BridgeMD
New treatment option for Autoimmune Encephalitis
Official title The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
ClinicalTrials.gov ID: NCT04372615
What this study is testing
What is Inebilizumab?
Inebilizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for autoimmune encephalitis.
Also referred to as UPLIZNA.
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
- Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.
- 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 12 and older
You may be able to join if
- Diagnosis of NMDAR encephalitis, defined by both a and b:
- A subacute onset of change in mental status consistent with autoimmune encephalitis,
- A positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories.
- Participants, ≥ 12 years of age at the time of informed consent. Participants under 18 years of age must weigh ≥40 kilograms.
- Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United...
You likely can't join if
- Any of the following excludes an individual from participation in the study:
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of...
- Presence of an active or chronic infection that is serious in the opinion of the Investigator.
- History of solid organ or cell-based transplantation.
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the...
- Lactating or pregnant individuals, or individuals who intend to become pregnant anytime from study enrollment to 12 months following last dose of...
See the full eligibility criteria
Who can join
- Diagnosis of NMDAR encephalitis, defined by both a and b:
- A subacute onset of change in mental status consistent with autoimmune encephalitis,
- A positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories.
- Participants, ≥ 12 years of age at the time of informed consent. Participants under 18 years of age must weigh ≥40 kilograms.
- Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the...
- Non-sterilized participants who are sexually active with a partner capable of becoming pregnant must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such...
- Participants of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (per ICH...
- A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Periodic abstinence, the rhythm method, and the...
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system, also known as drug-eluting IUD a
- Bilateral tubal occlusion
- Vasectomized partner b
- Sexual abstinence c Combined (estrogen and progestogen-containing hormonal contraception)
- Oral (combined pill)
- Injectable
- Transdermal (patch)
- Progestogen-only hormonal contraception associated with inhibition of ovulation d
- Implantable
- Intravaginal a This is also considered to be a hormonal method. b With appropriate post-vasectomy documentation of surgical success (absence of sperm in ejaculate). c Sexual abstinence is considered to be a highly...
- Willing to forgo other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study.
- Participant must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 90 days prior to randomization (Day 1). In addition, participants must have received EITHER of the...
- IVIg, at a dose range between 1.2 and 2 g/kg
- Plasma exchange or plasmapheresis, (defined as 5 to 6 exchanges). NOTE: These treatments may be provided during the screening period but must be completed prior to randomization. Participants who receive...
- Modified Rankin Score of ≥3 at the screening visit, indicating at least moderate disability. The baseline mRS must be confirmed by Site Investigators at screening and confirmed / adjudicated before randomization.
- Ability and willingness to attend study visits and complete the study. \ All must be met during the screening period, prior to randomization, except where noted.
What rules you out
- Any of the following excludes an individual from participation in the study:
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, interpretation of participant safety or study results, or would make participation in the study an...
- Presence of an active or chronic infection that is serious in the opinion of the Investigator.
- History of solid organ or cell-based transplantation.
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is longer, prior to randomization.
- Lactating or pregnant individuals, or individuals who intend to become pregnant anytime from study enrollment to 12 months following last dose of investigational agent.
- Known history of allergy or reaction to any component of the investigational agent formulation or history of anaphylaxis following any biologic therapy.
- Receipt of the following at any time prior to randomization: a. Alemtuzumab b. Total lymphoid irradiation c. Bone marrow transplant d. T-cell vaccination therapy
- Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening. Receipt of such a B cell-depleting agent in the period 6-12...
- Treatment at therapeutic doses/durations with any of the following within 3 months prior to randomization a. Natalizumab (Tysabri®) b. Cyclosporine c. Methotrexate d. Mitoxantrone e. Cyclophosphamide\ f. Azathioprine g...
- Severe drug allergic history or anaphylaxis to two or more food products or medicines (including known sensitivity to acetaminophen/paracetamol, diphenhydramine (cetirizine in EU) or equivalent antihistamine, and...
- Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infection.
- Active malignancy or history of malignancy that was active within the last 10 years, apart from ovarian or extra-ovarian teratoma (also known as a dermoid cyst) or germ cell tumor, or squamous cell carcinoma of the skin...
- At screening (repeat testing may be conducted to confirm results within the same screening period, prior to randomization), any of the following: a. Total white blood count \<2,500 cells/mm3 (or \< 2.5 × 109/L) b. Total...
- Active hepatitis B or C established with positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR testing and confirmed by the MSM
- Any live or attenuated vaccine within 4 weeks prior to Day 1 (administration of killed vaccines is acceptable).
- Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of enrollment.
- History of alcohol or drug abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits or interfere with safety or other study assessments.
- Recurrence of previously treated NMDAR encephalitis within the last 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening.
- Evidence of active tuberculosis\ (TB) or being at high risk for TB based on: a. History of active TB or untreated/incompletely treated latent TB. Participants with a history of active or latent TB who have documentation...
- Active, clinically significant (CS) infection at the time of randomization (IP administration may be delayed until recovery, if within 14-day screening window, otherwise participant may be rescreened). Exclusion...
- Participants will undergo QuantiFERON®-TB Gold testing or equivalent TB testing during screening as standard of care. A positive result will not exclude patients from participation; thus, enrollment should not be...
- At screening (out of range lab values may be reviewed with the MSM to determine whether a potential participant should be excluded for safety reasons; repeat testing may be conducted to confirm results within the same...
- Aspartate transaminase (AST) \> 2.5 × age-based upper limit of normal (ULN)
- Alanine transaminase (ALT) \> 2.5 × age-based ULN
- Total bilirubin \> 1.5 × age-based ULN (unless due to Gilbert's syndrome)
- Platelet count \< 75,000/μL (or \< 75 × 109/L)
- Hemoglobin \< 8 g/dL (or \< 80 g/L or 5 mmol/L)
- History of untreated hepatitis C infection. Participants who are considered cured following antiviral therapy with an HCV load below the limit of detection may be enrolled pending confirmation from the MSM that there...
- Patients with coexistent autoantibodies should not immediately be excluded but should be reviewed with the MSM to determine eligibility.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Orange, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Williamsville, New York, United States
+ 13 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Orange, California, United States; Sacramento, California, United States; Aurora, Colorado, United States and 27 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.