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New treatment option for Autoimmune Disorders
Official title Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
ClinicalTrials.gov ID: NCT07103746
What this study is testing
What is Ublituximab?
Ublituximab is an investigational medicine, being studied as a potential treatment for autoimmune disorders.
Also referred to as BRIUMVI(TM).
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
- This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy. The primary objective is to estimate the effect of ublituximab as first add-on combination therapy at 24 weeks compared to placebo in treating early, active autoantibody positive immune-mediated necrotizing myopathy using the validated 2016 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Myositis Response Criteria, as measured by the Total Improvement Score (TIS)
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be able to understand and provide informed consent.
- Age 18 years or older at disease onset.
- Definite or probable IIM per the 2017 EULAR/ACR classification criteria.
- Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies:
- Anti-SRP
You likely can't join if
- End-stage myositis with end-organ involvement that poses additional risk to the participant or confounds the assessment of the participant in the...
- Irreversible muscle involvement and/or severe atrophy that will pose additional risk to the participant or confound the assessment of the participant...
- Uncontrolled interstitial lung disease or any other uncontrolled IIM manifestation that in the opinion of the investigator would be likely to require...
- Diagnosis of other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic...
- Severe liver disease, such as signs of ascites or hepatic encephalopathy.
- History of malignancy (excluding non-melanoma skin cancer) unless cured by adequate treatment, with no evidence of recurrence for ≥ 5 years from the...
See the full eligibility criteria
Who can join
- Participant must be able to understand and provide informed consent.
- Age 18 years or older at disease onset.
- Definite or probable IIM per the 2017 EULAR/ACR classification criteria.
- Diagnosis of IMNM, meeting the 2016 ENMC classification criteria and having either of the following antibodies:
- Anti-SRP
- Anti-HMGCR
- Early disease as defined as onset of objective muscle weakness assessed by a physician and/or CK elevation attributed to IMNM within 1 year of the time of informed consent.
- Muscle weakness as assessed by an MMT-8 score \ 1.5x ULN along with abnormality in at least 1 of the following 4 CSMs at screening:
- PhGA ≥ 2 cm
- PtGA ≥ 2 cm
- Extramuscular global assessment ≥ 2 cm
- HAQ-DI ≥ 0.25
- Treatment with only one of the following background immunosuppressant medications for IMNM for at least 12 weeks prior to randomization and the same dose for at least 4 weeks prior to randomization:
- Methotrexate up to 25 mg weekly
- Mycophenolate mofetil up to 3000 mg daily
- Mycophenolic acid up to 2160 mg daily
- Azathioprine up to 2.5 mg/kg daily
- Tacrolimus up to 0.2 mg/kg daily
- Cyclosporine up to 5 mg/kg daily
- Current therapy consisting of glucocorticoid ≤ 20 mg/day of prednisone. The dose must be stable for at least 4 weeks prior to randomization. Participants who stopped treatment with glucocorticoids are eligible if the...
- Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control, as shown...
What rules you out
- End-stage myositis with end-organ involvement that poses additional risk to the participant or confounds the assessment of the participant in the study. Conditions include but are not limited to advanced symptomatic...
- Irreversible muscle involvement and/or severe atrophy that will pose additional risk to the participant or confound the assessment of the participant in the study. This includes Muscle Damage VAS ≥ 3 cm at screening...
- Uncontrolled interstitial lung disease or any other uncontrolled IIM manifestation that in the opinion of the investigator would be likely to require treatment with prohibited medication during the study.
- Diagnosis of other inflammatory or noninflammatory myopathies, including antibody-negative IMNM, inclusion body myositis, overlap myositis, metabolic myopathies, muscular dystrophies or family history of muscular...
- Severe liver disease, such as signs of ascites or hepatic encephalopathy.
- History of malignancy (excluding non-melanoma skin cancer) unless cured by adequate treatment, with no evidence of recurrence for ≥ 5 years from the time of informed consent.
- Recent or ongoing bacterial, viral, or fungal infection requiring systemic treatment within 14 days of the time of informed consent.
- Current suppressive therapy for any chronic infections including herpes simplex virus (HSV).
- Infection with Mycobacterium tuberculosis (TB) as defined by any of the following:
- Positive interferon gamma release assay (IGRA) performed at screening or within 12 weeks prior to the time of informed consent.
- Indeterminate IGRAs must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the assay remains indeterminant, a participant must have a negative purified protein derivative...
- Medical history or serologic evidence at screening of chronic infections, including: a. Human immunodeficiency virus (HIV) infection b. Hepatitis B virus (HBV) as indicated by surface antigen or hepatitis B core...
- Known hypersensitivity reaction to ublituximab.
- Received a live or live-attenuated vaccine \< 4 weeks before the time of informed consent. Received any other type of vaccine \< 2 weeks before the time of informed consent.
- Any of the following laboratory tests at screening: a. Hemoglobin \< 10 g/dL b. Absolute white blood cell count \< 3,000 cells/mm3 c. Platelet count \< 100,000 cells/mm3 d. Absolute neutrophils \< 1,500 cell/mm3 e...
- Treatment with any immunosuppressive or immunomodulatory agent, such as cyclophosphamide, biologics, and Janus kinase (JAK) inhibitors, except those listed in the inclusion criteria 7 within 12 weeks prior to...
- Prior receipt of B-cell depleting agents such as rituximab, ocrelizumab, ofatumumab, or belimumab at any time.
- Treatment of IMNM with IVIG or subcutaneous immunoglobulin (SCIG) within 12 weeks of randomization, or prior receipt of more than one cycle of IVIG at any time.
- Participant has current or history (within 12 months of screening) of alcohol, drug, or medication abuse.
- Participant is pregnant or lactating or intends to become pregnant during the study.
- Use of any investigational drug within 24 weeks of the time of informed consent.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Great Neck, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Great Neck, New York, United States and 2 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.