Bazedoxifene Acetate for Multiple Sclerosis

(ReWRAP Trial)

Overseen By Ayushi Balan

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Riley Bove, MD

Must not be taking: Clemastine, Duavee, Tamoxifen, others

Disqualifiers: Cancer, Pregnancy, Thromboembolism, Cardiac block, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test whether bazedoxifene acetate, a type of medication, can repair nerve damage in women with relapsing-remitting multiple sclerosis (RRMS). Two groups will participate: one will begin the treatment immediately, while the other will have a delayed start. Women who have had RRMS for at least two years and remain stable on their current therapy might be suitable candidates. Participants can continue their usual medications but cannot join other drug studies simultaneously. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

Will I have to stop taking my current medications?

You can continue taking your standard disease-modifying treatment during the trial, but you cannot participate in any other investigational drug studies at the same time.

Is there any evidence suggesting that bazedoxifene acetate is likely to be safe for humans?

Research has shown that bazedoxifene acetate (BZA) is safe for humans. This drug already treats bone loss in postmenopausal women, so its safety has been verified for that condition. Studies have found that BZA helps repair myelin, the protective layer around nerves, in early tests. This finding is promising for its potential use in treating multiple sclerosis (MS).

Some side effects have been reported in studies, which is common in clinical research. The current trial will assess how well people with relapsing-remitting multiple sclerosis tolerate BZA over time. Participants can continue their usual MS medications, which might help reduce any unexpected side effects during the trial. ^{1 2 3 4 5}

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

Researchers are excited about Bazedoxifene Acetate for multiple sclerosis because it offers a novel approach compared to traditional therapies like interferons, glatiramer acetate, or monoclonal antibodies. Unlike these standard treatments that primarily aim to suppress the immune system or modify its activity, Bazedoxifene Acetate, a selective estrogen receptor modulator (SERM), may provide neuroprotective benefits by acting on estrogen receptors in the brain. This unique mechanism could potentially protect nerve cells and slow disease progression, offering hope for a more comprehensive treatment strategy.

What evidence suggests that bazedoxifene acetate might be an effective treatment for multiple sclerosis?

Studies have shown that bazedoxifene (BZA) can help repair myelin, the protective layer around nerves, in early tests. This is crucial for treating relapsing-remitting multiple sclerosis (RRMS), where myelin damage causes symptoms. BZA has also effectively treated bone loss in postmenopausal women, suggesting benefits for both bone and nerve health. These findings indicate that BZA could aid in myelin repair for people with RRMS. In this trial, participants in Group A will receive BZA for 6 months, while those in Group B will start with a placebo followed by BZA. Current research is exploring this potential further. ^{1 2 3 4 5}

Who Is on the Research Team?

Riley Bove, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for women aged 45-65 with relapsing-remitting multiple sclerosis (RRMS) who have been on stable immunomodulatory therapy. They must not be pregnant, planning pregnancy, or breastfeeding and should use effective contraception. Participants cannot have severe myopia, a history of certain cancers or thromboembolism, untreated B12 deficiency or hypothyroidism, significant cardiac issues, or drug/alcohol abuse in the past year.

Inclusion Criteria

My immune therapy has been stable for over 6 months with no dose changes in the last 30 days.

My disability level allows me to walk at least with a cane.

My eye test shows enough nerve fibers.

Exclusion Criteria

I have a known liver condition.

My cancer is or might be fueled by estrogen.

I have had or currently have blood clots in my veins.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bazedoxifene Acetate (BZA) as a remyelinating agent. Group A receives 6 months of BZA, while Group B receives 3 months of placebo followed by 3 months of BZA.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments including MRI, patient-reported outcomes, and safety monitoring.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bazedoxifene Acetate

Trial Overview The study tests bazedoxifene acetate's ability to repair nerve insulation (remyelination) in RRMS patients over six months. It uses electrophysiological techniques and MRI while participants continue their standard MS treatments. Women can't join other drug studies during this time.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

Group B is the "delayed-start" group and will receive a total of 3 months of BZA -- 3 months of placebo, followed by 3 months of BZA

Group II: Group A Experimental Treatment 1 Intervention

Group A is the "early-start" group and will receive a total of 6 months of BZA -- 3 months of BZA, followed by 3 months BZA

Bazedoxifene Acetate is already approved in European Union, United States for the following indications:

Approved in European Union as Conbriza for:

• Postmenopausal osteoporosis

Approved in United States as Viviant for:

• Postmenopausal osteoporosis

Who Is Running the Clinical Trial?

Riley Bove, MD

Lead Sponsor

Trials

2

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04002934

Bazedoxifene Acetate as a Remyelinating Agent in Multiple ... The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423002562

Re-WRAP (Remyelination for women at risk of axonal loss ... BZA has strong preclinical effects on myelin repair, and in the general population demonstrated benefits in treating postmenopausal osteoporosis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04002934?cond=multiple+sclerosis

Bazedoxifene Acetate as a Remyelinating Agent in Multiple ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37739167/

Re-WRAP (Remyelination for women at risk of axonal loss ... BZA has strong preclinical effects on myelin repair, and in the general population demonstrated benefits in treating postmenopausal ...

5. smartpatients.com smartpatients.com/trials/NCT04002934

Bazedoxifene Acetate as a Remyelinating Agent in Multiple ... The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple sclerosis ( ...