Cervical Intraepithelial Neoplasia Grade 2/3Phase 2NCT03274206
A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
A Phase 2 study testing BLS-ILB-E710c in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by BioLeaders Corporation at 14 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3
- What is being tested?
- BLS-ILB-E710c
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 30 Aug 2017to Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- Eligible based on screening test results
- Normal electrocardiogram
- Voluntarily signed informed consent form
Who cannot join
- 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
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- 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)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites, 14 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Geyonggi-do, 15355
Nak-Woo Lee, MD, PhD, +82-2-2626-3142, jklee38@kumc.or.kr
- Recruiting
The Dongsan Medical Center of Keimyung Hospital
Daegu, 700-712
Chi-Heum Cho, MD, PhD, +82-53-250-7518, c0035@dsmc.or.kr
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Jin Woo Shin, MD, PhD, +82-32-460-3823, jwshin@gilhospital.com
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496
Seung Hun Song, MD, PhD
Suim Park, suim1227@chamc.co.kr
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae-Weon Kim, MD, PhD, +82-2-2072-3511
Yeon-Jae Han
- Recruiting
Yonsei Unversity Health System
Seoul, 03722
Young Tae Kim, MD, PhD, +82-2-2228-2230, ytkchoi@yuhs.ac
So Yeon Joo, +82-2-2228-5735, 70000ddal@yuhs.ac
- Recruiting
University of Ulsan College of Medicine, Asan Medical Center
Seoul, 05505
Yong-Man Kim, MD, Ph.D, +82-2-3010-3640
Geum-hee Nah, +82-2-3010-3627
- Recruiting
Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Soo Young Hur, MD, Ph.D, hursy@catholic.ac.kr
Hee Sook Bae, prigia83@naver.com
- Recruiting
Hallym University Medical Center
Seoul, 07441
Sung Taek Park, MD, PhD, +82-2-829-5151, parkst96@naver.com
- Recruiting
Kwandong University College of Medicine Cheil Hospital
Seoul, 100-380
Tae Jin Kim, MD, PhD, +82-2-2000-7177, kimonc@hotmail.com
- Recruiting
CHA Gangnam Hospital
Seoul, 135-913
Seok Ju Seong, MD, PhD
- Recruiting
Korea University Guro Hospital
Seoul, 152-703
Jae-Kwan Lee, MD, PhD, +82-2626-3142, jklee38@korea.ac.kr
Jae-Kwan Lee, MD, PhD
- Recruiting
Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Sung Jong Lee, MD, PhD, +82-31-249-8301, orlando@catholic.ac.kr
- Recruiting
Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
Jin Hui Kim, MD, PhD, kjh@catholic.ac.kr
About this study
Official title: A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
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.
Read the detailed description
Primary Outcome Measure:
Complete histopathological regression from baseline [Time Frame: Baseline through Week 16]
Secondary Outcome Measures:
- Change from baseline of CIN classification [Time Frame: Baseline through Week 16]
- Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline of cytopathological classification based on bethesda system [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo in HPV 16 clearance rate
- Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16 through Week 32]
- Being tested
- BLS-ILB-E710c, Placebo
- Keywords
- Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLS-ILB-E710cBiological
BLS-ILB-E710c 250mg/capsule
PlaceboDrug
BLS-ILB-E710c-placebo
| Study group | Role | What they receive |
|---|---|---|
| BLS-ILB-E710c | Experimental | * Drug: BLS-ILB-E710c 1,000mg
* Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) Receives: Biological: BLS-ILB-E710c |
| BLS-ILB-E710c-placebo | Placebo comparator | * Drug: BLS-ILB-E710c-placebo
* Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression rate
The rate of complete histopathological regression from baseline as compared to placebo
Measured: Baseline through Week 16
Secondary outcomes (7)
CIN classification
Change from baseline of CIN classification
Measured: Baseline through Week 16
Change of Reid's Colposcopic Index (RCI)
Change from baseline of RCI
Measured: Baseline through Week 16 and Week 32
Cytopathological classification
Change from baseline of cytopathological classification based on bethesda system
Measured: Baseline through Week 16 and Week 32
Expression rate of P16/Ki-67
Change from baseline as compared to placebo of the expression rate of P16/Ki-67
Measured: Baseline through Week 16
The number of CD8 positive cells in the cervix
Change from baseline as compared to placebo in the number of CD8 positive cells in the cervix
Measured: Baseline through Week 16
HPV 16 clearance rate
Change from baseline as compared to placebo in HPV 16 clearance rate
Measured: Baseline through Week 16
Change of RCI
Change of RCI based on the histopathological regression at Week 16
Measured: Week 16 and Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start30 Aug 2017
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioLeaders Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Kwan Lee, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274206
- Sponsor's protocol ID
- BLS-ILB-E710c-202
- Other IDs
- 12591
- Status last verified
- Feb 2020
- First submitted
- 5 Sep 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
- ClinicalTrials.gov ID
- NCT03274206
- Acronym / sponsor ID
- BLS-ILB-E710c-202
- Keywords
- Cervical Intraepithelian Neoplasia Grade 2/3, CIN 2/3, HPV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- BioLeaders CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Outcome Measure:
Complete histopathological regression from baseline [Time Frame: Baseline through Week 16]
Secondary Outcome Measures:
- Change from baseline of CIN classification [Time Frame: Baseline through Week 16]
- Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline of cytopathological classification based on bethesda system [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo in HPV 16 clearance rate
- Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16 through Week 32]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLS-ILB-E710c | Experimental | Biological: BLS-ILB-E710c* Drug: BLS-ILB-E710c 1,000mg * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) |
| BLS-ILB-E710c-placebo | Placebo comparator | Drug: Placebo* Drug: BLS-ILB-E710c-placebo * Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8) |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLS-ILB-E710cBLS-ILB-E710c 250mg/capsule | Biological | BLS-ILB-E710c |
| PlaceboBLS-ILB-E710c-placebo | Drug | BLS-ILB-E710c-placebo |
Primary outcome
Regression rate
Time frame: Baseline through Week 16
The rate of complete histopathological regression from baseline as compared to placebo
7 secondary outcomes
CIN classification
Time frame: Baseline through Week 16
Change of Reid's Colposcopic Index (RCI)
Time frame: Baseline through Week 16 and Week 32
Cytopathological classification
Time frame: Baseline through Week 16 and Week 32
Expression rate of P16/Ki-67
Time frame: Baseline through Week 16
The number of CD8 positive cells in the cervix
Time frame: Baseline through Week 16
HPV 16 clearance rate
Time frame: Baseline through Week 16
Change of RCI
Time frame: Week 16 and Week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Kwan Lee, MD, PhD principal investigator
Korea University Guro Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLS-ILB-E710c in people with Cervical Intraepithelial Neoplasia Grade 2/3, run by BioLeaders Corporation at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hyung Lee (+82-31-280-9622, jhlee@bioleaders.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression rate (time frame: Baseline through Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.