Know Cancer

forgot password

Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis

Phase 1/Phase 2
18 Months
50 Years
Open (Enrolling)
Multiple Sclerosis

Thank you

Trial Information

Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

incidence of clinical autoimmunity

Outcome Description:

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

Outcome Time Frame:

within 30 months of starting treatment with alemtuzumab

Safety Issue:


Principal Investigator

Alasdair Coles, Phd FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cambridge


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

EudraCT 2011-005606-30



Start Date:

June 2012

Completion Date:

October 2017

Related Keywords:

  • Multiple Sclerosis
  • Alemtuzumab
  • Palifermin
  • Reconstitution
  • Thymus
  • Multiple Sclerosis
  • Sclerosis