RightFit
RecruitingPhase 3

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a changed dosing plan for ublituximab in people with relapsing multiple sclerosis (MS), which causes flare-ups of symptoms. It checks safety, how well the drug works, and how the body handles it. One part is for people who had a less-than-ideal experience with prior anti-CD20 treatment, a type of immune system treatment.

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have relapsing MS that meets the study’s diagnosis rules.
  • You must be new to treatment, or have stopped a prior MS treatment before consent and waited the required time.
  • Your EDSS score, which measures disability from MS, must be 5.5 or lower at screening.
  • Your nervous system symptoms must be stable for more than 30 days before your first dose.
  • If you can become pregnant, you must agree to use accepted birth control from consent through 6 months after your last dose.
  • For Part C, you must have used an anti-CD20 drug for at least 6 months and wait the required time after stopping it before the first study visit.
  • For Part C, you must stop your current anti-CD20 drug because of a less-than-ideal experience.

Who can't join

  • You had a serious reaction to an anti-CD20 drug given through a vein.
  • You have primary-progressive MS or inactive secondary-progressive MS, forms of MS that worsen over time.
  • You have another ongoing immune system disease that is active or treated with immune therapy, or a weakened immune system. You also cannot join if you needed IV immune globulin for low immune proteins in the past 12 months.
  • You have a serious ongoing or repeated infection needing long-term treatment, or had a serious unusual infection or one linked to weak immune defenses.
  • Tests show current or past hepatitis B, or you have chronic hepatitis C. A positive hepatitis C antibody test is allowed only if a PCR test finds no hepatitis C virus.
  • You have signs or a history of suspected or confirmed PML, a serious brain infection, or received a live vaccine within 4 weeks before the first study dose.
  • You have active cancer, except adequately treated basal cell, squamous cell, or in situ cancer.
  • You have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab, even for a condition other than MS.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of RMS (2017 Revised McDonald criteria). * Participants must meet one of the following prior treatment definitions: 1. Participants naïve to treatment. 2. Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements. * Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. * Neurologically stable for \> 30 days 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 6 months after the last dose of ublituximab. * Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1. * Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience Exclusion Criteria: * History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy. * Primary-progressive multiple sclerosis (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) infection 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 hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). * 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. * Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1. * 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). Note: Other Inclusion/Exclusion criteria may apply.

Study sites (41)

AL

CA

CO

DC

FL

GA

IA

IL

IN

KS

MA

MD

MI

MN

MO

NC

NY

OH

OK

SC

TN

TX

UT

VA

WA

WI