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A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring inflammatory bowel disease, IL-23, biologic

Eligibility Criteria

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

Inclusion Criteria:

  • Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
  • Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

Exclusion Criteria:

  • Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
  • Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
  • Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
  • Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

Sites / Locations

  • Longwood Research
  • Del Sol Research Management, LLC
  • Valley View Internal Medicine
  • Ventura Clinical Trials
  • Delta Waves Sleep Disorders and Research Center
  • Medical Research Center of Connecticut
  • Clinical Research of West Florida
  • Wellness Clinical Research
  • University of Miami
  • Vista Health Research
  • Clinical Neuroscience Solutions Inc
  • Digestive Healthcare of Georgia
  • Columbus Regional Research Institute
  • Indiana University Health
  • Robley Rex VAMC
  • Health Quest Medical Care
  • Delta Research Partners LLC
  • Louisiana Research Center
  • MedStar Health Research Institute
  • University of Michigan Health Systems
  • Huron Gastroenterology Associates
  • Minnesota Gastroenterology, P.A.
  • Washington University Medical School
  • St. Louis Center for Clinical Research
  • Las Vegas Medical Research
  • Holy Name Medical Center
  • NYU Langone Long Island Clinical Research Associates
  • Columbia University Medical Center
  • University of North Carolina
  • Carolina Digestive Diseases
  • Consultants For Clinical Research
  • University Hospitals Health Center
  • University of Oklahoma Health Sciences Center
  • Healthcare Research Consultant
  • Ocean State Clinical Research Partners
  • Gastro One
  • Advanced Gastroenterology
  • Texas Clinical Research Institute, LLC
  • Hermann Drive Surgical Hospital
  • Digestive Health Associates of Texas
  • San Antonio Gastroenterology
  • Care Access Research - Salt Lake City
  • Virginia Mason Medical Center
  • University of Washington Medical Center
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Ballarat Health Services - Base Hospital
  • St Vincents Hospital Melbourne
  • Hospital Universitaire Erasme Brussel
  • Universitair Ziekenhuis Gent
  • Sudbury Endoscopy Centre
  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
  • Hepato-gastroenterologie HK, s.r.o.
  • Gregar s.r.o.
  • Thomayerova Nemocnice
  • Fakultni Nemocnice v Motole
  • Krajska nemocnice T. Bati a.s.
  • Obudai Egeszsegugyi Centrum Kft
  • Javorszky Odon Hospital
  • Toho University School of Medicine, Sakura Hospital
  • Kitakyushu Municipal Medical Center
  • Fukuoka University Chikushi Hospital
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • Sameshima Hospital
  • Gokeikai Ofuna Chuo Hospital
  • Takagi Clinic
  • Kinshukai Infusion Clinic
  • Tokyo Medical And Dental University Hospital
  • Kyorin University Hospital
  • JHCO Tokyo Yamate Medical Center
  • Toyama Prefectural Central Hospital
  • Fukuoka University Hospital
  • St Elisabeth Ziekenhuis
  • Academisch Medisch Centrum
  • Radboud Universitair Medisch Centrum Nijmegen
  • Erasmus Medisch Centrum
  • Szpital Uniwersytecki nr 2 im. dr J. Biziela
  • KO-MED Centra Kliniczne Lublin II
  • SOLUMED Centrum Medyczne
  • Korczowski Bartosz, Gabinet Lekarski
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Melita Medical Sp. Z O. O.
  • SC Pelican SRL
  • SC Med Life SA
  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • Novosibirsk State Medical University
  • FSBI Scientific Research Inst. of Physyology and Basic Medic
  • Ultramed
  • City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
  • Private Medical Institution Evromedservis
  • Medical Institute REAVIZ
  • NonState Healthcare Institution Central Clinical Hospital
  • Baltic Medicine
  • City Hospital of Saint Martyr Elizabeth
  • LLC Scientific Research Centre EKO-Bezopasnost
  • Ulyanovsk Regional Clinical Hospital
  • Universitätsspital Zürich
  • Kyiv Municipal Clinical Hospital #1
  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
  • Lviv Regional Central Hospital
  • Odesa Regional Clinical Hospital
  • A. Novak Transcarpathian Regional Clinical Hospital
  • SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
  • Vinnitsa City Clinical Hospital #1
  • City Clinical Hospital #6
  • CI City Hospital #1
  • Queen Elizabeth University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirikizumab

Placebo

Arm Description

Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W). Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1. Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.

Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Endoscopic Response at Week 12
Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; >2 cm = score 3); extent of ulcerated surface (none = 0; <10% = 1;10-30% = 2;>30% = 3);extent of affected surface (none = 0; <50% = 1;50-75% = 2;>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.

Secondary Outcome Measures

Percentage of Participants Achieving Endoscopic Remission at Week 12
Endoscopic remission defined as SES-CD of <4 ileal-colonic or <2 for isolated ileal disease, and no subscore >1 at week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: (ileum; right, transverse, and left colon; and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; greater than (>) 2 cm = score 3); extent of ulcerated surface (none = 0; less than (<) 10% = 1; 10-30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50-75% = 2; >75% = 3); and presence and type of narrowings (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
PRO remission is defined as stool frequency (SF) ≤2.5 and abdominal pain (AP) ≤1 and no worse than baseline at week 12. SF captures the number of liquid or very soft stools. AP score is classified as 0=none, 1=mild, 2=moderate, 3=severe.
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
The PGRS is a 1-item patient-rated questionnaire designed to assess the participant's rating of their disease symptom severity over the past 24 hours. Responses are graded on a 6-point scale in which a score of 1 indicates the subject has no symptoms (that is, "none") and a score of 6 indicates that the participant's symptom are "very severe." Least Squares Mean (LS Mean) was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
The PGRC scale is a patient-rated instrument designed to assess the participant's rating of change in their symptom(s). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the participant's symptom is "very much better," a score of 4 indicates that the participant's symptom has experienced "no change," and a score of 7 indicates that the participant's symptom is "very much worse."
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
The IBDQ is a 32-item self-administered questionnaire. The IBDQ has 4 dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). 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 Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0-4 associated with a range over "Not at all" to "Very much" for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains:physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
Population mean (between-subject coefficient variance [CV %]) apparent clearance. Clearance is estimated based on concentration data collected in the time frame of 0-208 weeks.
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
Population mean (between-subject coefficient variance [CV %]) apparent volume of distribution. Volume of distribution is estimated based on concentration data collected in the time frame of 0-208 weeks.

