NCT02589665

Brief Summary

The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2015

Typical duration for phase_2

Geographic Reach
16 countries

76 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 9, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 29, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

October 27, 2015

Results QC Date

May 7, 2020

Last Update Submit

June 10, 2020

Conditions

Ulcerative Colitis

Keywords

IL-23 antibody

Outcome Measures

Primary Outcomes (1)

  • Induction Period: Percentage of Participants With Clinical Remission at Week 12

    Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding 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) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.

    Week 12

Secondary Outcomes (12)

  • Induction Period: Percentage of Participants With Clinical Response at Week 12

    Week 12

  • Induction Period: Percentage of Participants With Endoscopic Remission at Week 12

    Week 12

  • Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52

    Week 52

  • Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    Baseline, Week 12

  • Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)

    Baseline, Week 12

  • +7 more secondary outcomes

Study Arms (10)

50 mg Mirikizumab IV Q4W (Induction)

EXPERIMENTAL

50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Drug: Mirikizumab

200 mg Mirikizumab IV Q4W (induction)

EXPERIMENTAL

200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Drug: Mirikizumab

600 mg Mirikizumab IV Q4W (Induction)

EXPERIMENTAL

600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.

Drug: Mirikizumab

Placebo IV Q4W (Induction)

PLACEBO COMPARATOR

Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.

Drug: Placebo

200 mg Mirikizumab SC Q4W (Maintenance)

EXPERIMENTAL

Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.

Drug: Mirikizumab

200 mg Mirikizumab SC Q12W (Maintenance)

EXPERIMENTAL

Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.

Drug: Mirikizumab

Placebo SC Q4W (Maintenance)

PLACEBO COMPARATOR

Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.

Drug: Placebo

600mg Mirikizumab IV Q4W Extension Open-Label

EXPERIMENTAL

Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

Drug: Mirikizumab

1000mg Mirikizumab IV Q4W Extension Open-Label

EXPERIMENTAL

Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.

Drug: Mirikizumab

200mg Mirikizumab SC Q4W Extension Open-Label

EXPERIMENTAL

Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label

Drug: Mirikizumab

Interventions

MirikizumabDRUG
Also known as: LY3074828
1000mg Mirikizumab IV Q4W Extension Open-Label200 mg Mirikizumab IV Q4W (induction)200 mg Mirikizumab SC Q12W (Maintenance)200 mg Mirikizumab SC Q4W (Maintenance)200mg Mirikizumab SC Q4W Extension Open-Label50 mg Mirikizumab IV Q4W (Induction)600 mg Mirikizumab IV Q4W (Induction)600mg Mirikizumab IV Q4W Extension Open-Label
PlaceboDRUG
Placebo IV Q4W (Induction)Placebo SC Q4W (Maintenance)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
  • Have evidence of UC extending proximal to the rectum (≥15 centimeters \[cm\] of involved colon)
  • Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor
  • Participants must either: be naive to biologic therapy (eg, tumor necrosis factor \[TNF\] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment

You may not qualify if:

  • Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
  • Have had surgery for treatment of UC or are likely to require surgery for UC during the study
  • Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

Precision Research Institute, LLC

Chula Vista, California, 91910, United States

Location

University of California - San Diego

La Jolla, California, 92093, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Borland Groover Clinic

Jacksonville, Florida, 32256 6004, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Delta Research Partners LLC

Monroe, Louisiana, 71201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States

Location

Care Access Research - Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

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Concord, 2139, Australia

Location

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Fitzroy, 3065, Australia

Location

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South Brisbane, 4101, Australia

Location

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Woolloongabba, 4102, Australia

Location

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Ghent, 9000, Belgium

Location

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Leuven, 3000, Belgium

Location

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Calgary, T2N 2T9, Canada

Location

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Calgary, t2n2z6, Canada

Location

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Montreal, H1T 2M4, Canada

Location

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Montreal, H3A 1A1, Canada

Location

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Montreal, H3G 1A4, Canada

Location

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Hradec Králové, 50012, Czechia

