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A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mirikizumab

Placebo

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring IL-23 antibody

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Precision Research Institute, LLC
University of California - San Diego
Inland Empire Liver Foundation
Borland Groover Clinic
University of Chicago Medical Center
Delta Research Partners LLC
University of Michigan
Minnesota Gastroenterology, P.A.
Columbia University Medical Center
Carolinas Healthcare System
Care Access Research - Salt Lake City
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

50 mg Mirikizumab IV Q4W (Induction)

200 mg Mirikizumab IV Q4W (induction)

600 mg Mirikizumab IV Q4W (Induction)

Placebo IV Q4W (Induction)

200 mg Mirikizumab SC Q4W (Maintenance)

200 mg Mirikizumab SC Q12W (Maintenance)

Placebo SC Q4W (Maintenance)

600mg Mirikizumab IV Q4W Extension Open-Label

1000mg Mirikizumab IV Q4W Extension Open-Label

200mg Mirikizumab SC Q4W Extension Open-Label

Arm Description

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.

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.

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.

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Clinical response at week 12 is defined as a decrease in the 9-point Mayo subscores (rectal bleeding, stool frequency and the endoscopic findings) inclusive of >= 2 points and >=35% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four 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) 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). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.

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

Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic score of 0 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 total score ranges from 0 to 3 points, with higher scores representing more severe disease.

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

Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 at Week 52. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 3 points, with higher scores representing more severe disease.

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

The IBDQ is a 32-item subject-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. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).

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

SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. LS Mean was calculated using Mixed effect Model Repeat Measurement (MMRM) model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).

Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score

PGI-S is a 1-item subject-rated questionnaire designed to assess the subject's impression of their disease symptoms at baseline (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point scale in which a score of 1 indicates that the subject's symptom(s) are "normal," a score of 2 indicates that the subject feels "borderline ill," a score of 3 indicates that the subject feels "mildly ill," a score of 4 indicates that the subject(s) feel "moderately ill," and scores of 5, 6, and 7 indicate that the subject feels "markedly ill," "severely ill," and "extremely ill," respectively. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).

Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12

PGI-I scale is a subject-rated instrument designed to assess the subject's impression of change in their symptom(s) (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the subject's symptom(s) is "very much better," a score of 4 indicates that the subject's symptom(s) has experienced "no change," and a score of 7 indicates that the subject's symptom(s) is "very much worse."

Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab

Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab

Induction Period: Percentage of Participants With Symptomatic Remission at Week 12

Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. Stool Frequency Subscore is 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 is based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.

Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52

Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. 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 zero (normal) to 3 (severe disease). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.

Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12

Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.

Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52

Full Information

NCT ID

NCT02589665

First Posted

October 27, 2015

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02589665

Brief Title

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 9, 2015 (Actual)

Primary Completion Date

December 19, 2017 (Actual)

Study Completion Date

May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

IL-23 antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg Mirikizumab IV Q4W (Induction)

Arm Type

Experimental

Arm Description

Arm Title

200 mg Mirikizumab IV Q4W (induction)

Arm Type

Experimental

Arm Description

Arm Title

600 mg Mirikizumab IV Q4W (Induction)

Arm Type

Experimental

Arm Description

Arm Title

Placebo IV Q4W (Induction)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

200 mg Mirikizumab SC Q4W (Maintenance)

Arm Type

Experimental

Arm Description

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

Arm Title

200 mg Mirikizumab SC Q12W (Maintenance)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo SC Q4W (Maintenance)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

600mg Mirikizumab IV Q4W Extension Open-Label

Arm Type

Experimental

Arm Description

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

Arm Title

1000mg Mirikizumab IV Q4W Extension Open-Label

Arm Type

Experimental

Arm Description

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

Arm Title

200mg Mirikizumab SC Q4W Extension Open-Label

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mirikizumab

Other Intervention Name(s)

LY3074828

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 12

Title

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

Description

Time Frame

Week 52

Title

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

Description

Time Frame

Baseline, Week 12

Title

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

Description

Time Frame

Baseline, Week 12

Title

Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score

Description

Time Frame

Baseline, Week 12

Title

Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12

Description

Time Frame

Week 12

Title

Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab

Description

Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab

Time Frame

Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d

Title

Induction Period: Percentage of Participants With Symptomatic Remission at Week 12

Description

Time Frame

Week 12

Title

Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52

Description

Time Frame

Week 52

Title

Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12

Description

Time Frame

Week 12

Title

Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52

Description

Time Frame

Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Precision Research Institute, LLC

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

University of California - San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Inland Empire Liver Foundation

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Borland Groover Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256 6004

Country

United States

Facility Name

University of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Delta Research Partners LLC

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Minnesota Gastroenterology, P.A.

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55446

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Carolinas Healthcare System

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Care Access Research - Salt Lake City

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Concord

ZIP/Postal Code

2139

Country

Australia

Facility Name

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Calgary

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

City

Calgary

ZIP/Postal Code

t2n2z6

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

City

Montréal

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

City

Hradec Kralove

ZIP/Postal Code

50012

Country

Czechia

Facility Name

City

Hradec Králové

ZIP/Postal Code

50012

Country

Czechia

Facility Name

City

Praha 4 Kralove

ZIP/Postal Code

14059

Country

Czechia

Facility Name

City

Praha 4

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

City

Praha 4

ZIP/Postal Code

14059

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

14021

Country

Czechia

Facility Name

City

Praha

ZIP/Postal Code

17004

Country

Czechia

Facility Name

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

City

Saint Priest en Jarez

ZIP/Postal Code

42270

Country

France

Facility Name

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

City

Vac

ZIP/Postal Code

2600

Country

Hungary

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

City

Chuo-ku

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

City

Kagoshima-shi

ZIP/Postal Code

892-0846

Country

Japan

Facility Name

City

Kamakura-shi

ZIP/Postal Code

247-0056

Country

Japan

Facility Name

City

Kasugai-shi

ZIP/Postal Code

487-0031

Country

Japan

Facility Name

City

Kawasaki

ZIP/Postal Code

210-0013

Country

Japan

Facility Name

City

Mitaka

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

City

Nishinomiya

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

City

Oita City

ZIP/Postal Code

870-0033

Country

Japan

Facility Name

City

Osaka-City

ZIP/Postal Code

530-0011

Country

Japan

Facility Name

City

Saga-shi

ZIP/Postal Code

840-8571

Country

Japan

Facility Name

City

Sakura

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

City

Shinjuku-ku

ZIP/Postal Code

169-0073

Country

Japan

Facility Name

City

Takasaki

ZIP/Postal Code

370-0829

Country

Japan

Facility Name

City

Toyama

ZIP/Postal Code

930-8550

Country

Japan

Facility Name

City

Toyota-shi

ZIP/Postal Code

470-1219

Country

Japan

Facility Name

City

Tsu-shi

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

City

Yokohama

ZIP/Postal Code

220-0045

Country

Japan

Facility Name

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

City

Chisinau

ZIP/Postal Code

MD2025

Country

Moldova, Republic of

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Katowice

ZIP/Postal Code

40 660

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

31009

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

City

Rzeszow

ZIP/Postal Code

35-068

Country

Poland

Facility Name

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

03 580

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

03-580

Country

Poland

Facility Name

City

Wroclaw

ZIP/Postal Code

53 114

Country

Poland

Facility Name

City

Wrocław

ZIP/Postal Code

53114

Country

Poland

Facility Name

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

City

Winchester

ZIP/Postal Code

S022 5DG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

32950748

Citation

Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.

Results Reference

derived

PubMed Identifier

31493397

Citation

Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.

Results Reference

derived

Learn more about this trial

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

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