A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
SERENITY
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY)
3 other identifiers
interventional
191
14 countries
108
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2016
Typical duration for phase_2
108 active sites
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
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedStudy Start
First participant enrolled
December 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2021
CompletedResults Posted
Study results publicly available
February 28, 2022
CompletedAugust 30, 2022
August 1, 2022
2 years
September 1, 2016
February 2, 2022
August 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 12
Secondary Outcomes (9)
Percentage of Participants Achieving Endoscopic Remission at Week 12
Week 12
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
Week 12
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
Baseline, Week 12
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
Baseline, Week 12
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
Baseline, Week 12
- +4 more secondary outcomes
Study Arms (2)
Mirikizumab
EXPERIMENTALPeriod 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.
Placebo
PLACEBO COMPARATORPeriod 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (108)
Longwood Research
Huntsville, Alabama, 35801, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85710, United States
Valley View Internal Medicine
Garden Grove, California, 92843, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, 80918, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Wellness Clinical Research
Hialeah Gardens, Florida, 33012, United States
University of Miami
Miami, Florida, 33136, United States
Vista Health Research
Miami, Florida, 33176, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Robley Rex VAMC
Louisville, Kentucky, 40206, United States
Health Quest Medical Care
Owensboro, Kentucky, 42303, United States
Delta Research Partners LLC
Monroe, Louisiana, 71201, United States
Louisiana Research Center
Shreveport, Louisiana, 71105, United States
MedStar Health Research Institute
Rosedale, Maryland, 21237, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Consultants For Clinical Research
Cincinnati, Ohio, 45219, United States
University Hospitals Health Center
Cleveland, Ohio, 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Healthcare Research Consultant
Tulsa, Oklahoma, 74135, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865, United States
Gastro One
Germantown, Tennessee, 38138, United States
Advanced Gastroenterology
Union City, Tennessee, 38261, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
Digestive Health Associates of Texas
Richardson, Texas, 75082, United States
San Antonio Gastroenterology
San Antonio, Texas, 78229, United States
Care Access Research - Salt Lake City
Salt Lake City, Utah, 84124, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Washington Medical Center
Seattle, Washington, 98195-6424, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Ballarat Health Services - Base Hospital
Ballarat, Victoria, 3350, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Hospital Universitaire Erasme Brussel
Brussels, 1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Sudbury Endoscopy Centre
Greater Sudbury, Ontario, P3C 5K6, Canada
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Czech Republic, 40113, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
Gregar s.r.o.
Olomouc, 779 00, Czechia
Fakultni Nemocnice v Motole
Prague, 150 06, Czechia
Thomayerova Nemocnice
Praha 4 - Krc, 140 59, Czechia
Krajska nemocnice T. Bati a.s.
Zlín, 76275, Czechia
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Javorszky Odon Hospital
Vác, 2600, Hungary
Toho University School of Medicine, Sakura Hospital
Sakura-shi, Chiba, 285 8471, Japan
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, 802-0077, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818 8502, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060 0033, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056, Japan
Takagi Clinic
Sendai, Miyagi, 981 3213, Japan
Kinshukai Infusion Clinic
Osaka, Osaka, 530-0011, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073, Japan
Toyama Prefectural Central Hospital
Toyama, Toyama, 930-8550, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
St Elisabeth Ziekenhuis
Tilburg, North Brabant, 5022 GC, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Radboud Universitair Medisch Centrum Nijmegen
Nijmegen, 6525, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, 85-168, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632, Poland
Melita Medical Sp. Z O. O.
Wroclaw, 50-449, Poland
SC Pelican SRL
Oradea, Bihor County, 410469, Romania
SC Med Life SA
Bucharest, 010719, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
Novosibirsk State Medical University
Novosibirsk, 630091, Russia
FSBI Scientific Research Inst. of Physyology and Basic Medic
Novosibirsk, 630117, Russia
Ultramed
Omsk, 644024, Russia
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
Perm, 614068, Russia
Private Medical Institution Evromedservis
Pushkin, 196603, Russia
Baltic Medicine
Saint Petersburg, 194356, Russia
City Hospital of Saint Martyr Elizabeth
Saint Petersburg, 195257, Russia
LLC Scientific Research Centre EKO-Bezopasnost
Saint Petersburg, 196143, Russia
Medical Institute REAVIZ
Samara, 443001, Russia
NonState Healthcare Institution Central Clinical Hospital
Samara, 443041, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063, Russia
Universitätsspital Zürich
Zurich, 8091, Switzerland
Kyiv Municipal Clinical Hospital #1
Kyiv, 02091, Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04107, Ukraine
Lviv Regional Central Hospital
Lviv, 79010, Ukraine
Odesa Regional Clinical Hospital
Odesa, 65117, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88018, Ukraine
Vinnitsa City Clinical Hospital #1
Vinnytsia, 21005, Ukraine
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
Vinnytsia, 21030, Ukraine
City Clinical Hospital #6
Zaporizhzhia, 69035, Ukraine
CI City Hospital #1
Zaporizhzhia, 69104, Ukraine
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Related Publications (2)
Magro F, Protic M, De Hertogh G, Chan LS, Pollack P, Jairath V, Carlier H, Hon E, Feagan BG, Harpaz N, Pai R, Reinisch W. Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1878-1888.e10. doi: 10.1016/j.cgh.2023.11.010. Epub 2023 Nov 20.
PMID: 37993033DERIVEDSands 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.
PMID: 34748774DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
September 1, 2016
First Posted
September 7, 2016
Study Start
December 14, 2016
Primary Completion
December 11, 2018
Study Completion
February 5, 2021
Last Updated
August 30, 2022
Results First Posted
February 28, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- 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.
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.