Full Information

First Posted
September 1, 2016
Last Updated
August 1, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02891226
Brief Title
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
Acronym
SERENITY
Official Title
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
inflammatory bowel disease, IL-23, biologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirikizumab
Arm Type
Experimental
Arm Description
Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W). Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1. Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Response at Week 12
Description
Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; >2 cm = score 3); extent of ulcerated surface (none = 0; <10% = 1;10-30% = 2;>30% = 3);extent of affected surface (none = 0; <50% = 1;50-75% = 2;>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Remission at Week 12
Description
Endoscopic remission defined as SES-CD of <4 ileal-colonic or <2 for isolated ileal disease, and no subscore >1 at week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: (ileum; right, transverse, and left colon; and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; greater than (>) 2 cm = score 3); extent of ulcerated surface (none = 0; less than (<) 10% = 1; 10-30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50-75% = 2; >75% = 3); and presence and type of narrowings (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.
Time Frame
Week 12
Title
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
Description
PRO remission is defined as stool frequency (SF) ≤2.5 and abdominal pain (AP) ≤1 and no worse than baseline at week 12. SF captures the number of liquid or very soft stools. AP score is classified as 0=none, 1=mild, 2=moderate, 3=severe.
Time Frame
Week 12
Title
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
Description
The PGRS is a 1-item patient-rated questionnaire designed to assess the participant's rating of their disease symptom severity over the past 24 hours. Responses are graded on a 6-point scale in which a score of 1 indicates the subject has no symptoms (that is, "none") and a score of 6 indicates that the participant's symptom are "very severe." Least Squares Mean (LS Mean) was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Time Frame
Baseline, Week 12
Title
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
Description
The PGRC scale is a patient-rated instrument designed to assess the participant's rating of change in their symptom(s). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the participant's symptom is "very much better," a score of 4 indicates that the participant's symptom has experienced "no change," and a score of 7 indicates that the participant's symptom is "very much worse."
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
Description
The IBDQ is a 32-item self-administered questionnaire. The IBDQ has 4 dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). 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 Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Description
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0-4 associated with a range over "Not at all" to "Very much" for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12
Description
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains:physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.
Time Frame
Baseline, Week 12
Title
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
Description
Population mean (between-subject coefficient variance [CV %]) apparent clearance. Clearance is estimated based on concentration data collected in the time frame of 0-208 weeks.
Time Frame
Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion
Title
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
Description
Population mean (between-subject coefficient variance [CV %]) apparent volume of distribution. Volume of distribution is estimated based on concentration data collected in the time frame of 0-208 weeks.
Time Frame
Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain. Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD. Exclusion Criteria: Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy. Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome. Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening. Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.
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
Longwood Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Valley View Internal Medicine
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Ventura Clinical Trials
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Delta Waves Sleep Disorders and Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Medical Research Center of Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Wellness Clinical Research
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Robley Rex VAMC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Health Quest Medical Care
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Delta Research Partners LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Louisiana Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
MedStar Health Research Institute
City
Rosedale
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
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
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolina Digestive Diseases
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Consultants For Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Health Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Healthcare Research Consultant
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Ocean State Clinical Research Partners
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Advanced Gastroenterology
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38261
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Hermann Drive Surgical Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Digestive Health Associates of Texas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
San Antonio Gastroenterology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6424
Country
United States
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ballarat Health Services - Base Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Hospital Universitaire Erasme Brussel
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Sudbury Endoscopy Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 5K6
Country
Canada
Facility Name
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
City
Usti nad Labem
State/Province
Czech Republic
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Hepato-gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Gregar s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Thomayerova Nemocnice
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Krajska nemocnice T. Bati a.s.
City
Zlin
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Javorszky Odon Hospital
City
Vac
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Toho University School of Medicine, Sakura Hospital
City
Sakura-shi
State/Province
Chiba-Ken
ZIP/Postal Code
285 8471
Country
Japan
Facility Name
Kitakyushu Municipal Medical Center
City
Kitakyusyu-shi
State/Province
Fukoka
ZIP/Postal Code
802-0077
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
818 8502
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060 0033
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Gokeikai Ofuna Chuo Hospital
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Takagi Clinic
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
981 3213
Country
Japan
Facility Name
Kinshukai Infusion Clinic
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Tokyo Medical And Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
JHCO Tokyo Yamate Medical Center
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama-Shi
State/Province
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
St Elisabeth Ziekenhuis
City
Tilburg
State/Province
Noord Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Radboud Universitair Medisch Centrum Nijmegen
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Szpital Uniwersytecki nr 2 im. dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
KO-MED Centra Kliniczne Lublin II
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warszawa
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Melita Medical Sp. Z O. O.
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
SC Pelican SRL
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
SC Med Life SA
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
FSBI Scientific Research Inst. of Physyology and Basic Medic
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
Ultramed
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
City
Perm
ZIP/Postal Code
614068
Country
Russian Federation
Facility Name
Private Medical Institution Evromedservis
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Medical Institute REAVIZ
City
Samara
ZIP/Postal Code
443001
Country
Russian Federation
Facility Name
NonState Healthcare Institution Central Clinical Hospital
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Baltic Medicine
City
St. Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
City Hospital of Saint Martyr Elizabeth
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
LLC Scientific Research Centre EKO-Bezopasnost
City
St. Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kyiv Municipal Clinical Hospital #1
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Lviv Regional Central Hospital
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65117
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
City
Vinnytsia
ZIP/Postal Code
21030
Country
Ukraine
Facility Name
Vinnitsa City Clinical Hospital #1
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
City Clinical Hospital #6
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhzhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
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
34748774
Citation
Sands BE, Peyrin-Biroulet L, Kierkus J, Higgins PDR, Fischer M, Jairath V, Hirai F, D'Haens G, Belin RM, Miller D, Gomez-Valderas E, Naegeli AN, Tuttle JL, Pollack PF, Sandborn WJ. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology. 2022 Feb;162(2):495-508. doi: 10.1053/j.gastro.2021.10.050. Epub 2021 Nov 5.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5IDfzP6WruCqkOq0OokSSe
Description
A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

Learn more about this trial

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

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