A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

NCT07503873
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
350
clinicaltrials.gov
Lead sponsor
TG Therapeutics, Inc.
clinicaltrials.gov
Start date
2026-04-01
clinicaltrials.gov
Number of sites
39
clinicaltrials.gov

Summary
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
clinicaltrials.gov
Short title
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
clinicaltrials.gov
Official title
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2029-05-30
clinicaltrials.gov
First posted
2026-03-31
clinicaltrials.gov
Registry last updated
2026-08-21
clinicaltrials.gov
Primary completion date
2027-07-31
clinicaltrials.gov
Start date
2026-04-01
clinicaltrials.gov

Participants
350
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
350
clinicaltrials.gov
Protocol amendments
2
clinicaltrials.gov
Number of sites
39
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
TG Therapeutics, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07503873
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07503873
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab

    Timeframe: Up to Week 12

  1. Part 1: Plasma Concentrations of Ublituximab

    Timeframe: Up to Week 24

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to Week 120

  3. Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)

    Timeframe: Up to Week 96

  4. Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab

    Timeframe: pre-dose and at multiple timepoints post-dose up to Week 120

  5. Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab

    Timeframe: pre-dose and at multiple timepoints post-dose up to Week 120

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
  2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
  3. Neurologically stable for more than (>) 30 days prior to screening and Day 1.
  4. 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.

  1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).
  2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
  3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
  4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
  5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
  6. Females who are pregnant or nursing.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • TG Therapeutics Investigational Trial SiteBihać, Bosnia and HerzegovinaRecruiting
  • TG Therapeutics Investigational Trial SiteSarajevo, Bosnia and HerzegovinaRecruiting
  • TG Therapeutics Investigational Trial SiteTuzla, Bosnia and HerzegovinaRecruiting
  • TG Therapeutics Investigational Trial SiteZenica, Bosnia and HerzegovinaRecruiting
  • TG Therapeutics Investigational Trial SiteTbilisi, GeorgiaRecruiting
  • TG Therapeutics Investigational Trial SiteTbilisi, GeorgiaRecruiting
  • TG Therapeutics Investigational Trial SiteTbilisi, GeorgiaRecruiting
  • TG Therapeutics Investigational Trial SiteTbilisi, GeorgiaRecruiting
  • TG Therapeutics Investigational Trial SiteShtip, North MacedoniaRecruiting
  • TG Therapeutics Investigational Trial SiteSkopje, North MacedoniaRecruiting
  • TG Therapeutics Investigational Trial SiteBydgoszcz, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteKatowice, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteKatowice, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteKielce, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteLodz, PolandRecruiting
  • TG Therapeutics Investigational Trial SitePoznan, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteWarsaw, PolandRecruiting
  • TG Therapeutics Investigational Trial SiteBelgrade, SerbiaRecruiting
  • TG Therapeutics Investigational Trial SiteKragujevac, SerbiaRecruiting
  • TG Therapeutics Investigational Trial SiteChernihiv, UkraineRecruiting
  • TG Therapeutics Investigational Trial SiteChernihiv, UkraineRecruiting
  • TG Therapeutics Investigational Trial SiteIvano-Frankivsk, UkraineRecruiting
  • TG Therapeutics Investigational Trial SiteIvano-Frankivsk, UkraineRecruiting
  • TG Therapeutics Investigational Trial SiteIvano-Frankivsk, UkraineRecruiting
  • TG Therapeutics Investigational Trial SiteKyiv, UkraineRecruiting

And 14 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523757-33-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)