Clinical trial NCT02891226: A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: inflammatory bowel disease
IL-23
biologic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Endoscopic Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Endoscopic Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
timeFrame: Week 12
measure: Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
timeFrame: Baseline, Week 12
measure: Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline, Week 12
measure: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
timeFrame: 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
measure: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
timeFrame: 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
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Longwood Research
state: Alabama
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Garden Grove
country: United States
facility: Valley View Internal Medicine
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Delta Waves Sleep Disorders and Research Center
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Hialeah Gardens
country: United States
facility: Wellness Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Louisville
country: United States
facility: Robley Rex VAMC
state: Kentucky
city: Owensboro
country: United States
facility: Health Quest Medical Care
state: Kentucky
city: Monroe
country: United States
facility: Delta Research Partners LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Rosedale
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Health Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultant
state: Oklahoma
city: Lincoln
country: United States
facility: Ocean State Clinical Research Partners
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Richardson
country: United States
facility: Digestive Health Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: Salt Lake City
country: United States
facility: Care Access Research - Salt Lake City
state: Utah
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Health Services - Base Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
state: Victoria
city: Brussel
country: Belgium
facility: Hospital Universitaire Erasme Brussel
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Sudbury
country: Canada
facility: Sudbury Endoscopy Centre
state: Ontario
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Hepato-gastroenterologie HK, s.r.o.
city: Olomouc
country: Czechia
facility: Gregar s.r.o.
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova Nemocnice
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice v Motole
city: Zlin
country: Czechia
facility: Krajska nemocnice T. Bati a.s.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Vac
country: Hungary
facility: Javorszky Odon Hospital
city: Sakura-shi
country: Japan
facility: Toho University School of Medicine, Sakura Hospital
state: Chiba-Ken
city: Kitakyusyu-shi
country: Japan
facility: Kitakyushu Municipal Medical Center
state: Fukoka
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka-Ken
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
state: Kagoshima
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Takagi Clinic
state: Miyagi-Ken
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
state: Osaka-Fu
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Kyorin University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JHCO Tokyo Yamate Medical Center
state: Tokyo
city: Toyama-Shi
country: Japan
facility: Toyama Prefectural Central Hospital
state: Toyama
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Tilburg
country: Netherlands
facility: St Elisabeth Ziekenhuis
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Wroclaw
country: Poland
facility: Melita Medical Sp. Z O. O.
city: Oradea
country: Romania
facility: SC Pelican SRL
state: Bihor
city: Bucuresti
country: Romania
facility: SC Med Life SA
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBI Scientific Research Inst. of Physyology and Basic Medic
city: Omsk
country: Russian Federation
facility: Ultramed
city: Perm
country: Russian Federation
facility: City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
city: Pushkin
country: Russian Federation
facility: Private Medical Institution Evromedservis
city: Samara
country: Russian Federation
facility: Medical Institute REAVIZ
city: Samara
country: Russian Federation
facility: NonState Healthcare Institution Central Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Baltic Medicine
city: St. Petersburg
country: Russian Federation
facility: City Hospital of Saint Martyr Elizabeth
city: St. Petersburg
country: Russian Federation
facility: LLC Scientific Research Centre EKO-Bezopasnost
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
city: Lviv
country: Ukraine
facility: Lviv Regional Central Hospital
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Uzhgorod
country: Ukraine
facility: A. Novak Transcarpathian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
city: Vinnytsya
country: Ukraine
facility: Vinnitsa City Clinical Hospital #1
city: Zaporizhzhia
country: Ukraine
facility: City Clinical Hospital #6
city: Zaporizhzhia
country: Ukraine
facility: CI City Hospital #1
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.