A DOUBLE-BLIND, 4-BLOCK RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE PHASE 2/3 TRIAL TO CONFIRM EFFICACY OF BLS-ILB-E710C IN PATIENTS WITH CERVICAL INTRAEPITHELIAL NEOPLASIA 2/3 WITH EXTENSION STUDY

초록

Objectives Current treatments for cervical intraepithelial neoplasia 2/3(CIN 2/3) are ablative, so non-invasive treatments are needed as alternatives. For the development of alternative treatment, we designed adaptive phase 2/3 trial to confirm efficacy of BLS-ILB-E710c in patients with CIN 2/3. Methods Safety and efficacy of BLS-ILB-E710c are assessed in a double-blind, 4-block randomized, placebo-controlled, seamless two-part, adaptive phase 2/3 study. The adaptive phase 2/3 trial consists of two parts. In phase 2, the optimal dose of BLS-ILB-E710c is determined based on the histopathological regression. In phase 3, the efficacy of BLS-ILB-E710c is assessed. Results In a previous clinical trial, there was no difference in the rate of histopathological regression in the group taking the BLS-ILB-E710c 1000 mg per day compared to the placebo group at Week 16. However, in the sub-group analysis of CIN 3 patients, the rate of histopathological regression in the experimental group increased statistically significantly at Week 32 compared to Week 16. Additionally, a significant change in CD8+ T cells in the cervix was observed in the experimental group at Week 32. Based on these results, we’ll add a group taking BLS-ILB-E710c 1500 mg per day and confirm the histopathological regression at week 32 instead of week 16. Conclusions Conclusion/Implications – In order to improve the results of the existing clinical trial, stratified randomization will be performed using age and baseline CIN as factors. Additionally, to discover biomarkers of CIN, an extension study will be conducted only on patients with histopathological regression.