Safety and Efficacy of Tocilizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

NCT06452537 | Active Not Recruiting Phase 2

• 1 other identifier: 2024035
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of Tocilizumab in MOGAD.

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Outcome Measures

Primary Outcomes (1)

• Time from randomization to the first MOGAD relapse as determined by an adjudication committee

  An adjudicated relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.

  Baseline, Up To 60 Weeks (End of Study)

Secondary Outcomes (6)

• Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study

  Baseline, Up To 60 Weeks (End of Study)

• Dosage of oral steroid at the end of the TOMATO trial

  Baseline, Up To 60 Weeks (End of Study)

• Sera MOG-IgG Concentration Over Time

  Baseline, Weeks 12, 24, 36, 48, 60 Weeks (End of Study)

• Number of Participants With Adverse Events (AEs)

  Baseline, Up To 60 Weeks (End of Study)

• Number of Participants With Adverse Events Serious Adverse Events (SAEs)

  Baseline, Up To 60 Weeks (End of Study)

Study Arms (2)

Tocilizumab with oral prednisone

EXPERIMENTAL

Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone

Drug: Tocilizumab; Drug: Prednisone

Prednisone

EXPERIMENTAL

Drug: Prednisone

Interventions

Tocilizumab DRUG

Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, with oral prednisone.

Also known as: ACTEMRA®

Tocilizumab with oral prednisone

Prednisone DRUG

Prednisone tapering protocol : If the starting dose is over 20mg/day, then reduce by one tablet weekly. Until the dose is reduced to 20mg/day then 20mg/day for two weeks→17.5mg/day for two weeks→12.5mg for four weeks→10mg for four weeks→7.5mg as a maintain dosage

Prednisone; Tocilizumab with oral prednisone

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are aged ≥12 years at the time of signing Informed Consent Form
• Confirmed diagnosis of MOGAD with a history of ≥1 MOGAD relapse in the 12 months prior to screening or ≥2 attacks in the 24 months prior to screening
• Anti-MOG antibody seropositive
• For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of tocilizumab
• Patients must give written informed consent

You may not qualify if:

• Any concomitant disease other than MOGAD that may require treatment with oral immunosuppressants or prednisone at doses \>20 mg/day (or equivalent)
• Receipt of the following at any time prior to randomization Alemtuzumab Total lymphoid irradiation Bone marrow transplant T-cell vaccination therapy Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
• Receipt of intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 1 month prior to randomization.
• Receipt of any of the following within 3 months prior to randomization:
• Natalizumab (Tysabri®). Methotrexate Mitoxantrone Cyclophosphamide Eculizumab
• Receipt of any of the following within 6 weeks prior to randomization:
• Tacrolimus Cyclosporin Mycophenolate mofetil
• Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of tocilizumab
• Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
• Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
• Participants with positive screening tests for hepatitis B and C
• Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
• Known history of a severe allergy or reaction to any biologic therapy.
• History of alcohol, drug, or chemical abuse, or a recent history of such abuse \< 1 year prior to randomization
• WBC \< 3.0 × 10\^3/mL, ANC \< 2.0 × 10\^3/mL, PLT \< 10 × 10\^4/mL, AST or ALT\>1.5 ×ULN, Lymphocyte count \< 0.5 × 10\^3/mL

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (22)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 73000, China

Location

Hebei Children's Hospital

Shijiazhuang, Hebei, 050000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, China

Location

Ordos Central Hospital

Ordos, Inner Mongolia, 017000, China

Location

The Third Affiliated Hospital of Soochow University

Changzhou, Jiangsu, 213000, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215025, China

Location

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 751705, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, 830001, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100000, China

Location

China-Japan Friendship Hospital

Beijing, 100000, China

Location

Chinese PLA General Hospital

Beijing, 100000, China

Location

The First Affiliated Hospital of Tsinghua University

Beijing, 100000, China

Location

XuanWu Hospital Capital Medical University

Beijing, 100000, China

Location

Huashan Hospital, Fudan University

Shanghai, 200000, China

Location

Tianjin Huanhu Hospital

Tianjin, 300052, China

Location

Tianjin Children's Hospital

Tianjin, 30052, China

Location

MeSH Terms

Conditions

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Interventions

tocilizumab; Prednisone

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chao Zhang, M.D., Ph.D

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: July 9, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22)