NCT06310343

ADAs to Alemtuzumab

A Study of a New Assay to Detect Anti-drug Antibodies to Alemtuzumab and Their Potential Impact in Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period

Detailed description

Primary To quantify the longitudinal changes in alemtuzumab ADAs over a 24 month period. Secondary 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2. 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions. 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity. 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels. 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Alemtuzumab	Licensed dose

Timeline

• Start date: 2022-07-12
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2024-03-15
• Last updated: 2026-03-02

Locations

1 site across 1 country: United Kingdom