NCT05906992

Brief Summary

This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for phase_3

Timeline
33mo left

Started Jan 2024

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Jan 2029

First Submitted

Initial submission to the registry

May 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 11, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

3.1 years

First QC Date

May 9, 2023

Last Update Submit

May 20, 2024

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve in PK group

    To demonstrate PK comparability in terms of the area under the concentration time curve in patients with RRMS as follows: * Area under the concentration-time curve from time zero to Week 2 (AUC0-wk2) * Area under the concentration-time curve from Week 2 to Week 24 (AUCwk2-wk24)

    Up to Week 24

  • Total number of new GdE lesions on T1-weighted brain MRI in Main study group

    To demonstrate the equivalence of CT-P53 to reference drug (EU-Ocrevus and US-Ocrevus) in terms of efficacy in patients with RRMS as determined by the total number of new gadolinium-enhancing (GdE) lesions on T1-weighted brain magnetic resonance imaging (MRI)

    Up to Week 24

Secondary Outcomes (12)

  • Absoulte CD19+ B-cell counts for PD assessments

    Up to Week 96

  • Area under the concentration-time curve in PK group

    Up to Week 16

  • Total body clearance in PK group

    Up to Week 2

  • Volume of distribution at steady state in PK group

    Up to Week 2

  • Safety: Immunogenecity

    Up to Week 96

  • +7 more secondary outcomes

Study Arms (3)

CT-P53

EXPERIMENTAL

CT-P53(Ocrelizumab)

Biological: CT-P53

US-Ocrevus

ACTIVE COMPARATOR

US-licensed Ocrevus(Ocrelizumab)

Biological: US-Ocrevus

EU-Ocrevus

ACTIVE COMPARATOR

EU-approved Ocrevus(Ocrelizumab)

Biological: EU-Ocrevus

Interventions

CT-P53BIOLOGICAL

Intravenous(IV) infusion

Also known as: Ocrelizumab
CT-P53
US-OcrevusBIOLOGICAL

Intravenous(IV) infusion

Also known as: Ocrelizumab
US-Ocrevus
EU-OcrevusBIOLOGICAL

Intravenous(IV) infusion

Also known as: Ocrelizumab
EU-Ocrevus

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.
  • Patient has evidence of recent MS activity as defined in the study protocol
  • Patient has neurological stability for ≥30 days.
  • Patient with 0 to 6.0 (both inclusive) on the EDSS score.

You may not qualify if:

  • Patient diagnosed with primary or secondary progressive MS.
  • Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
  • Patient unable to complete or has a contraindication to an MRI
  • Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
  • Patient who has currently or history of any of medical conditions described in the study protocol.
  • Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CT-P53 3.1 investigational site

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Minji Ma

    Celltrion, Inc.

    STUDY CHAIR

Central Study Contacts

SoYoung Yoo

CONTACT

+82 32 850 5791soyoung.yoo@celltrion.com

JinHo Lee

CONTACT

+82 32 850 5787jinho.lee2@celltrion.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 18, 2023

Study Start

January 11, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

January 1, 2029

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

PL(1)