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Pharmacokinetic/pharmacodynamic evaluation of ublituximab in patients with autoimmune diseases

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509555-13-00
Acronym
TG1101-RMS-SC101
Enrollment
164
Registered
2024-05-06
Start date
2024-05-15
Completion date
Unknown
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis, Relapsing multiple sclerosis

Brief summary

Pharmacokinetic assessment of intravenous and subcutaneous administration of ublituximab, B-cell count following intravenous and subcutaneous administration of ublituximab

Interventions

DRUGublituximab
DRUGPARACETAMOL
DRUGCETIRIZINE
DRUGUblituximab
DRUGMETHYLPREDNISOLONE
DRUGDEXAMETHASONE
DRUGDIPHENHYDRAMINE

Sponsors

Tg Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic assessment of intravenous and subcutaneous administration of ublituximab, B-cell count following intravenous and subcutaneous administration of ublituximab

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026