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Evaluating safety, efficacy and pharmacokinetics of a modified regimen of ublituximab (ENHANCE)
EU CTIS ID: 2024-519284-18-00
What this study is testing
Part A: To assess efficacy of a modified regimen of ublituximab as measured by T1 Gd-enhancing lesions Part B: To demonstrate pharmacokinetics of ublituximab IV infusion on Day 1 compared to the conventional IV regimen of 150 mg on Day 1 and 450 mg on Day 15 Part C: To assess efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18-65 years old
- Part C: Participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements listed in Appendix B – Washout Requirement for Prior Disease Modifying Therapies prior to W1D1. Note: Any exposure to therapies listed in Exclusion Criteria #14 remain exclusionary
- Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience defined by having any of the following: a. One or more clinically reported relapse(s) b. One or more T1 Gd-enhanced lesion(s) c. Two or more new or enlarging T2 lesions on MRI d. Experiencing wearing-off effect e. B-cell repopulation between doses f. Persistent IRRs including on most recent anti-CD20 administration g. Inability to tolerate 2-hour infusion of ocrelizumab
- Part C: EDSS score ≤5.5 at screening
- Part C: Neurologically stable prior to first dose of ublituximab
- Part C: Acceptable laboratory parameters at screening
You likely can't join if
- Any severe or uncontrolled medical condition that could affect the participant’s ability to participate
- History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML)
- 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
- Females who are pregnant or nursing
- Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma
- Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications)
See the full eligibility criteria
Who can join
- 18-65 years old
- Part C: Participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements listed in Appendix B – Washout Requirement for Prior Disease Modifying Therapies prior to W1D1. Note: Any exposure to therapies listed in Exclusion Criteria #14 remain exclusionary
- Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience defined by having any of the following: a. One or more clinically reported relapse(s) b. One or more T1 Gd-enhanced lesion(s) c. Two or more new or enlarging T2 lesions on MRI d. Experiencing wearing-off effect e. B-cell repopulation between doses f. Persistent IRRs including on most recent anti-CD20 administration g. Inability to tolerate 2-hour infusion of ocrelizumab
- Part C: EDSS score ≤5.5 at screening
- Part C: Neurologically stable prior to first dose of ublituximab
- Part C: Acceptable laboratory parameters at screening
- Part C: Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab
- Willing and able to comply with the study protocol in the investigator’s judgment
- Diagnosis of RMS (2017 Revised McDonald criteria)
- Participants must meet one of the following prior treatment definitions: a. Participants naïve to treatment. b. Participants previously treated with a DMT who have discontinued treatment prior to consent and meet the washout requirements listed in Appendix B – Washout Requirement for Prior Disease Modifying Therapies prior to W1D1. Note: Therapies listed in Exclusion Criteria #14 remain exclusionary.
- EDSS score ≤ 5.5 at screening
- Neurologically stable prior to first dose of ublituximab
- Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for protocol-specified time after the last dose of ublituximab
- Acceptable laboratory parameters at screening
- Part C: 18-65 years old
- Part C: Diagnosis of RMS (2017 Revised McDonald criteria)
What rules you out
- Any severe or uncontrolled medical condition that could affect the participant’s ability to participate
- History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML)
- 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
- Females who are pregnant or nursing
- Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma
- Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications)
- Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)
- 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.)
- Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV)
- Previous serious opportunistic or atypical infection
- Evidence of chronic active or history of hepatitis B virus (HBV) as evidenced by a detectable hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive HCV Ab are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.