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.
  

MINORE (22-0386)

• Investigator: Dr. Anna Shah
• Purpose: to understand the potential effect of ocrelizumab on babies born to women with MS or CIS who received the drug up to six months before they became pregnant, or in the first three months (the first trimester) of their pregnancy.
• Timeline: up to 7 visits (2 for the baby & 5 for the mother) between week 24 of your pregnancy and until your baby reaches 13 months of age.
• ClinicalTrials.gov Identifier: NCT04998812
• Key Eligibility Criteria: age: 18-40 years old, diagnosis: MS or clinically isolated syndrome (CIS), currently pregnant at 24-30 gestational weeks, last exposure to ocrelizumab up to 6 months before last menstrual period.
  

SOPRANINO (22-0387)

• Investigator: Dr. Anna Shah
• Purpose: to understand whether ocrelizumab is transferred to the breast milk of women MS or CIS who are being treated with ocrelizumab, and if it is, what effect this has on babies who are breastfed.
• Timeline: up to 5 study visits (3 for the mother & 2 for the baby) over approximately 16 months.
• ClinicalTrials.gov Identifier: NCT04998851
• Key Eligibility Criteria: age: 18-40 years old, diagnosis: MS or clinically isolated syndrome (CIS), woman with infant between 2-24 weeks old, planning to receive ocrelizumab infusion within 24 weeks of birth, currently breastfeeding or planning to breastfeed.
  

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