Location

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Prague, 140 21, Czechia

Location

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Prague, 14021, Czechia

Location

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Prague, 14059, Czechia

Location

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Prague, 17004, Czechia

Location

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Praha 4 Kralove, 14059, Czechia

Location

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Svendborg, 5700, Denmark

Location

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Clichy, 92110, France

Location

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Montpellier, 34295, France

Location

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Nice, 06202, France

Location

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Saint-Priest-en-Jarez, 42270, France

Location

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Vandœuvre-lès-Nancy, 54511, France

Location

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Tbilisi, 0112, Georgia

Location

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Békéscsaba, 5600, Hungary

Location

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Budapest, 1125, Hungary

Location

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Szeged, 6720, Hungary

Location

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Szekszárd, 7100, Hungary

Location

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Vác, 2600, Hungary

Location

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Bunkyō City, 113-8519, Japan

Location

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Chūōku, 060-0033, Japan

Location

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Kagoshima, 892-0846, Japan

Location

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Kamakura-shi, 247-0056, Japan

Location

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Kasugai-shi, 487-0031, Japan

Location

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Kawasaki, 210-0013, Japan

Location

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Mitaka, 181-8611, Japan

Location

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Nishinomiya, 663-8501, Japan

Location

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Osaka, 530-0011, Japan

Location

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Ōita, 870-0033, Japan

Location

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Saga, 840-8571, Japan

Location

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Sakura, 285-8741, Japan

Location

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Shinjuku-ku, 169-0073, Japan

Location

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Takasaki, 370-0829, Japan

Location

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Toyama, 930-8550, Japan

Location

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Toyota-shi, 470-1219, Japan

Location

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Tsu, 514-8507, Japan

Location

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Yokohama, 220-0045, Japan

Location

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Kaunas, LT-50009, Lithuania

Location

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Vilnius, 08661, Lithuania

Location

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Chisinau, MD2025, Moldova

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Bydgoszcz, 85-168, Poland

Location

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Elblag, 82-300, Poland

Location

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Katowice, 40 660, Poland

Location

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Krakow, 31009, Poland

Location

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Lublin, 20-582, Poland

Location

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Rzeszów, 35-068, Poland

Location

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Sopot, 81-756, Poland

Location

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Warsaw, 03 580, Poland

Location

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Warsaw, 03-580, Poland

Location

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Wroclaw, 53 114, Poland

Location

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Wroclaw, 53114, Poland

Location

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Bucharest, 020125, Romania

Location

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Oxford, OX3 9DU, United Kingdom

Location

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Winchester, S022 5DG, United Kingdom

Location

Related Publications (6)

  • Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.

    PMID: 37610533DERIVED

  • Johnson T, Steere B, Zhang P, Zang Y, Higgs R, Milch C, Reinisch W, Panes J, Huang K, D'Haens G, Krishnan V. Mirikizumab-Induced Transcriptome Changes in Ulcerative Colitis Patient Biopsies at Week 12 Are Maintained Through Week 52. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00630. doi: 10.14309/ctg.0000000000000630.

    PMID: 37594044DERIVED

  • Steere B, Schmitz J, Powell N, Higgs R, Gottlieb K, Liu Y, Jia B, Tuttle JL, Sandborn WJ, Sands BE, D'Haens G, Reinisch W, Krishnan V. Mirikizumab Regulates Genes Involved in Ulcerative Colitis Disease Activity and Anti-TNF Resistance: Results From a Phase 2 Study. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00578. doi: 10.14309/ctg.0000000000000578.

    PMID: 36881820DERIVED

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Related Links

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

December 9, 2015

Primary Completion

December 19, 2017

Study Completion

May 7, 2019

Last Updated

June 17, 2020

Results First Posted

May 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

MO(1)PL(11)FR(5)AU(4)NL(1)RO(1)BE(2)CZ(6)US(11)LI(2)GB(2)CA(5)JP(18)GE(1)DK(1)HU(5)