Trial record 1 of 1 for:
I6T-MC-AMBG
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03524092 |
|
Recruitment Status :
Recruiting
First Posted : May 14, 2018
Last Update Posted : February 19, 2019
|
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: Mirikizumab Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1044 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | October 19, 2018 |
| Estimated Primary Completion Date : | June 15, 2021 |
| Estimated Study Completion Date : | March 22, 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Mirikizumab Dose #1
Mirikizumab Dose #1 administered subcutaneously (SC)
|
Drug: Mirikizumab
Administered SC
Other Name: LY3074828 |
|
Experimental: Mirikizumab Dose #2
Mirikizumab Dose #2 administered intravenously (IV)
|
Drug: Mirikizumab
Administered IV
Other Name: LY3074828 |
|
Placebo Comparator: Placebo
Placebo administered SC
|
Drug: Placebo
Administered SC
Other Name: LY3074828 |
Primary Outcome Measures :
- Percentage of Participants in Clinical Remission [ Time Frame: Week 40 ]Clinical remission based on modified Mayo Score (MMS).
Secondary Outcome Measures :
- Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ]Endoscopic remission based on MMS Endoscopic Subscore (ES).
- Percentage of Participants with Mucosal Healing [ Time Frame: Week 40 ]Mucosal healing based on histology.
- Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ]Endoscopic response based on the MMS ES.
- Percentage of Participants in Clinical Response [ Time Frame: Week 40 ]Clinical response based on the MMS.
- Change from Baseline to Week 40 in Health Related Quality of Life [ Time Frame: Baseline, Week 40 ]Health Related Quality of Life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score.
- Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ]Change from baseline in fecal calprotectin.
- Change from Baseline to Week 40 in Ulcerative Colitis (UC) Symptoms: Numeric Rating Score (NRS) [ Time Frame: Baseline, Week 40 ]UC symptoms based on NRS scores.
- Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ]Percentage of participants hospitalized for UC.
- Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ]Clearance of mirikizumab
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- If female, must meet the contraception requirements.
Exclusion Criteria:
- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
- Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
- Participants 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 (NCT03518086).
- Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
- Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524092
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |
Show 532 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT03524092 History of Changes |
| Other Study ID Numbers: |
16823 I6T-MC-AMBG ( Other Identifier: Eli Lilly and Company ) 2017-003238-96 ( EudraCT Number ) |
| First Posted: | May 14, 2018 Key Record Dates |
| Last Update Posted: | February 19, 2019 |
| Last Verified: | February 1, 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Eli Lilly and Company:
|
Interleukin-23 (IL-23) IL-23p19 Inflammatory Bowel Disease |
Additional relevant MeSH terms:
|
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |