not be taking: Dimethyl fumarate

Disqualifiers: Pregnancy, Renal impairment, Hepatic impairment, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug Vumerity (Diroximel Fumarate) can aid individuals with peripheral artery disease (PAD) by reducing oxidative stress, potentially improving blood vessel function and walking ability. Participants will receive either Vumerity or a placebo to determine which is more effective for these issues. The trial seeks individuals diagnosed with PAD who experience pain when walking. As an Early Phase 1 trial, this research aims to understand how Vumerity works in people, offering participants the chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that diroximel fumarate (Vumerity) is usually well-tolerated by patients. Studies have found that switching to this drug from other treatments like glatiramer acetate or interferons is often smooth. Few people discontinue its use due to stomach-related side effects. Additionally, long-term studies of similar drugs have not identified any new safety issues. This suggests that diroximel fumarate might be safe for short-term use in people with conditions like peripheral artery disease (PAD). However, as this trial is just beginning, researchers are still learning about its full safety for this specific condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PAD?

Unlike traditional treatments for peripheral artery disease (PAD) like aspirin, statins, or surgical interventions, Vumerity (diroximel fumarate) offers a novel approach by targeting specific pathways related to inflammation and oxidative stress. This makes it stand out because it might provide benefits beyond just improving blood flow, potentially addressing underlying disease mechanisms. Researchers are particularly excited about Vumerity because it could offer a dual-action effect, not only managing symptoms but also possibly slowing disease progression, which current options do not directly address. Plus, Vumerity's oral administration could offer convenience compared to invasive procedures.

What evidence suggests that Vumerity might be an effective treatment for peripheral artery disease?

This trial will evaluate diroximel fumarate, also known as Vumerity, for its potential to increase antioxidant levels in participants with peripheral artery disease (PAD). Antioxidants help reduce oxidative stress, which is linked to blood vessel problems in PAD. In other conditions, such as multiple sclerosis, Vumerity has shown promise in helping patients. It is believed to work by activating a process that protects cells from damage. Although not yet proven for PAD, its ability to boost the body's defense against oxidative stress makes it a hopeful option for improving blood vessel health and walking ability in people with PAD. Participants in this trial will receive Vumerity and a placebo in different sequences to assess its effects. ^{1 3 4 6 7}

Who Is on the Research Team?

Song-Young Park, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Diroximel Fumarate

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06319339

Study Details | NCT06319339 | Impact of Nrf2 Activation on ... The purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8870078/

Efficacy and Safety Outcomes with Diroximel Fumarate ... The data suggest that transition to DRF from GA, IFN, or DMF is a reasonable treatment strategy, with low rates of discontinuation due to GI AEs.

3. sigma.larvol.com sigma.larvol.com/product.php?e1=22581&tab=newstrac

Vumerity (diroximel fumarate) News These preliminary findings suggest that transition to DRF from OCRE may be an effective treatment option for people with RRMS who are clinically stable but may ...

4. vumerityhcp.com vumerityhcp.com/en_us/home/additional-studies/neda-3-study.html

NEDA-3 Study | VUMERITY® (diroximel fumarate) An open-label, single-arm, 96-week, phase 3 study to evaluate DRF safety, tolerability, and exploratory efficacy endpoints in adults with RRMS.

5. tga.gov.au tga.gov.au/sites/default/files/2023-02/auspar-vumerity-230210-pi.pdf

AusPAR - Vumerity – diroximel fumarate Data from healthy volunteer studies suggest that dimethyl fumarate-associated flushing is likely to be prostaglandin mediated. A short course of ...

6. vumerityhcp.com vumerityhcp.com/en_us/home/additional-studies/long-term-study.html

VUMERITY® (diroximel fumarate) Safety Study The longest clinical follow-up of DMF exposure to date · 45% reduction in ARR over 10 years of DMF treatment (0.20 Year 1 vs 0.11 Years 9-10) · 56% reduction in ...

7. tga.gov.au tga.gov.au/sites/default/files/2023-02/auspar-vumerity-230210.docx

AusPAR: Vumerity The sponsor has relied on data from this study to extrapolate the long term safety findings of dimethyl fumarate to diroximel fumarate.