A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability via Autoinjector Device versus Syringe in Patients with Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Tg Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

7 May 2026 → ongoing

Decision date (initial)

2026-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

TG Therapeutics, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Others

Part 1: To evaluate the PK and safety of ublituximab SC at different sites of administration
Part 2: To assess the relative bioavailability of ublituximab SC administered with AI device versus syringe

Secondary objectives 1

1. Part 2: To assess the PK of ublituximab SC Part 2: To assess the safety of ublituximab SC

Conditions and MedDRA coding

multiple sclerosis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18-65 years old
2. Diagnosis of RMS (2017 Revised McDonald criteria, see Section 17.1) and documented evidence of either a. ≥ 2 relapses in prior 2 years or 1 relapse in the one year prior to screening, and/or b. ≥1 Gd enhancing lesion in the year prior to screening
3. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening
4. Neurologically stable for > 30 days prior to Screening and Day 1
5. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab

Exclusion criteria 15

1. Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)
2. Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn’s disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.)
3. Participants with significantly impaired organ function as evidenced by the laboratory-based eligibility criteria
4. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening
5. History of life-threatening injection/infusion related reaction (IRR), hypersensitivity, or anaphylactic reaction with any component of the ublituximab solution, protocol required pre-treatment medications, or protocol required procedure medications (including magnetic resonance imaging [MRI] contrast)
6. Active infection or known history of clinically significant recurrent infection
7. History of serious opportunistic or atypical infections, including human immunodeficiency virus (HIV) and tuberculosis
8. History of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb)
9. Chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
10. History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML)
11. Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration (Day 1)
12. Any severe or uncontrolled medical condition that could affect the participant’s ability to participate
13. Females who are pregnant or nursing
14. History of any malignancy/cancer except basal cell or in situ squamous cell carcinomas of the skin that have been definitively treated
15. Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment emergent adverse events (TEAE)

Secondary endpoints 1

1. Incidence of TEAE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tg Therapeutics Inc.

Sponsor organisation

Tg Therapeutics Inc.

Address

3020 Carrington Mill Boulevard Suite 475

City

Morrisville

Postcode

27560-5435

Country

United States

Scientific contact point

Organisation

Tg Therapeutics Inc.

Contact name

Clinical Support Team

Public contact point

Organisation

Tg Therapeutics Inc.

Contact name

Clinical Support Team

Third parties 14

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications