NCT06952413

Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

An Exploratory, Placebo-controlled, Double-blind, Phase II Study of the Efficacy and Safety for Rituximab (Genetical Recombination) in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Center of Neurology and Psychiatry, Japan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The efficacy and safety of rituximab on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.

Detailed description

The efficacy and safety of rituximab (genetical recombination), a CD20 antibody, on ME/CFS symptoms after administration to patients with myalgic encephalomyelitis/chronic fatigue syndrome will be compared in an exploratory, placebo-controlled, double-blind fashion. In the subsequent secondary evaluation period, subjects who received rituximab in the primary evaluation period will receive placebo, and the timing and duration of rituximab's effect will be explored throughout the entire evaluation period. Subjects who received placebo during the primary evaluation period will receive rituximab during the secondary evaluation period to explore changes in endpoints before and after switching from placebo to rituximab in the same subjects.

Conditions

• Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Interventions

Type	Name	Description
DRUG	Rituximab(Genetical Recombination)	Subjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.
DRUG	Placebo	Subjects will be assigned to the rituximab pre-treatment group or placebo pre-treatment group and will receive the study drug (rituximab actual or rituximab placebo) intravenously four times at weekly intervals during the first three weeks of the primary and secondary evaluation periods.

Timeline

• Start date: 2025-04-09
• Primary completion: 2026-09-30
• Completion: 2027-10-31
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: Japan