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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01712945
• Date of registration: 19/10/2012
• Prospective Registration: No
• Primary sponsor: Cambridge University Hospitals NHS Foundation Trust
• Public title: Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis CAM-THY
• Scientific title: Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis
• Date of first enrolment: June 2012
• Target sample size: 40
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01712945
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Alasdair Coles, Phd FRCP
• Affiliation: University of Cambridge

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or non-pregnant, non-lactating female patients

- > 18 years of age, and <50 years of age inclusive

- Diagnosis of MS using McDonald's 2010 criteria, including MRI abnormalities consistent
with McDonald's 2010 criteria.

- Onset of first MS symptoms within 10 years on the date the ICF is signed

- EDSS score 0.0 to 5.0 (inclusive) at screening

- At least 2 clinical episodes of MS in the 2 years prior to study entry, with at least
1 attack within 12 months, which may have occurred whilst on disease-modifying
therapy, namely any beta interferon or glatiramer acetate.

- Serum IL-7=7pg/mL

Exclusion Criteria:

- Any progressive form of multiple sclerosis

- Previous thymectomy

- Previous treatment with alemtuzumab, natalizumab, mitoxantrone, cyclophosphomide,
cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than
steroids and disease-modifying therapies listed above)

- History of malignancy

- Personal history of clinically significant autoimmune disease, other than multiple
sclerosis (including but not limited to: thyroid disease, immune cytopenias,
inflammatory bowel disease, diabetes, lupus, severe asthma)

- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis

- Major systemic disease or other illness that would, in the opinion of the
investigator, compromise patient safety or interfere with the interpretation of study
results.

- Seropositivity for human immunodeficiency virus (HIV)

- Past or present hepatitis B infection (positive hepatitis B serology)

- Pregnant women or male and female patients who do not agree to use effective
contraception during the study.

- Medical, psychiatric, cognitive or other conditions that, in the investigator's
opinion, compromise the patient's ability to understand the patient information, to
give informed consent, to comply with the trial protocol, or to complete the study.



Age minimum: 18 Months
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Palifermin

Drug: Alemtuzumab

Primary Outcome(s)

incidence of clinical autoimmunity [Time Frame: within 30 months of starting treatment with alemtuzumab]

Secondary Outcome(s)

Absolute numbers of naive T cells [Time Frame: within 30 months of starting treatment with alemtuzumab]

Safety events [Time Frame: within 30 months of starting treatment with alemtuzumab]

Secondary ID(s)

EudraCT 2011-005606-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors