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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891226
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Mirikizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
Actual Study Start Date : December 14, 2016
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Mirikizumab Dose Level 1

Period 1 (Weeks 0 -12) Mirikizumab dose level 1

Period 2 (Weeks 12 - 52) Mirikizumab dose level 1 or dose level 4 or dose level 3

Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Drug: Mirikizumab
Other Name: LY3074828

Experimental: Mirikizumab Dose Level 2

Period 1 (Weeks 0 -12) Mirikizumab dose level 2

Period 2 (Weeks 12 - 52) Mirikizumab dose level 2 or dose level 4 or dose level 3

Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Drug: Mirikizumab
Other Name: LY3074828

Experimental: Mirikizumab Dose Level 3

Period 1 (Weeks 0 -12) Mirikizumab dose level 3

Period 2 (Weeks 12 - 52) Mirikizumab dose level 3 or dose level 4

Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Drug: Mirikizumab
Other Name: LY3074828

Placebo Comparator: Placebo

Period 1 (Weeks 0 -12) Placebo

Period 2 (Weeks 12 - 52) Mirikizumab dose level 3

Period 3 (Weeks 52 - 104) Mirikizumab dose level 4

Drug: Mirikizumab
Other Name: LY3074828

Drug: Placebo



Primary Outcome Measures :
  1. Proportion of Participants Achieving 50% Reduction from Baseline on the Simple Endoscopic Activity Score-Crohn's Disease (SES-CD) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Discontinuation Rate [ Time Frame: Baseline through Week 104 ]
  2. Proportion of Participants Achieving Endoscopic Remission [ Time Frame: Week 12 ]
  3. Proportion of Participants Achieving Patient Report Outcome Remission [ Time Frame: Week 12 ]
  4. Mean Change from Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  5. Mean Change from Baseline on the Patient Global Rating - Change (PGRC) Crohn's Disease Score [ Time Frame: Baseline, Week 12 ]
  6. Mean Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 12 ]
  7. Mean Change from Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline, Week 12 ]
  8. Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Score [ Time Frame: Baseline, Week 12 ]
  9. Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Week 104 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891226


