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New treatment option for Relapsing Multiple Sclerosis
Official title Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov ID: NCT07220252
What this study is testing
What is Ublituximab?
Ublituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsing multiple sclerosis.
Also referred to as TG-1101, BRIUMVI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (\<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- for Part A and Part B:
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1). for Part C: 1\. Participants must have...
You likely can't join if
- for Part A and B:
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- Systemic corticosteroids (\>0.1 milligrams/kilogram/day [mg/kg/day], or \>5 milligrams/day [mg/day] of prednisone equivalent) or adrenocorticotropic...
- High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
- Treatment with anti-CD20 or other B cell directed treatment at any time.
See the full eligibility criteria
- for Part A and Part B:
- Diagnosis of RMS.
- EDSS at screening: 0-5.5, inclusive.
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1). for Part C: 1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for...
- for Part A and B:
- Known presence or suspicion of other neurologic disorders that may mimic MS.
- Prior treatments:
- Systemic corticosteroids (\>0.1 milligrams/kilogram/day [mg/kg/day], or \>5 milligrams/day [mg/day] of prednisone equivalent) or adrenocorticotropic hormone (ACTH) within 30 days prior to the screening MRI scan (note...
- High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
- Treatment with anti-CD20 or other B cell directed treatment at any time.
- Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time. Additional Exclusion Criteria for Part B Only (Relevant to Fingolimod Treatment):
- Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
- The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics. Exclusion Criteria for Part C: 1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible...
The study team makes the final eligibility decision.
Where it's taking place
- Gdansk, Poland
- Poznan, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gdansk, Poland; Poznan, Poland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.