Clinical trial · Interventional
A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
NCT03274206CI-TRIAL-00043261unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimental drug, while 1/3 of participants will receive placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLS-ILB-E710c | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BLS-ILB-E710c
- description
- * Drug: BLS-ILB-E710c 1,000mg * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
- interventionNames
- Biological: BLS-ILB-E710c
- type
- PLACEBO_COMPARATOR
- label
- BLS-ILB-E710c-placebo
- description
- * Drug: BLS-ILB-E710c-placebo * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Regression rate
- timeFrame
- Baseline through Week 16
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Fertile female aged between 20 and 49 * Subjects who are infected with HPV 16 type only or with HPV 16 type and any other types listed below 1\) low risk type of HPV, 2) HPV 16-related type * Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by colposcopic biopsy within 6 weeks before enrollment * All lesions must be observable by colposcopy and CIN2 or higher lesion must be less than 1/2 in the transformation zone area * Willing to use adequate contraception methods during the study period * Eligible based on screening test results * Normal electrocardiogram * Voluntarily signed informed consent form Exclusion Criteria: * Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious invation * Presence of adenocarcinoma or glandular lesion in the cervix * Subjects who are infected with HPV type 18-related type * Subjects with autoimmune disease * Current or prior treatment past 2 months with immunosuppressant therapies * Hypersensitive to the investigational drug * Subjects who currently have acute diseases that require medical attention * Participation in other studies involving investigational drug(s) or investigational device(s) within 3 months * Currently having chronic pancreatitis or diagnosed with acute pancreatitis * Currently having underlying diseases including inflammatory intestinal diseases and tumors, ulcer, bleeding or puncture in the gastrointestinal tract * Pregnant or breastfeeding * Subjects with active or inactive hepatitis, or infectious disease * History of HIV infection * History of therapeutic HPV vaccination * Subjects who require continuous use of antibiotics * Administration of blood product within 3 months before signing informed consent form * History of vaccination within 2 months before signing informed consent form (4 months in case of live vaccine)
References
Publications (0)
Data not yet available
No reference posted for this study.