Phase II Clinical Trial of OCH-NCNP1

Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis

This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary progressive mltiple sclerosis (SPMS) .

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive
• Intervention / Treatment: Drug: OCH-NCNP1; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 187-8551
    • National Center of Neurology and Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria:

  1. Provision of written informed consent to participate in this study
  2. Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017
  3. Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment
  4. Have at least one T2 lesion on MRI scans at screening
  5. EDSS less than or equal to 7
  6. 20 =< Age < 65
  7. Promise to prevent conception for at least 90 days after the last administration
  8. Neurological stability has been confirmed by a neurologist

Exclusion Criteria:

• Subject with MS patients meeting any of the following criteria must not be enrolled in the study:

  1. Diagnosed as Neuromyelitis Optica
  2. Women who are pregnant or lactating
  3. Patients who is prohibited MRI
  4. Patients who are allergic to Gd-contrast medium
  5. History of liver diseases or liver transplantation
  6. Liver dysfunction in the screening test and baseline physical examination
  7. History of cancer past five years
  8. Negative for herpes zoster virus antibody
  9. Positive for Syphilis serum reaction
  10. Positive for Beta-glucan or positive for T-spot
  11. Positive for Anti-Aquaporin 4 antibody
  12. History of HIV infection
  13. History of HBV or HCV infection
  14. History of Transplantation
  15. Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication.
  16. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication
  17. Lymphocyte number < 600 /mm3 in peripheral blood
  18. Current diagnosed or suspected infectious diseases
  19. Compromised Patients
  20. Inflammatory Bowel disease
  21. Subjects with prolongation of QT/QTc interval
  22. History or have risk of torsade de pointes
  23. Taking the medicine which has risk of prolongation of QT/QTc interval
  24. History of severe allergy of medicine or food
  25. History or current of drug/ alcohol addiction
  26. Bronchial Asthma
  27. Epilepsy Other protocol-defined exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo is supplied as granules and take orally once a week.
Active Comparator: OCH-NCNP1 3 mg	Drug: OCH-NCNP1; OCH-NCNP1 3mg is supplied as granules and take orally once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline	Change from screening at Month 6.

Secondary Outcome Measures

Outcome Measure	Time Frame
annual relapse rate	Month 6
Detection of asymptomatic	Month 6
Expanded Disability Status Scale (EDSS) / Functional Scale (FS)	screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks
Duration of sustained reduction in disability (SRD)	Month 6
Change of MRI	Change from screening at Month 3 and 6
Change of No evidence of disease activity (NEDA)	Change from screening at Month 3 and 6

Collaborators and Investigators

• Sponsor: National Center of Neurology and Psychiatry, Japan
• Investigators: Principal Investigator: Tomoko Okamoto, MD, National Center of Neurology and Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: OCH-NCNP1-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No