A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
- Registration Number
- NCT02891226
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W. Mirikizumab Mirikizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Endoscopic Response at Week 12 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
Name Time Method Percentage of Participants Achieving Endoscopic Remission at Week 12 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 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 Baseline, 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 Baseline, 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 Baseline, 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 Baseline, 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 Baseline, 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 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 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 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 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.
Trial Locations
- Locations (108)
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Consultants For Clinical Research
🇺🇸Cincinnati, Ohio, United States
Longwood Research
🇺🇸Huntsville, Alabama, United States
Wellness Clinical Research
🇺🇸Hialeah Gardens, Florida, United States
Delta Research Partners LLC
🇺🇸Monroe, Louisiana, United States
Huron Gastroenterology Associates
🇺🇸Ypsilanti, Michigan, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Ventura Clinical Trials
🇺🇸Ventura, California, United States
Ocean State Clinical Research Partners
🇺🇸Lincoln, Rhode Island, United States
Delta Waves Sleep Disorders and Research Center
🇺🇸Colorado Springs, Colorado, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
NYU Langone Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
University Hospitals Health Center
🇺🇸Cleveland, Ohio, United States
Hermann Drive Surgical Hospital
🇺🇸Houston, Texas, United States
Radboud Universitair Medisch Centrum Nijmegen
🇳🇱Nijmegen, Netherlands
Valley View Internal Medicine
🇺🇸Garden Grove, California, United States
Kitakyushu Municipal Medical Center
🇯🇵Kitakyusyu-shi, Fukoka, Japan
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
Ultramed
🇷🇺Omsk, Russian Federation
Health Quest Medical Care
🇺🇸Owensboro, Kentucky, United States
Thomayerova Nemocnice
🇨🇿Praha 4 - Krc, Czechia
Minnesota Gastroenterology, P.A.
🇺🇸Plymouth, Minnesota, United States
Obudai Egeszsegugyi Centrum Kft
🇭🇺Budapest, Hungary
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Advanced Gastroenterology
🇺🇸Union City, Tennessee, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Toho University School of Medicine, Sakura Hospital
🇯🇵Sakura-shi, Chiba-Ken, Japan
Healthcare Research Consultant
🇺🇸Tulsa, Oklahoma, United States
Hospital Universitaire Erasme Brussel
🇧🇪Brussel, Belgium
A. Novak Transcarpathian Regional Clinical Hospital
🇺🇦Uzhgorod, Ukraine
Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
Medical Institute REAVIZ
🇷🇺Samara, Russian Federation
Gastro One
🇺🇸Germantown, Tennessee, United States
Sudbury Endoscopy Centre
🇨🇦Sudbury, Ontario, Canada
NonState Healthcare Institution Central Clinical Hospital
🇷🇺Samara, Russian Federation
Fukuoka University Chikushi Hospital
🇯🇵Chikushino-shi, Fukuoka-Ken, Japan
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
🇨🇿Usti nad Labem, Czech Republic, Czechia
Krajska nemocnice T. Bati a.s.
🇨🇿Zlin, Czechia
Fakultni Nemocnice v Motole
🇨🇿Praha 5, Czechia
Kyiv Municipal Clinical Hospital #1
🇺🇦Kyiv, Ukraine
KO-MED Centra Kliniczne Lublin II
🇵🇱Lublin, Poland
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
🇺🇦Vinnytsia, Ukraine
Sameshima Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Baltic Medicine
🇷🇺St. Petersburg, Russian Federation
City Hospital of Saint Martyr Elizabeth
🇷🇺St. Petersburg, Russian Federation
Takagi Clinic
🇯🇵Sendai-shi, Miyagi-Ken, Japan
Hepato-gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
SOLUMED Centrum Medyczne
🇵🇱Poznan, Poland
SC Med Life SA
🇷🇴Bucuresti, Romania
Lviv Regional Central Hospital
🇺🇦Lviv, Ukraine
Vinnitsa City Clinical Hospital #1
🇺🇦Vinnytsya, Ukraine
CI City Hospital #1
🇺🇦Zaporizhzhia, Ukraine
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
City Clinical Hospital #6
🇺🇦Zaporizhzhia, Ukraine
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
🇷🇺Perm, Russian Federation
Private Medical Institution Evromedservis
🇷🇺Pushkin, Russian Federation
Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
University of Miami
🇺🇸Miami, Florida, United States
SC Pelican SRL
🇷🇴Oradea, Bihor, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
🇷🇴Timisoara, Romania
JHCO Tokyo Yamate Medical Center
🇯🇵Shinjuku-ku, Tokyo, Japan
Javorszky Odon Hospital
🇭🇺Vac, Hungary
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Tokyo Medical And Dental University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Szpital Uniwersytecki nr 2 im. dr J. Biziela
🇵🇱Bydgoszcz, Poland
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Care Access Research - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Gokeikai Ofuna Chuo Hospital
🇯🇵Kamakura-shi, Kanagawa, Japan
Kinshukai Infusion Clinic
🇯🇵Osaka-shi, Osaka-Fu, Japan
Ulyanovsk Regional Clinical Hospital
🇷🇺Ulyanovsk, Russian Federation
Vista Health Research
🇺🇸Miami, Florida, United States
MedStar Health Research Institute
🇺🇸Rosedale, Maryland, United States
San Antonio Gastroenterology
🇺🇸San Antonio, Texas, United States
Digestive Health Associates of Texas
🇺🇸Richardson, Texas, United States
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Gregar s.r.o.
🇨🇿Olomouc, Czechia
St Elisabeth Ziekenhuis
🇳🇱Tilburg, Noord Brabant, Netherlands
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Toyama Prefectural Central Hospital
🇯🇵Toyama-Shi, Toyama, Japan
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Centrum Zdrowia Matki, Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszow, Poland
Melita Medical Sp. Z O. O.
🇵🇱Wroclaw, Poland
FSBI Scientific Research Inst. of Physyology and Basic Medic
🇷🇺Novosibirsk, Russian Federation
LLC Scientific Research Centre EKO-Bezopasnost
🇷🇺St. Petersburg, Russian Federation
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
🇺🇦Kyiv, Ukraine
Washington University Medical School
🇺🇸Saint Louis, Missouri, United States
Ballarat Health Services - Base Hospital
🇦🇺Ballarat, Victoria, Australia
Medical Research Center of Connecticut
🇺🇸Hamden, Connecticut, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Robley Rex VAMC
🇺🇸Louisville, Kentucky, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Clinical Neuroscience Solutions Inc
🇺🇸Orlando, Florida, United States
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
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