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Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

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Overview Studies Clinical Trials

Terminated PHASE1, PHASE2 INTERVENTIONAL NCT01712945

Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to test a novel strategy to prevent the clinical problem of secondary autoimmunity following alemtuzumab treatment of multiple sclerosis. The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that promotes thymic T cell regeneration (Palifermin, Kepivance®).

Detailed Description

This is a single-centre, double-blinded, randomised controlled trial of palifermin (Kepivance) vs. placebo in the prevention of autoimmunity following alemtuzumab treatment of multiple sclerosis. The dose of palifermin (kepivance)used in this trial will be informed by a dose-escalation study.

Interventions

Name: Palifermin

Type: DRUG

Description: Palifermin (Kepivance®) administered by intravenous bolus on days -5, -4. -3 prior to, and on days 8, 9 and 10 after each cycle of alemtuzumab, then again on 3 consecutive days at month 1 and month 3 after each cycle of alemtuzumab. Patients will be observed for adverse reactions for at least 1 to 2 hours following each bolus dose.

Name: Alemtuzumab

Type: DRUG

Description: Initial treatment alemtuzumab will be administered as a fixed total dose of 60 mg IV over 5 consecutive days (12mg/day). For re-treatment at Month 12, alemtuzumab will be administered as a fixed total dose of 36mg IV over 3 consecutive days (12mg/day).

Primary Outcomes

Measure: incidence of clinical autoimmunity

TimeFrame: within 30 months of starting treatment with alemtuzumab

Description: The primary endpoint is incidence of clinical autoimmunity within 30 months of starting treatment with alemtuzumab

Trial Information

NCT ID

NCT01712945

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Last Updated

December 15, 2025