Trial · NCT03524092
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03524092, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Trials, record NCT03524092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03524092
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
- NCT number
- NCT03524092
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,328 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Ulcerative Colitis
- Interventions
- Mirikizumab SC, Mirikizumab IV, Placebo SC
- First posted
- 2018-05-14
- Last updated
- 2026-05-13
- Other registries' IDs
- eudract:2017-003238-96
- Results first posted
- 2022-11-25
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 in Clinical Remission at Week 40 (Mirikizumab Induction Responders) | Week 40 | Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). 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) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received. |
| Secondary | Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders) | Week 40 | Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). |
| Secondary | Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders) | Week 40 | 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 in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders) | Week 40 | Symptomatic remission at week 40 is defined as a Mayo score 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). |
| Secondary | Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders) | Week 40 | Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. |
| Secondary | Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders) | Week 40 | Clinical response at week 40 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). |
| Secondary | Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders) | Induction Baseline, Week 40 | 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. 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), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other). |
| Secondary | Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders) | Induction Baseline, Week 40 | 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 ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12. |
| Secondary | Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders) | Induction Baseline, Week 40 | 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), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other). |
| Secondary | Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders) | Week 40 | Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with \>=24 hours stay were recorded. |
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 in Clinical Remission at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Endoscopic Remission at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Histologic Remission at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Symptomatic Remission at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Endoscopic Response at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Clinical Response at Week 40 | Week 40 | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | Induction Baseline, Week 40 | Modified Intention-to-treat population (mITT): 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 40 in Fecal Calprotectin | Induction Baseline, Week 40 | Modified Intention-to-treat population (mITT): 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. | milligram per kilogram (mg/kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) | Induction Baseline, Week 40 | Modified Intention-to-treat population (mITT): 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Hospitalized for Ulcerative Colitis (UC) | Week 40 | Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received. | percentage of participants | NUMBER |
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 in Clinical Remission at Week 40 | Maintenance Period: Miri IR - PBO SC | 25.1 | 95% Confidence Interval 18.8 to 31.5 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 40 | Maintenance Period: Miri IR - 200 mg Miri SC | 49.9 | 95% Confidence Interval 44.7 to 55.0 | percentage of participants | |
| Percentage of Participants in Endoscopic Remission at Week 40 | Maintenance Period: Miri IR - PBO SC | 29.1 | 95% Confidence Interval 22.4 to 35.7 | percentage of participants | |
| Percentage of Participants in Endoscopic Remission at Week 40 | Maintenance Period: Miri IR - 200 mg Miri SC | 58.6 | 95% Confidence Interval 53.6 to 63.7 | percentage of participants | |
| Percentage of Participants With Histologic Remission at Week 40 | Maintenance Period: Miri IR - PBO SC | 24.6 | 95% Confidence Interval 18.3 to 30.9 | percentage of participants | |
| Percentage of Participants With Histologic Remission at Week 40 | Maintenance Period: Miri IR - 200 mg Miri SC | 48.5 | 95% Confidence Interval 43.4 to 53.6 | percentage of participants | |
| Percentage of Participants in Symptomatic Remission at Week 40 | Maintenance Period: Miri IR - PBO SC | 39.7 | 95% Confidence Interval 32.5 to 46.8 | percentage of participants | |
| Percentage of Participants in Symptomatic Remission at Week 40 | Maintenance Period: Miri IR - 200 mg Miri SC | 71.0 | 95% Confidence Interval 66.3 to 75.6 | percentage of participants | |
| Percentage of Participants in Endoscopic Response at Week 40 | Maintenance Period: Miri IR - PBO SC | 40.8 | 95% Confidence Interval 33.6 to 48.0 | percentage of participants | |
| Percentage of Participants in Endoscopic Response at Week 40 | Maintenance Period: Miri IR - 200 mg Miri SC | 72.6 | 95% Confidence Interval 68.0 to 77.2 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Maintenance Period (Wk 0-40) | STARTED | Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) | 192 | |
| Blinded Maintenance Period (Wk 0-40) | STARTED | Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC | 389 | |
| Blinded Maintenance Period (Wk 0-40) | STARTED | Maintenance Period: PBO IR - PBO SC | 135 | |
| Blinded Maintenance Period (Wk 0-40) | STARTED | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 0 | |
| Blinded Maintenance Period (Wk 0-40) | STARTED | Extended Induction: Induction Nonresponders - 300mg Miri IV | 0 | |
| Blinded Maintenance Period (Wk 0-40) | STARTED | Open Label Maintenance: Delayed Responders - 200 mg Miri SC | 0 | |
| Blinded Maintenance Period (Wk 0-40) | Received at Least One Dose of Study Drug | Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) | 192 | |
| Blinded Maintenance Period (Wk 0-40) | Received at Least One Dose of Study Drug | Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC | 389 | |
| Blinded Maintenance Period (Wk 0-40) | Received at Least One Dose of Study Drug | Maintenance Period: PBO IR - PBO SC | 135 | |
| Blinded Maintenance Period (Wk 0-40) | Received at Least One Dose of Study Drug | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events402
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 | Maintenance Period: Miri IR - PBO SC | 9 | 192 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Period: Miri IR - 200 mg Miri SC | 8 | 389 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Period: PBO IR - PBO SC | 8 | 135 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 5 | 90 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Extended Induction: Induction Nonresponders - 300mg Miri IV | 7 | 461 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Open Label Maintenance: Delayed Responders - 200 mg Miri SC | 9 | 271 | 9 |
| other | Colitis ulcerative | Gastrointestinal disorders | Maintenance Period: Miri IR - PBO SC | 35 | 192 | 35 |
| other | Colitis ulcerative | Gastrointestinal disorders | Maintenance Period: Miri IR - 200 mg Miri SC | 26 | 389 | 30 |
| other | Colitis ulcerative | Gastrointestinal disorders | Maintenance Period: PBO IR - PBO SC | 17 | 135 | 18 |
| other | Colitis ulcerative | Gastrointestinal disorders | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 0 | 90 | 0 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maintenance Period: Miri IR - PBO SC | 1 | 192 |
| Total, all-cause mortality | Maintenance Period: Miri IR - 200 mg Miri SC | 0 | 389 |
| Total, all-cause mortality | Maintenance Period: PBO IR - PBO SC | 0 | 135 |
| Total, all-cause mortality | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 0 | 90 |
| Total, all-cause mortality | Extended Induction: Induction Nonresponders - 300mg Miri IV | 0 | 461 |
| Total, all-cause mortality | Open Label Maintenance: Delayed Responders - 200 mg Miri SC | 0 | 271 |
| Total, other adverse events | Maintenance Period: Miri IR - PBO SC | 57 | 192 |
| Total, other adverse events | Maintenance Period: Miri IR - 200 mg Miri SC | 90 | 389 |
| Total, other adverse events | Maintenance Period: PBO IR - PBO SC | 37 | 135 |
| Total, other adverse events | Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV | 13 | 90 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers13
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03524092
GET https://conductscience.org/api/trials/v1/NCT03524092/results?page=2