A phase 3 Clinical Study with study drug Mirikizumab, on patients who have Biologically failed with Active inflammatory bowel disease (IBD) in which the lining of the large intestine (colon or bowel) and the rectum becomes inflamed

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis LUCENT 1 - LUCENT 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/015908

Enrollment

1160

Registered

2018-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: blinded intravenous administration of 300 mg mirikizumab: Patients will be randomized with 3:1 ratio to receive blinded Intravenous Administration Duration of treatment with the invest

Eligibility

Inclusion criteria

Inclusion criteria: - Diagnosis of UC for at least 3 months prior to baseline. - Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). - Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. - If female, must meet the contraception requirements.

Exclusion criteria

Exclusion criteria: -Participants with a current diagnosis of chrons disease or inflammatory bowel disease unclassified (indeterminate colitis) - participants with previous colectomy - participants with current evidence of toxic megacolon - Prior exposure to anti IL 12p40 antibodies e.g ustekinumab or anti IL 23p19 antibodies e.g risankizumab, brazikumab, guselkumab, tildrakizumab

Design outcomes

Primary

Measure	Time frame
percentage of participants in Clinical Remission. Clinical remission based on the modified Mayo Score (MMS)Timepoint: timeframe week 12	—

Secondary

Measure	Time frame
Change from Baseline to Week 12 in Fecal CalprotectinTimepoint: [ Time Frame: Baseline, Week 12 ] Change from baseline to Week 12 in fecal calprotectin ;Changes from baseline to week 12 in health related Quality of life: Inflammatory Bowel Disease Questionnaire (IBDQ)Timepoint: [ Time Frame: Baseline, Week 12 ] Health Related Quality of Life based on IBDQ score. ;Percentage of Participants in Clinical ResponseTimepoint: [ Time Frame: Week 12 ] Clinical response based on the MMS. ;Percentage of Participants in Endoscopic RemissionTimepoint: [ Time Frame: Week 12 ] Endoscopic remission based on the MMS Endoscopic Subscore (ES) ;Percentage of Participants in Endoscopic ResponseTimepoint: [ Time Frame: Week 12 ] Endoscopic response based on the MMS ES. ;Percentage of Participants in Symptomatic RemissionTimepoint: [ Time Frame: Week 12 ] Symptomatic remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) subscores ;Percentage of Participants in Symptomatic ResponseTimepoint: [ Time Frame: Week 12 ] Symptomatic response based on MMS SF and RB subscores.;Percentage of Participants with Mucosal HealingTimepoint: [ Time Frame: Week 12 ] Mucosal healing based on a histologic disease activity index.;Pharmacokinetics (PK): Clearance of MirikizumabTimepoint: Time Frame: Weeks 0, 4, 8 and 12: Pre-Dose; Week 0 and 4: Up to 2 hour Post-Dose ] Clearance of Mirikizumab	—

Measure

Time frame

Change from Baseline to Week 12 in Fecal CalprotectinTimepoint: [ Time Frame: Baseline, Week 12 ] Change from baseline to Week 12 in fecal calprotectin ;Changes from baseline to week 12 in health related Quality of life: Inflammatory Bowel Disease Questionnaire (IBDQ)Timepoint: [ Time Frame: Baseline, Week 12 ] Health Related Quality of Life based on IBDQ score. ;Percentage of Participants in Clinical ResponseTimepoint: [ Time Frame: Week 12 ] Clinical response based on the MMS. ;Percentage of Participants in Endoscopic RemissionTimepoint: [ Time Frame: Week 12 ] Endoscopic remission based on the MMS Endoscopic Subscore (ES) ;Percentage of Participants in Endoscopic ResponseTimepoint: [ Time Frame: Week 12 ] Endoscopic response based on the MMS ES. ;Percentage of Participants in Symptomatic RemissionTimepoint: [ Time Frame: Week 12 ] Symptomatic remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) subscores ;Percentage of Participants in Symptomatic ResponseTimepoint: [ Time Frame: Week 12 ] Symptomatic response based on MMS SF and RB subscores.;Percentage of Participants with Mucosal HealingTimepoint: [ Time Frame: Week 12 ] Mucosal healing based on a histologic disease activity index.;Pharmacokinetics (PK): Clearance of MirikizumabTimepoint: Time Frame: Weeks 0, 4, 8 and 12: Pre-Dose; Week 0 and 4: Up to 2 hour Post-Dose ] Clearance of Mirikizumab

—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactSuneela Thatte

IQVIA RDS (India) Private Limited

suneela.thatte@quintiles.com912266774242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026