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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBI | Other Identifier | Eli Lilly and Company | |
| 2019-001653-99 | EudraCT Number |
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The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
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The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab | Experimental | Mirikizumab administered intravenously (IV) and subcutaneously (SC). |
|
| Vedolizumab | Active Comparator | Vedolizumab administered IV. |
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| Placebo | Placebo Comparator | Placebo administered SC and IV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab IV | Drug | Administered IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Histologic Remission | Histologic remission based on histology. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Symptomatic Remission | Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores. | Week 52 |
| Percentage of Participants in Clinical Remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
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| Label | URL |
|---|---|
| A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab SC | Drug | Administered SC |
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| Vedolizumab IV | Drug | Administered IV |
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| Placebo IV | Drug | Administered IV |
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| Placebo SC | Drug | Administered SC |
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Clinical remission based on MMS.
| Week 52 |
| Percentage of Participants in Endoscopic Remission | Endoscopic remission based on MMS ES. | Week 52 |
| Percentage of Participants with Clinical Response | Clinical response based on MMS. | Week 12 |
| Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline) | CS free remission without surgery based on clinical remission, symptomatic remission and no CS use. | Week 52 |
| Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline | Percentage of participants with resolution of EIMs among those that had them at baseline. | Week 52 |
| Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score | Change from baseline on the IBDQ score. | Baseline, Week 52 |
| Percentage of Participants Undergoing Surgery for UC (Including Colectomy) | Percentage of participants undergoing surgery for UC (including colectomy). | Week 52 |
| Percentage of Participants Hospitalized for UC | Percentage of participants hospitalized for UC. | Week 52 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |