Health TrialsbyHealthPanel

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

ConditionRelapsing Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorTG Therapeutics, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Known presence or suspicion of other neurologic disorders that may mimic MS.

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).

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ublituximab

    Drug

    Administered as an intravenous (IV) infusion.

  • Placebo

    Drug

    Oral capsule.

  • Placebo

    Drug

    IV infusion.

  • Fingolimod

    Drug

    Oral capsule.

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A: UblituximabExperimental treatment 1 intervention
Group B: Part B: UblituximabExperimental treatment 1 intervention
Group C: Part B: PlaceboPlacebo comparator 1 intervention
Group D: Part B: FingolimodExperimental treatment 1 intervention
Group E: Part B: IV PlaceboPlacebo comparator 1 intervention
Group F: Part C: OLEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab

Time frame
Predose and multiple timepoints up to Week 24
2

Part A: Maximum Observed Concentration (Cmax) of Ublituximab

Time frame
Day 1 and Day 15
3

Part A: Participant B Cell Counts

Time frame
Up to Week 24
4

Part B: Annualized Relapse Rate (ARR)

Time frame
Up to 96 weeks

Secondary outcomes

1

Part A, B and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame
Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
2

Part A, B and C: Number of Participants With Change in Columbia-Suicide Severity Rating Scale (C-SSRS )

Time frame
Part A: Up to Week 24; Part B: Up to 96 weeks; Part C: Up to 168 weeks
3

Part A: Serum Concentrations of Ublituximab

Time frame
Up to Week 24
4

Part A and B: Percentage of Participants with Treatment-emergent Anti-drug Antibodies (ADAs) to Ublituximab

Time frame
Part A: Up to Week 24; Part B: Up to 96 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TG Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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