Clinical Trials List
2018-09-01 - 2022-05-25
Phase III
Recruiting10
Terminated1
ICD-10K51.90
Ulcerative colitis, unspecified, without complications
ICD-10K51.00
Ulcerative (chronic) pancolitis without complications
ICD-9556.9
Ulcerative colitis, unspecified
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis LUCENT 2
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳耿良 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳介章 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
CRO
Co-Principal Investigator
- Tiong Cheng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Deng-Chyang Wu Digestive System Department
- I-CHEN WU Digestive System Department
- Chien-Yu Lu Digestive System Department
- HSIANG YAO SHIH Digestive System Department
- Wen-Hung Hsu Digestive System Department
- Fang-Jung Yu Yu Digestive System Department
- Huang-Ming Hu Digestive System Department
- Chao-Hung Kuo Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• The proportion of patients in clinical remission at Week 40, defined as:
o Stool frequency (SF) subscore = 0, or SF = 1 with a ≥1-point decrease from induction
baseline, and
o Rectal bleeding (RB) subscore = 0, and
o Endoscopic subscore (ES) = 0 or 1 (excluding friability).
Inclution Criteria
Patients are eligible to be included in the study only if they meet all of the following criteria at maintenance study baseline, unless specifically defined:
Informed Consent
[1.] Have given written informed consent approved by the ethical review board (ERB) governing the site prior to any study-specific procedures being completed.
Patient Characteristics
[2.] Have completed Study AMAN through the Week 12 visit (Visit 5) and have a Visit 5 MMS and have received at least 1 study drug administration without early termination of study drug.
[3.] Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
[4.] Contraception
[4a.] Male patients:
No male contraception required except in compliance with specific local government study requirements
[4b.] Female patients:
Women of childbearing potential:
A. Must test negative for pregnancy prior to initiation of treatment as indicated by a negative urine pregnancy test at Visit 1/Week 0 of this study.
AND
B. Must agree to either remain abstinent, if complete abstinence is their preferred and usual lifestyle, or remain in same-sex relationships, if part of their preferred and usual lifestyle, without sexual relationships with males. Periodic abstinence (for example, calendar, ovulation, symptothermal, or post ovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
OR
Must use 2 effective methods of contraception for the entirety of the study. Abstinence or contraception must continue following completion of study drug administration for 20 weeks
i. 2 effective methods of contraception (such as male or female condoms with spermicide, diaphragms with spermicide or cervical sponges) will be used. The patient may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.
ii. Of note, 1 of the 2 methods of contraception may be a highly effective (less than 1% failure rate) method of contraception (such as combination oral contraceptives, implanted contraceptives or intrauterine devices).
Women not of childbearing potential may participate and include those who are:
A. Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly, such as mullerian agenesis; or
B. Postmenopausal – defined as either
i. A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either
• Cessation of menses for at least 1 year or
• At least 6 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) >40 mIU/mL; or
ii. A woman 55 years or older not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or
iii. A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy.
[5.] Have documentation of the following:
[5a.] A surveillance colonoscopy (performed according to local standard) within 12 months before baseline for:
• Patients with pancolitis of >8 years’ duration, or
• Patients with left-sided colitis of >12 years’ duration, or
• Patients with primary sclerosing cholangitis.
OR
[5b.] In patients for whom Inclusion Criterion [5a] does not apply, up to date screening for colorectal cancer (performed according to local standard).
A full colonoscopy can be performed as part of the Week 12 procedures in Study AMAN to satisfy this inclusion criterion for Study AMBG.
Exclusion Criteria
Patients will be excluded from study enrollment if they meet any of the following criteria at maintenance study baseline, unless specifically defined:
Gastrointestinal Exclusion Criteria
[6.] Have been diagnosed during the previous induction study AMAN with Crohn’s disease or Inflammatory Bowel Disease-Unclassified (IBD-U, formerly known as indeterminate colitis).
[7.] Have had bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during Study AMBG.
[8.] Have evidence of colonic dysplasia (including dysplasia in flat mucosa or dysplasia-associated lesion or mass [DALM]) at maintenance baseline (Study AMAN Visit 5 [Week 12] endoscopy) or have been diagnosed with cancer of the gastrointestinal tract during Study AMAN.
[9.] Have current adenomatous polyps that have not been removed. Once removed, the patient may be eligible for study after confirming no dysplasia or malignancy on local histology report.
Infectious Disease Exclusion
[10.] Have been diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN.
[11.] Have detectable hepatitis B virus (HBV) DNA detected at any time in Study AMAN
[12.] Have been diagnosed with latent TB during the induction study AMAN and are not willing to comply with completing TB treatment as appropriate.
[13.] Intend to receive a Bacillus Calmette-Guerin (BCG) vaccination or live attenuated vaccine(s) during the study.
General Exclusion Criteria
[14.] Initiation of a new prohibited medication during the induction study AMAN.
[15.] Presence of a hepatic or hematologic laboratory abnormality prior to Visit 1/Week 0 that would require permanent discontinuation from study drug.
[16.] Presence of significant uncontrolled neuropsychiatric disorder or judged at risk of suicide in the opinion of the investigator;
OR
Marked “yes” to Columbia-Suicide Severity Rating Scale (C-SSRS) question 4 or 5 on ideation prior to dosing;
OR
Marked “yes” to C-SSRS suicide behaviors questions prior to dosing at Week 0;
AND
The ideation or behavior occurred within the past month.
[17.] Have an unstable or uncontrolled illness, including, but not limited to, cerebro-cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic or neurological disorders or malignancy that would potentially affect patient safety within the study or confound efficacy assessment.
[18.] Have a known systemic hypersensitivity to any component of this investigational product, or has experienced an acute systemic hypersensitivity event with previous study drug administration, that precludes mirikizumab therapy.
[19.] Are pregnant, lactating, or planning pregnancy (women only) while enrolled in the study, or within 12 weeks after receiving the last dose of study drug (or within 20 weeks if patient received less than 2 SC doses and decides to terminate study participation early for any reason during Study AMBG).
[20.] Became a Lilly employee, employee of third party organizations involved with the study, or investigator site personnel directly affiliated with this study and/or their immediate families, during the previous induction study AMAN.
[21.] Have enrolled in another clinical trial involving an investigational product or nonapproved use of a drug or device during Study AMAN, OR are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
[22.] Have previously completed or withdrawn from Study AMBG or any other study investigating mirikizumab, except for completion of 12 weeks of induction study AMAN.
[23.] Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient daily for the duration of Study AMBG, or are unable to complete other study procedures.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
1044 participants
