Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2033-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Relapsing Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Ublituximab

New Regimen

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Administered as an intravenous (IV) infusion.

Part B: Ublituximab

New Regimen

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Administered as an intravenous (IV) infusion.

Part B: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsule.

Part B: Fingolimod

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Oral capsule.

Part B: IV Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion.

Part C: OLE

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Administered as an intravenous (IV) infusion.

Interventions

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Ublituximab

Administered as an intravenous (IV) infusion.

Intervention Type DRUG

Placebo

Oral capsule.

Intervention Type DRUG

Placebo

IV infusion.

Intervention Type DRUG

Fingolimod

Oral capsule.

Intervention Type DRUG

Other Intervention Names

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TG-1101 BRIUMVI

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of RMS.
2. EDSS at screening: 0-5.5, inclusive.
3. Neurologic stability for ≥ 30 days prior to screening, and between screening and Week 1 Day 1 (W1D1).

1\. Participants must have completed Part A (Week 24 visit) or Part B (Week 96 visit) to be eligible for Part C.

Exclusion Criteria

1. Known presence or suspicion of other neurologic disorders that may mimic MS.
2. Prior treatments:

1. 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: Topical, ophthalmic, or inhaled corticosteroids are permitted).
2. High dose intravenous immunoglobulin (IVIG) or subcutaneous IG (SCIG) within 2 months prior to W1D1.
3. Treatment with anti-CD20 or other B cell directed treatment at any time.
4. Treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone at any time.

1. Treatment with fingolimod or other sphingosine-1 phosphate-1 (S1P1) modulators at any time.
2. The following antiarrhythmic drugs at Screening: Class Ia anti-arrhythmics.

1\. If the absolute lymphocyte count (ALC) is outside the specified range the participant will not be eligible to receive ublituximab in Part C.

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No