Recruiting PHASE2 Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE)

New treatment option for Anti-N-methyl-D-aspartate Receptor (NMDAR) Encephalitis (ANRE)

Official title A Study in Participants With Anti-NMDAR Encephalitis and Anti-NMDAR Autoantibody-Associated Psychiatric Disease

ClinicalTrials.gov ID: NCT07093333

What this study is testing

What is ART5803?

ART5803 is an investigational medicine, being studied as a potential treatment for anti-n-methyl-d-aspartate receptor (nmdar) encephalitis (anre).

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 study will evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics (PK) of ART5803 in adult participants with a confirmed diagnosis of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis (ANRE) or anti-NMDAR autoantibody-associated psychiatric disease
  • 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

  • 7.3.1 Individuals in Cohort A (participants with chronic ANRE) must meet all of the study in Section 7.3.1.1. Individuals enrolled in Cohort B or...
  • Eligibility for participation in this study will be determined solely based on the participant meeting all protocol-defined inclusion and

You likely can't join if

  • . The legally authorized representative (LAR), where applicable, may provide informed consent on behalf of a participant who lacks the capacity to...
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of...
  • The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the...
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the...
  • The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset \>9 months to ≤36 months (or...
  • The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months of Week 0, Day 0. Participants without a...
See the full eligibility criteria
Who can join
  • 7.3.1 Individuals in Cohort A (participants with chronic ANRE) must meet all of the study in Section 7.3.1.1. Individuals enrolled in Cohort B or Cohort C (participants with subacute or acute ANRE) must meet all of the...
  • Eligibility for participation in this study will be determined solely based on the participant meeting all protocol-defined inclusion and
What rules you out
  • . The legally authorized representative (LAR), where applicable, may provide informed consent on behalf of a participant who lacks the capacity to provide consent in accordance with local regulations; however, the LAR...
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19...
  • The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related...
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset \>9 months to ≤36 months (or ≤120 months with Sponsor approval) prior to Week 0, Day 0.
  • The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months of Week 0, Day 0. Participants without a positive CSF anti-NMDAR IgG autoantibody result within 9 months of Week...
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Participants who are taking psychiatric medications (anti-depressants and antipsychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first 6...
  • Adequate disease burden as defined as any one of the following (a to c) at Screening and Week 0, Day 0: a. Two of the following: i. WAIS-IV immediate recall score \ 40 seconds iii. RAVLT score \<7 b. BDI-II total score...
  • No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers). Note: Discovery...
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study...
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include...
  • Male participants must agree not to donate sperm, and female participants must agree not to donate eggs from the first study drug administration and until at least 90 days after the last dose of the study drug, or...
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study. 7.3.1.2 Cohort B and Cohort C Inclusion Criteria The criteria below must be applied to all participants screened for...
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19...
  • The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who...
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset ≥4 months and ≤9 months (Cohort B) or ≥0 months and \<4 months (Cohort C) prior to Week 0, Day 0.
  • Participants with ANRE symptoms as assessed by the mRS with a score of ≥3 during Screening and Week 0, Day 0.
  • The participant has a positive cell-based assay result for CSF anti-NMDAR IgG autoantibody within 9 months for Cohort B and 4 months for Cohort C prior to Week 0, Day 0. Participants without a positive CSF anti-NMDAR...
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Immunotherapy:
  • Cohort B: Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Cohort C: Participants may receive ART5803 regardless of previous or ongoing immunotherapy treatment status (per the Investigator's discretion).
  • Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first...
  • Participants treated with plasmapheresis must have completed treatment at least 1 day prior to Week 0, Day 0.
  • Participants receiving steroids must be on a stable dose or a predefined taper regimen for at least 2 weeks prior to Week 0, Day 0.
  • No active malignancy (see Section 7.6.3.3) or residual teratoma. Prior teratoma must be fully resected ≥1 week before Week 0, Day 0 with no evidence of recurrence per work-up (imaging and tumor markers). Note: Discovery...
  • Participants must have undergone appropriate cancer screening prior to study enrollment. The specific series of investigations used for each participant will occur according to the judgment of the treating Investigator...
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study...
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include...
  • Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or...
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study. 7.3.1.3 Cohort D Inclusion Criteria The criteria below must be applied to all participants screened for Cohort D...
  • The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19...
  • The participant, or their LAR, must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who...
  • The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
  • The participant has persistent psychotic symptoms for at least 2 months prior to Screening and Week 0, Day 0 as evaluated by the Investigator.
  • The participant has marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
  • The participant has the documented presence of:
  • Anti-NMDAR autoantibodies in CSF within 6 months of Week 0, Day 0; or
  • Positive CSF anti-NMDAR autoantibody within 12 months of Week 0, Day 0 and positive serum anti-NMDAR autoantibody during Screening (see Section 7.6.4.6.1).
  • Participants treated with IVIG must have completed treatment at least 7 days prior to Week 0, Day 0.
  • Participants previously treated with immunotherapy must be receiving a stable dose (per Investigator discretion) for ≥1 month before Week 0, Day 0.
  • Participants who are taking psychiatric medications (anti-depressants and anti psychotics) must remain on stable background psychiatric medications for at least 4 weeks prior to Week 0, Day 0 and for at least the first...
  • Adequate disease burden as defined as both of the following: a. Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥70 and a PANSS item score ≥4 (moderate) on 2 or more of the following...
  • Sexually active female participants of childbearing potential and male participants with female partner(s) of childbearing potential must be willing to use a highly effective method of contraception during the study...
  • Female participants of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include...
  • Male participants must agree not to donate sperm and female participants must agree not to donate eggs, from the first study drug administration and until at least 90 days after the last dose of the study drug, or...
  • Compliance with these restrictions must be documented at Screening and confirmed throughout the study. 7.3.2 Exclusion Criteria Individuals (Cohorts A, B, C, or D) will not be eligible to participate in the study if...
  • The participant is pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time during the study.
  • The participant has used an investigational product (IP) or investigational medical device within 30 days or 5 half-lives of the other IP (whichever is longer) prior to Screening or is required to use any...
  • The participant has used an NMDAR modulator other than the study drug (e.g., ketamine, memantine, dextromethorphan, amantadine, ifenprodil, phencyclidine, acamprosate, D-cycloserine) from within 5 half-lives of the...
  • The participant has previous exposure to ART5803 or other antibody that targets NMDAR.
  • Participant has 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...
  • Participant with coexisting CNS demyelinating disorders (e.g., multiple sclerosis), known positivity to other autoantibodies associated with autoimmune encephalitis, or any significant history of a psychiatric or...
  • The participant has a confirmed positive test for hepatitis B serology (hepatitis B surface antigen and core antigen) and/or hepatitis C polymerase chain reaction at Screening.
  • The participant has a known history of allergy or reaction to any component of the investigational agent (ART5803), or history of anaphylaxis following any biologic therapy.
  • The participant has a history (within 12 months prior to Screening for Cohorts A, B, or C) or current (for Cohort D) alcohol abuse or drug addiction, defined as moderate or severe substance use disorder per Diagnostic...

The study team makes the final eligibility decision.

Where it's taking place

  • Seoul, South Korea

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 Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.

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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.