Date: 2012-03-12
Type of information:
phase: 3
Announcement: results
Company: Basilea Pharmaceutica (Switzerland)
Product: oral alitretinoin
Action mechanism:
Disease: severe chronic hand eczema
Therapeutic area: Dermatological diseases
Country: USA
Trial
details: The HANDEL study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo. In this randomized, double-blind, placebo-controlled multicenter study, 596 adult patients with severe chronic hand eczema unresponsive to potent topical corticosteroids were randomized either to a once-daily dose of 30 mg alitretinoin or placebo for a treatment duration of up to six months. Since alitretinoin belongs to a pharmaceutical class that is known to be teratogenic and contraindicated in pregnancy, strict pregnancy risk management measures were required for women of childbearing potential who participated in the study. Patients included in the study had a long history of disease, for an average of seven years, and had a pre-treatment run-in period of up to four months to confirm the refractory nature of the disease towards potent topical corticosteroids. Patients are being followed for twelve months post treatment in total to assess sustainability of response and safety.
(http://www.clinicaltrials.gov/ct2/show/NCT00817063)
Latest
news: Basilea Pharmaceutica has announced topline results from its U.S. phase III HANDEL study with its investigational compound oral alitretinoin in severe chronic hand eczema (CHE) refractory to potent topical corticosteroids. The results cover observations made during the treatment period and the first six-month post-treatment observation period.
Basilea\'s U.S. phase III HANDEL study with investigational compound oral alitretinoin meets study endpoints. At the end of treatment, 40% of patients treated with alitretinoin achieved \"clear\" or \"almost clear\" hands compared to 15% treated with placebo (p<0.001) based on the primary outcome measure Physician Global Assessment (PGA) in the intent-to-treat population, thereby achieving the primary study objective.
Consistent with the physicians\' assessment, the secondary outcome measure of the Patient\'s Global Assessment (PaGA) demonstrated that 39% of patients treated with alitretinoin scored themselves as \"cleared\" or \"almost cleared\", compared to 14% of patients treated with placebo (p<0.001). In another secondary measure of treatment effect, the modified Total Lesion Symptom Score (mTLSS), the mean reduction in score values was 54% in patients treated with alitretinoin compared to 30% for patients treated with placebo (p<0.001).
Analysis of the topline data indicates that alitretinoin exhibited a safety profile consistent with that reported in previously conducted clinical studies. During therapy the most common adverse events considered as related to alitretinoin were headache, followed by flushing, nausea and increased blood triglycerides.
End-of-treatment data and currently available 12-month follow-up data did not show an impact of alitretinoin on bone mineral density. Final bone mineral density analyses will be performed after completion of the one-year post-treatment observation period. These data are expected to be available around mid-year.
Dr. Anthony Man, Chief Executive Officer of Basilea Pharmaceutica International Ltd., said, \"This is an important development milestone for alitretinoin. The topline results of this large prospective randomized trial in patients in the U.S. are consistent with previous randomized international studies. We plan to discuss the final study results and the requirements for a risk evaluation and mitigation strategy (REMS) with the FDA in the second half of 2012 in the context of a potential filing of a New Drug Application in the U.S.\"