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Locations
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United States, Alabama
Longwood Research
Huntsville, Alabama, United States, 35801
United States, Arizona
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85710
United States, California
Valley View Internal Medicine
Garden Grove, California, United States, 92843
Ventura Clinical Trials
Ventura, California, United States, 93003
United States, Colorado
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, United States, 80918
United States, Connecticut
Medical Research Center of Connecticut
Hamden, Connecticut, United States, 06518
United States, Florida
Clinical Research of West Florida
Clearwater, Florida, United States, 33765
Wellness Clinical Research
Hialeah Gardens, Florida, United States, 33012
University of Miami
Miami, Florida, United States, 33136
Vista Health Research
Miami, Florida, United States, 33176
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States, 32801
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Robley Rex VAMC
Louisville, Kentucky, United States, 40206
Health Quest Medical Care
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Delta Research Partners LLC
Monroe, Louisiana, United States, 71201
Louisiana Research Center
Shreveport, Louisiana, United States, 71105
United States, Maryland
MedStar Health Research Institute
Rosedale, Maryland, United States, 21237
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States, 55446
United States, Missouri
Washington University Medical School
Saint Louis, Missouri, United States, 63110
St. Louis Center for Clinical Research
Saint Louis, Missouri, United States, 63128
United States, Nevada
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolina Digestive Diseases
Greenville, North Carolina, United States, 27834
United States, Ohio
Consultants For Clinical Research
Cincinnati, Ohio, United States, 45219
University Hospitals Health Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Healthcare Research Consultant
Tulsa, Oklahoma, United States, 74135
United States, Rhode Island
Ocean State Clinical Research Partners
Lincoln, Rhode Island, United States, 02865
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Advanced Gastroenterology
Union City, Tennessee, United States, 38261
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Hermann Drive Surgical Hospital
Houston, Texas, United States, 77004
Digestive Health Associates of Texas
Richardson, Texas, United States, 75082
San Antonio Gastroenterology
San Antonio, Texas, United States, 78229
United States, Utah
Care Access Research - Salt Lake City
Salt Lake City, Utah, United States, 84124
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington Medical Center
Seattle, Washington, United States, 98195-6424
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Ballarat Health Services - Base Hospital
Ballarat, Victoria, Australia, 3350
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Belgium
Hospital Universitaire Erasme Brussel
Brussel, Belgium, 1070
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Canada, Ontario
Sudbury Endoscopy Centre
Sudbury, Ontario, Canada, P3C 5K6
Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Usti nad Labem, Czech Republic, Czechia, 40113
Hepato-gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 50012
Gregar s.r.o.
Olomouc, Czechia, 779 00
Thomayerova Nemocnice
Praha 4 - Krc, Czechia, 140 59
Fakultni Nemocnice v Motole
Praha 5, Czechia, 150 06
Krajska nemocnice T. Bati a.s.
Zlin, Czechia, 76275
Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, Hungary, 1036
Javorszky Odon Hospital
Vac, Hungary, 2600
Japan
Toho University School of Medicine, Sakura Hospital
Sakura-shi, Chiba-Ken, Japan, 285 8471
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, Japan, 802-0077
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka-Ken, Japan, 818 8502
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo-shi, Hokkaido, Japan, 060 0033
Sameshima Hospital
Kagoshima-shi, Kagoshima, Japan, 892-0846
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, Japan, 247-0056
Takagi Clinic
Sendai-shi, Miyagi-Ken, Japan, 981 3213
Kinshukai Infusion Clinic
Osaka-shi, Osaka-Fu, Japan, 530-0011
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8519
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan, 169-0073
Toyama Prefectural Central Hospital
Toyama-Shi, Toyama, Japan, 930-8550
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Netherlands
St Elisabeth Ziekenhuis
Tilburg, Noord Brabant, Netherlands, 5022 GC
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Radboud Universitair Medisch Centrum Nijmegen
Nijmegen, Netherlands, 6525
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, Poland, 85-168
KO-MED Centra Kliniczne Lublin II
Lublin, Poland, 20-362
SOLUMED Centrum Medyczne
Poznan, Poland, 60-529
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, Poland, 35-302
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, Poland, 71-434
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warszawa, Poland, 00-632
Melita Medical Sp. Z O. O.
Wroclaw, Poland, 50-449
Romania
SC Pelican SRL
Oradea, Bihor, Romania, 410469
SC Med Life SA
Bucuresti, Romania, 010719
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timisoara, Romania, 300002
Russian Federation
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
FSBI Scientific Research Inst. of Physyology and Basic Medic
Novosibirsk, Russian Federation, 630117
Ultramed
Omsk, Russian Federation, 644024
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
Perm, Russian Federation, 614068
Private Medical Institution Evromedservis
Pushkin, Russian Federation, 196603
Medical Institute REAVIZ
Samara, Russian Federation, 443001
NonState Healthcare Institution Central Clinical Hospital
Samara, Russian Federation, 443041
Baltic Medicine
St. Petersburg, Russian Federation, 194356
City Hospital of Saint Martyr Elizabeth
St. Petersburg, Russian Federation, 195257
LLC Scientific Research Centre EKO-Bezopasnost
St. Petersburg, Russian Federation, 196143
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russian Federation, 432063
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Ukraine
Kyiv Municipal Clinical Hospital #1
Kyiv, Ukraine, 02091
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, Ukraine, 04107
Lviv Regional Central Hospital
Lviv, Ukraine, 79010
Odesa Regional Clinical Hospital
Odesa, Ukraine, 65117
A. Novak Transcarpathian Regional Clinical Hospital
Uzhgorod, Ukraine, 88018
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
Vinnytsia, Ukraine, 21030
Vinnitsa City Clinical Hospital #1
Vinnytsya, Ukraine, 21005
City Clinical Hospital #6
Zaporizhzhia, Ukraine, 69035
CI City Hospital #1
Zaporizhzhia, Ukraine, 69104
United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02891226     History of Changes
Other Study ID Numbers: 16492
I6T-MC-AMAG ( Other Identifier: Eli Lilly and Company )
2016-002204-84 ( EudraCT Number )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
inflammatory bowel disease
IL-23
biologic
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases