Trial · NCT03926130
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
NCT03926130, Phase 3, Completed, Eli Lilly and Company; results first posted 2024-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease. Trials, record NCT03926130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03926130
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
- NCT number
- NCT03926130
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,158 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Crohn's Disease
- Interventions
- Mirikizumab, Mirikizumab, Ustekinumab, Ustekinumab, Placebo, Placebo
- First posted
- 2019-04-24
- Last updated
- 2024-12-27
- Other registries' IDs
- eudract:2018-004614-18
- Results first posted
- 2024-12-27
- Limitations and caveats
After enrolling 6 participants, sponsor elected to stop enrollment of adolescents in study AMAM and enroll pediatric participants in a separate, pediatric study. The 6 enrolled participants were allowed to continue treatment and finish the study.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; \>2 cm=3); extent of ulcerated surface (none=0; \<10%=1; 10% to 30%=2; \>30%=3); extent of affected surface (none=0; \<50%=1; 50% to 75%=2; \>75%=3); presence \& type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. |
| Primary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score \<150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]).. Total score range of 0 to 600 points. |
| Secondary | Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Week 12 | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. |
| Secondary | Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Week 52 | Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. |
| Secondary | Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) | Week 12 | Clinical remission defined as CDAI total score \<150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]). Total score range of 0 to 600 points. |
| Secondary | Percentage of Adult Participants Achieving Clinical Remission at Week 52 | Week 52 | Clinical remission defined as CDAI total score \<150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]). Total score range of 0 to 600 points. |
| Secondary | Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) | Week 12 | Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore \>1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) \>1. |
| Secondary | Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) | Baseline, Week 12 | The Urgency NRS is a single patient-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). |
| Secondary | Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) | Baseline, Week 52 | The Urgency NRS is a single patient-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). |
| Secondary | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
| PRIMARY | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Week 12 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Week 52 | All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol. | percentage of participants | MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) | Week 12 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Clinical Remission at Week 52 | Week 52 | All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol. | percentage of participants | MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) | Week 12 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
| SECONDARY | Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) | Baseline, Week 12 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) | Baseline, Week 52 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) | Week 12 to Week 52 | All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug. | percentage of participants | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Placebo | 9.0 | 95% Confidence Interval 5.1 to 13.0 | percentage of participants | |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) | Mirikizumab | 38.0 | 95% Confidence Interval 34.0 to 42.0 | percentage of participants | |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Placebo | 19.6 | 95% Confidence Interval 14.1 to 25.1 | percentage of participants | |
| Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) | Mirikizumab | 45.4 | 95% Confidence Interval 41.4 to 49.5 | percentage of participants | |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Placebo | 12.6 | 95% Confidence Interval 8.0 to 17.2 | percentage of participants | |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) | Mirikizumab | 32.5 | 95% Confidence Interval 28.7 to 36.3 | percentage of participants | |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Placebo | 9 | 95% Confidence Interval 5.1 to 13.0 | percentage of participants | |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Mirikizumab | 48.4 | 95% Confidence Interval 44.3 to 52.4 | percentage of participants | |
| Percentage of Adult Participants Achieving Endoscopic Response at Week 52 | Ustekinumab | 46.3 | 95% Confidence Interval 40.6 to 52.1 | percentage of participants | |
| Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) | Placebo | 25.1 | 95% Confidence Interval 19.1 to 31.2 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 212 | |
| Overall Study | STARTED | Mirikizumab | 631 | |
| Overall Study | STARTED | Ustekinumab | 309 | |
| Overall Study | STARTED | Mirikizumab (Adolescents) | 6 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 211 | |
| Overall Study | Received at Least One Dose of Study Drug | Mirikizumab | 630 | |
| Overall Study | Received at Least One Dose of Study Drug | Ustekinumab | 309 | |
| Overall Study | Received at Least One Dose of Study Drug | Mirikizumab (Adolescents) | 6 | |
| Overall Study | Placebo Non-Responder at Week 12 | Placebo | 85 | |
| Overall Study | Placebo Non-Responder at Week 12 | Mirikizumab | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events560
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 | 10 | 211 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Non-Responders | 9 | 85 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Mirikizumab | 43 | 630 | 49 |
| other | Anaemia | Blood and lymphatic system disorders | Ustekinumab | 15 | 309 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Mirikizumab (Adolescents) | 0 | 6 | 0 |
| other | Crohn's disease | Gastrointestinal disorders | Placebo | 21 | 211 | 22 |
| other | Crohn's disease | Gastrointestinal disorders | Placebo Non-Responders | 4 | 85 | 4 |
| other | Crohn's disease | Gastrointestinal disorders | Mirikizumab | 17 | 630 | 19 |
| other | Crohn's disease | Gastrointestinal disorders | Ustekinumab | 14 | 309 | 16 |
| other | Crohn's disease | Gastrointestinal disorders | Mirikizumab (Adolescents) | 1 | 6 | 1 |
1 to 10 of 560Source ClinicalTrials.gov
See all 560 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 211 |
| Total, all-cause mortality | Placebo Non-Responders | 1 | 85 |
| Total, all-cause mortality | Mirikizumab | 0 | 630 |
| Total, all-cause mortality | Ustekinumab | 1 | 309 |
| Total, all-cause mortality | Mirikizumab (Adolescents) | 0 | 6 |
| Total, other adverse events | Placebo | 66 | 211 |
| Total, other adverse events | Placebo Non-Responders | 27 | 85 |
| Total, other adverse events | Mirikizumab | 300 | 630 |
| Total, other adverse events | Ustekinumab | 131 | 309 |
| Total, other adverse events | Mirikizumab (Adolescents) | 5 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers10
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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GET https://conductscience.org/api/trials/v1/NCT03926130/results?page=2