NEUROIMMUNOLOGY (MS) RESEARCH

CIELO (22-0449)

•  Investigator: Amanda Piquet, MD
• Purpose: to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of an investigational drug in patients with anti N-methyl-D-aspartic acid receptor (NMDAR) or anti leucine-rich glioma-inactivated 1 (LGI1) encephalitis.
• Intervention: Investigational drug (50% chance) vs. placebo (50% chance)
• Timeline: screening period
  • Part 1: primary interventional period of 52 weeks
  • Part 2: an optional extension period lasting ~2 years
    • Option 1: continue on randomized, double-blind investigational drug or placebo
    • Option 2: start open-label investigational drug
    • Option 3: stop investigational drug or placebo and continue follow-up assessments within Part 2
• ClinicalTrials.gov Identifier: NCT05503264
• Key Eligibility Criteria:
  • Onset of autoimmune encephalitis symptoms less than or equal to 9 months before randomization
  • Reasonable exclusion of tumor or malignancy
  • NMDAR Cohort:
    • Age: 12 and older
    • Diagnosis of probable or definite NMDAR encephalitis
  • LGI1 Cohort:
    • Age: 18 and older
    • Diagnosis of LGI1 encephalitis

Rocky Mountain MS Center (RMMSC) Biorepository for the Study of Neuroimmunological Disorders (12-0968)

DREAMS (19-0393)   

• Investigator: Teri Schreiner, MD, MPH  
• Purpose: to learn more about the risk factors for and causes of MS by studying children who are first degree relatives of people with MS.
• Timeline: a single 3-4 hour study visit (includes MRI and blood draw).
• Key Eligibility Criteria:
  • Age 10-17 years old
  • Have parent or sibling with MS
  • No diagnosis of MS or early symptoms of MS

RISE-MS (17-1884)   

• Investigator: Enrique Alvarez, MD, PhD and John Corboy, MD 
• Purpose: to learn more about the risk factors for and causes of MS by studying first degree relatives of people with MS  
• Timeline: a single 2-3 hour study visit (includes MRI and blood draw).
• ClinicalTrials.gov Identifier: NCT03586986 
• Key Eligibility Criteria:
  • Age 18-30 years old
  • Have parent or sibling with MS
  • No diagnosis of MS or early symptoms of MS
    

Currently Enrolling Studies

BEAT-MS (19-1621)

• Investigator: John Corboy, MD 
• Purpose: to compare efficacy and safety of autologous hematopoietic stem cell transplantation (AHSCT) to best available therapy (BAT) in treatment resistant relapsing MS. 
• Intervention: best available therapy (50% chance) or AHSCT cell transplant (50% chance).
• Timeline: up to 17 study visits over 6 years (not including stem cell transplantation procedures, if randomized to AHSCT group).
• ClinicalTrials.gov Identifier: NCT04047628 
• Key Eligibility Criteria:
  • Age 18-55 years old
  • Diagnosis: highly active, treatment resistant MS
  • 2 clinically confirmed episodes of treatment failure in the past 36 months
  • Insurance or public funding available to cover the cost of an MS DMT
    

De-Escalation Study (21-4993)

• Investigator: Enrique Alvarez, MD, PhD
• Purpose: to learn more about how “de-escalation” therapy affects outcomes in patients with relapsing forms of multiple sclerosis (MS).  “De-escalation” means switching from an anti-CD20 treatment to Vumerity or Tecfidera.
• Timeline: 6 in-person visits over 24 months.
• Key Eligibility Criteria:
  • Age: 18+ years old
  • Diagnosis: relapsing MS
  • Taking an anti-CD20 (Ocrevus, Rituxan) for at least 1 year
  • Planning to initiate Vumerity or Tecfidera treatment
    

DELIVER-MS (18-1633)

• Investigator: Enrique Alvarez, MD, PhD
• Purpose: to learn whether there is a difference between two common treatment approaches for people who have recently been diagnosed with relapsing remitting MS: escalation approach (start out by using a lower-risk, moderately effective medication) vs early highly effective treatment approach (start out with one of the stronger, but potentially more risky, medications).
• Timeline: 13 study visits over 3 years.
• ClinicalTrials.gov Identifier: NCT03535298
• Key Eligibility Criteria:
  • Age: 18-60 years old
  • Recently diagnosed with MS
  • Not currently taking any MS medication (but plan to start one soon)
    

FUSION (22-2421)

• Investigator: Enrique Alvarez, MD, PhD
• Purpose:
  • Part 1: to find out how safe and effective a investigational drug called BIIB091 is when given to people with RMS, and how well the body can handle taking it (tolerability).
  • Part 2: to know whether a specific dose of the investigational drug (BIIB091) works and whether it is safe for people with relapsing forms of multiple sclerosis or “RMS” when given with DRF.
• Intervention: BIIB091 or DRF or a combination of both.
• Timeline: The study will be done in 2 parts: Part 1 and Part 2. The participant will only be invited to participate in one part. Regardless of part, there will be 3 different periods:
  • Screening period – up to 4 weeks
  • Study treatment period – about 48 weeks
  • Follow-up period – about 2 weeks
• ClinicalTrials.gov Identifier: NCT05798520
• Key Eligibility Criteria:
  • Age:18-55 years old (inclusive) at the time of informed consent
  • Diagnosis: Relapsing Remitting Multiple Sclerosis (RRMS) or active Secondary-Progressive Multiple Sclerosis (SPMS)
  • Time since MS symptom onset is  <20 years
    

REMODEL 2 (21-4825)

•  Investigator: Enrique Alvarez, PhD, MD
• Purpose: to provide efficacy, safety and tolerability data for an investigational drug to support regulatory approval worldwide as a treatment for RMS.
• Intervention: Investigational drug and placebo (50% chance) -or– an approved drug and placebo (50% chance).
• Timeline: 15 in-person visits for up to 2.5 years followed by an Open Label Extension (OLE) which involves 13 in-person visits for up to 5 years.
• ClinicalTrials.gov Identifier: NCT05156281
• Key Eligibility Criteria:
  • Age: 18-55
  • Diagnosis: RRMS
  • 1 documented relapse in previous year OR 2 documented relapses in previous 2 years OR 1 active Gd-enhancing lesion in past year
  • Neurologically stable within 1 month