30 Participants Needed

Cladribine Tablets for Multiple Sclerosis

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Overseen ByJudy Button
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Keith Edwards, M.D.
Must be taking: Cladribine tablets
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.

Will I have to stop taking my current medications?

The trial requires that certain medications be stopped before participation. Specifically, treatments like ocrelizumab, rituximab, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, interferon, glatiramer acetate, and systemic corticosteroids must be stopped for specified periods before the trial. However, medications for spasticity or neuropathic pain can be continued if they have been stable for at least 30 days before screening.

What data supports the effectiveness of the drug Cladribine Tablets for treating multiple sclerosis?

Research shows that Cladribine Tablets, marketed as Mavenclad, are effective in treating relapsing multiple sclerosis, with studies indicating that 75% of patients experienced benefits for up to 4 years with a specific dosing schedule.12345

Is cladribine safe for humans?

Cladribine tablets, used for treating multiple sclerosis, have been studied for their long-term safety. They are generally considered safe, but they can temporarily lower the number of immune cells, which might affect how well vaccines work.23467

What makes the drug Cladribine Tablets unique for treating multiple sclerosis?

Cladribine Tablets are unique because they are taken orally and work by selectively targeting and reducing certain immune cells, which helps manage multiple sclerosis. This is different from many other treatments that require injections or infusions.89101112

Research Team

KR

Keith R Edwards, M.D.

Principal Investigator

MS Center of Northeastern New York, P.C.

Eligibility Criteria

This trial is for adults aged 21-65 with clinically definite Secondary Progressive Multiple Sclerosis (SPMS) who are neurologically stable and have chosen Cladribine Tablets as their treatment. Participants must be healthy otherwise, not pregnant or breastfeeding, agree to use effective contraception, and commit to follow-ups for two years post-study.

Inclusion Criteria

I am between 21 and 65 years old.
If female: must have a negative serum pregnancy test at screen and week 48 and a negative urine pregnancy test at baseline. All females must agree to notify us immediately if they have concern of possible pregnancy
My neurological condition has been stable for more than 30 days.
See 16 more

Exclusion Criteria

I have a liver condition or history of heavy drinking.
Any other significant medical condition that in the opinion of the investigator that could potentially cause interference of complications of subject taking study Investigational Product (IP)
I do not have conditions like TBI, meningitis, stroke, or recent drug abuse that could affect brain tests.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Run-in

Subjects will have a 28 day run-in period consisting of 2 visits at week -4 and week -2

4 weeks
2 visits (in-person)

Treatment

Participants receive cladribine tablets according to the current FDA package guidelines

96 weeks
Visits at week 4, 8, 12, 16, 24, 36, 48, 52, 56, 60, 72, 84, 96

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Cladribine Tablets
Trial OverviewThe study tests if biomarkers can detect MS activity in patients taking Cladribine Tablets, potentially guiding treatment changes to prevent dysfunction. It involves routine clinic visits and assessments over a two-year period following FDA guidelines.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Cladribine TabletsExperimental Treatment1 Intervention
All participants will receive cladribine tablets according to the current United States Federal Food and Drug Administration (FDA) package guidelines.

Cladribine Tablets is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Mavenclad for:
  • Relapsing-remitting multiple sclerosis
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Approved in United States as Mavenclad for:
  • Relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease
🇺🇸
Approved in United States as Leustatin for:
  • Hairy cell leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Keith Edwards, M.D.

Lead Sponsor

Trials
1
Recruited
30+

EMD Serono

Industry Sponsor

Trials
147
Recruited
27,800+
Dr. Shepard profile image

Dr. Shepard

EMD Serono

Chief Medical Officer since 2021

MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics

Miguel Fernández Alcalde

EMD Serono

Chief Executive Officer

Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School

Findings from Research

In a 96-week phase 3 trial involving 1326 patients with relapsing-remitting multiple sclerosis, cladribine tablets significantly reduced the annualized relapse rate compared to placebo (0.14 and 0.15 vs. 0.33), indicating strong efficacy in preventing disease relapses.
Cladribine treatment also lowered the risk of sustained disability progression and reduced brain lesions on MRI, but it was associated with higher rates of lymphocytopenia and herpes zoster, highlighting the need to balance benefits against potential risks.
A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.Giovannoni, G., Comi, G., Cook, S., et al.[2022]
Cladribine tablets (Mavenclad) have been shown to be effective in treating relapsing multiple sclerosis (MS) for up to 4 years in 75% of patients, based on a multicenter, 6-year observational study that monitors various biomarkers.
This study will be the first to evaluate the long-term efficacy of cladribine and the potential for reinitiating therapy after the initial treatment, providing insights into the safety and effectiveness of this oral therapy in MS management.
Efficacy of Cladribine Tablets as a Treatment for People With Multiple Sclerosis: Protocol for the CLOBAS Study (Cladribine, a Multicenter, Long-term Efficacy and Biomarker Australian Study).Maltby, VE., Lea, RA., Monif, M., et al.[2021]
In a study of 320 people with highly active relapsing multiple sclerosis treated with cladribine, over 90% did not experience worsening of disability or relapses in the first two years, indicating strong efficacy of the treatment.
The safety profile of cladribine was consistent with previous studies, with common side effects including infections and lymphopenia, but no new safety concerns were identified, suggesting it is a safe option for patients.
Cladribine tablets in people with relapsing multiple sclerosis: A real-world multicentric study from southeast European MS centers.Adamec, I., Brecl Jakob, G., Rajda, C., et al.[2023]

References

A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. [2022]
Efficacy of Cladribine Tablets as a Treatment for People With Multiple Sclerosis: Protocol for the CLOBAS Study (Cladribine, a Multicenter, Long-term Efficacy and Biomarker Australian Study). [2021]
Cladribine tablets in people with relapsing multiple sclerosis: A real-world multicentric study from southeast European MS centers. [2023]
Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients. [2022]
Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study. [2022]
Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis. [2022]
A plain language summary of the impact of vaccines against flu and chickenpox in people with multiple sclerosis treated with cladribine tablets. [2023]
A single-dose, randomized, open-label, two-period crossover bioequivalence study comparing a fixed-dose pediatric combination of lamivudine and stavudine tablet for oral suspension with individual liquid formulations in healthy adult male volunteers. [2013]
Synthesis and anti-HIV activity of some novel chain-extended phosphoramidate derivatives of d4T (stavudine): esterase hydrolysis as a rapid predictive test for antiviral potency. [2017]
Systematic review of clinical trials evaluating low doses of stavudine as part of antiretroviral treatment. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Marked inhibitory activity of masked aryloxy aminoacyl phosphoramidate derivatives of dideoxynucleoside analogues against visna virus infection. [2019]
Stavudine: A Review. [2019]