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Compares treatment options for Multiple Sclerosis
Official 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 ID: NCT07503873
What this study is testing
What is Ublituximab?
Ublituximab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple sclerosis.
Also referred to as TG-1101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).
- Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.
- Neurologically stable for more than (\>) 30 days prior to screening and Day 1.
- Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last...
You likely can't join if
- Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).
- Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
- Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
- Females who are pregnant or nursing. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Bihać, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- Tuzla, Bosnia and Herzegovina
- Zenica, Bosnia and Herzegovina
- Tbilisi, Georgia
- Shtip, North Macedonia
- Skopje, North Macedonia
- Bydgoszcz, Poland
- Katowice, Poland
- Kielce, Poland
- Lodz, Poland
- Poznan, Poland
- Warsaw, Poland
- Belgrade, Serbia
- Kragujevac, Serbia
- Chernihiv, Ukraine
- Ivano-Frankivsk, Ukraine
- Kyiv, Ukraine
- Lviv, Ukraine
- Odesa, Ukraine
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bihać, Bosnia and Herzegovina; Sarajevo, Bosnia and Herzegovina; Tuzla, Bosnia and Herzegovina; Zenica, Bosnia and Herzegovina; Tbilisi, Georgia; Shtip, North Macedonia and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.