Trial · NCT03518086
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
NCT03518086, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1). Trials, record NCT03518086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03518086
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
- NCT number
- NCT03518086
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,281 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Ulcerative Colitis
- Interventions
- Mirikizumab, Placebo
- First posted
- 2018-05-08
- Last updated
- 2025-05-31
- Other registries' IDs
- eudract:2017-003229-14
- Results first posted
- 2022-02-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Remission at Week 12 | Week 12 | Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The confidence interval of 99.88% was chosen to match the significance level. |
| Secondary | Percentage of Participants With Clinical Response at Week 12 | Week 12 | Clinical response at week 12 is defined as a decrease in the 9-point modified Mayo score (MMS) \[rectal bleeding, stool frequency and the endoscopic findings\] inclusive of \>= 2 points and \>=30% from baseline with either a decrease of rectal bleeding subscore of \>=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. |
| Secondary | Percentage of Participants With Endoscopic Remission at Week 12 | Week 12 | Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level. |
| Secondary | Percentage of Participants With Symptomatic Remission at Week 12 | Week 12 | Symptomatic remission at week 12 is defined as a Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline. Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). The confidence interval of 99.88% was chosen to match the significance level. |
| Secondary | Percentage of Participants With Symptomatic Response at Week 12 | Week 12 | Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding subscores. Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6. |
| Secondary | Percentage of Participants With Histologic Remission at Week 12 | Week 12 | Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration). |
| Secondary | Percentage of Participants With Endoscopic Response at Week 12 | Week 12 | Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease. |
| Secondary | Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) | Baseline, Week 12 | The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4-6\] or \[7-9\]), and region (North America/Europe/Other). |
| Secondary | Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | Baseline, Week 12 | The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4-6\] or \[7-9\]), and region (North America/Europe/Other). |
| Secondary | Change From Baseline to Week 12 in Fecal Calprotectin | Baseline, Week 12 | Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: \[4-6\] or \[7-9\]), and region (North America/Europe/Other). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Remission at Week 12 | Week 12 | Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Week 12 | Week 12 | mITT Population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Remission at Week 12 | Week 12 | mITT Population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptomatic Remission at Week 12 | Week 12 | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Symptomatic Response at Week 12 | Week 12 | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Histologic Remission at Week 12 | Week 12 | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Response at Week 12 | Week 12 | mITT population: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) | Baseline, Week 12 | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | Baseline, Week 12 | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Fecal Calprotectin | Baseline, Week 12 | mITT population: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.~As pre-specified in the analysis plan, outcome measures were not reported for ME2 arms,as no formal efficacy analysis was pre-specified for ME2 cohort but only for the main global study arms/groups. | milligram per kilogram (mg/kg) | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Remission at Week 12 | Placebo IV Q4W | 13.3 | 99.88% Confidence Interval 6.9 to 19.6 | percentage of participants | |
| Percentage of Participants With Clinical Remission at Week 12 | 300 mg Mirikizumab IV Q4W | 24.2 | 99.88% Confidence Interval 19.5 to 28.9 | percentage of participants | |
| Percentage of Participants With Clinical Response at Week 12 | Placebo IV Q4W | 42.2 | 99.88% Confidence Interval 32.9 to 51.5 | percentage of participants | |
| Percentage of Participants With Clinical Response at Week 12 | 300 mg Mirikizumab IV Q4W | 63.5 | 99.88% Confidence Interval 58.2 to 68.8 | percentage of participants | |
| Percentage of Participants With Endoscopic Remission at Week 12 | Placebo IV Q4W | 21.1 | 99.88% Confidence Interval 13.4 to 28.8 | percentage of participants | |
| Percentage of Participants With Endoscopic Remission at Week 12 | 300 mg Mirikizumab IV Q4W | 36.3 | 99.88% Confidence Interval 31.0 to 41.6 | percentage of participants | |
| Percentage of Participants With Symptomatic Remission at Week 12 | Placebo IV Q4W | 27.9 | 99.88% Confidence Interval 22.8 to 33.0 | percentage of participants | |
| Percentage of Participants With Symptomatic Remission at Week 12 | 300 mg Mirikizumab IV Q4W | 45.5 | 99.88% Confidence Interval 42.2 to 48.8 | percentage of participants | |
| Percentage of Participants With Symptomatic Response at Week 12 | Placebo IV Q4W | 52.4 | 95% Confidence Interval 46.7 to 58.1 | percentage of participants | |
| Percentage of Participants With Symptomatic Response at Week 12 | 300 mg Mirikizumab IV Q4W | 72.0 | 95% Confidence Interval 69.0 to 75.0 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo IV Q4W | 322 | |
| Overall Study | STARTED | 300 mg Mirikizumab IV Q4W | 959 | |
| Overall Study | STARTED | Placebo IV Q4W ME2 Cohort | 41 | |
| Overall Study | STARTED | 300 mg Mirikizumab IV Q4W ME2 Cohort | 125 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo IV Q4W | 321 | |
| Overall Study | Received at Least One Dose of Study Drug | 300 mg Mirikizumab IV Q4W | 958 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo IV Q4W ME2 Cohort | 41 | |
| Overall Study | Received at Least One Dose of Study Drug | 300 mg Mirikizumab IV Q4W ME2 Cohort | 125 | |
| Overall Study | COMPLETED | Placebo IV Q4W | 285 | |
| Overall Study | COMPLETED | 300 mg Mirikizumab IV Q4W | 920 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo IV Q4W | 18 | 321 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | 300 Mirikizumab IV Q4W | 31 | 958 | 32 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo IV Q4W ME2 Cohort | 4 | 41 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 300 mg Mirikizumab IV Q4W ME2 Cohort | 8 | 125 | 8 |
| other | Colitis ulcerative | Gastrointestinal disorders | Placebo IV Q4W | 0 | 321 | 0 |
| other | Colitis ulcerative | Gastrointestinal disorders | 300 Mirikizumab IV Q4W | 0 | 958 | 0 |
| other | Colitis ulcerative | Gastrointestinal disorders | Placebo IV Q4W ME2 Cohort | 3 | 41 | 3 |
| other | Colitis ulcerative | Gastrointestinal disorders | 300 mg Mirikizumab IV Q4W ME2 Cohort | 3 | 125 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo IV Q4W | 0 | 321 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | 300 Mirikizumab IV Q4W | 0 | 958 | 0 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo IV Q4W | 0 | 321 |
| Total, all-cause mortality | 300 Mirikizumab IV Q4W | 0 | 958 |
| Total, all-cause mortality | Placebo IV Q4W ME2 Cohort | 0 | 41 |
| Total, all-cause mortality | 300 mg Mirikizumab IV Q4W ME2 Cohort | 0 | 125 |
| Total, other adverse events | Placebo IV Q4W | 18 | 321 |
| Total, other adverse events | 300 Mirikizumab IV Q4W | 31 | 958 |
| Total, other adverse events | Placebo IV Q4W ME2 Cohort | 11 | 41 |
| Total, other adverse events | 300 mg Mirikizumab IV Q4W ME2 Cohort | 25 | 125 |
| Total, serious adverse events | Placebo IV Q4W | 17 | 321 |
| Total, serious adverse events | 300 Mirikizumab IV Q4W | 27 | 958 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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