An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03518086
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV

Study Details

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Key Dates

First listed
May 8, 2018
Start date
Jun 18, 2018
Status verified
May 2025
Primary completion
Jan 21, 2021
Completion
May 15, 2024

Study Design

Enrollment
1,281 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
    Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Experimental: 300 Milligram (mg) Mirikizumab IV Q4W
    300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Placebo Comparator: Placebo IV Q4W Maximum Extended Enrollment (ME2)
    Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
  • Experimental: 300 mg Mirikizumab IV Q4W ME2
    300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Primary Outcome Measure

Percentage of Participants With Clinical Remission at Week 12 [ Time Frame: Week 12 ]

Locations (98)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Dcr-Pi, PcLitchfield ParkArizona85340-
Maricopa Integrated Health SystemPhoenixArizona85008-
Physicians Research GroupTempeArizona85284-
Yuma Gastro LLCYumaArizona85364-
Valley GastroenterologyArcadiaCalifornia91006-
Care Access ResearchBerkeleyCalifornia94705-
Citrus Valley Health PartnersCovinaCalifornia91722-
Valley View Internal MedicineGarden GroveCalifornia92843-
Om Research, LLCLancasterCalifornia93534-
Catalina Research Institute, LLCMontclairCalifornia91763-
California Medical Research AssociatesNorthridgeCalifornia91324-
Gastroenterology AssociatesPasadenaCalifornia91105-
Clinical Applications Laboratories, Inc.San DiegoCalifornia92103-
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158-
University of ColoradoAuroraColorado80045-
Delta Waves Sleep Disorders and Research CenterColorado SpringsColorado80918-
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765-
Gastroenterology Consultants of ClearwaterClearwaterFlorida33756-
West Central Gastroenterology d/b/a Gastro FloridaClearwaterFlorida33761-
Pioneer Clinical ResearchCoral SpringsFlorida33067-
Direct Helpers Medical CenterHialeahFlorida33012-
The Center for Gastrointestinal DisordersHollywoodFlorida33021-
Nature Coast Clinical Research, LLCInvernessFlorida34452-
SIH Research, LLCKissimmeeFlorida34741-
Columbus Clinical Services, LLCMiamiFlorida33125-
IMIC, Inc.MiamiFlorida33176-
Research Associates of South Florida, LLCMiamiFlorida33134-
Inpatient Research Clinic, LLCMiami LakesFlorida33014-
Life Medical Center & Research, IncMiami LakesFlorida33014-
Wellness Clinical ResearchMiami LakesFlorida33016-
Pharma Research International, Inc.NaplesFlorida34110-
Center for Interventional EndoscopyOrlandoFlorida32803-
Clintheory HealthcareOrlandoFlorida32818-
Gastroenterology Associates of Pensacola, PAPensacolaFlorida32503-
Florida Digestive SpecialistSt. PetersburgFlorida33709-
Florida Medical Clinic LLCZephyrhillsFlorida33542-7505-
Digestive Healthcare of GeorgiaAtlantaGeorgia30309-
Gastrointestinal Diseases ResearchColumbusGeorgia31904-
Atlanta Gastroenterology Specialists, PCSuwaneeGeorgia30024-
Grand Teton Research GroupIdaho FallsIdaho83404-
NorthShore University HealthSystemEvanstonIllinois60201-
Indiana University School of MedicineIndianapolisIndiana46202-
Iowa Digestive Disease CenterCliveIowa50325-
Cotton-O'Neil Clinical Research Center, Digestive HealthTopekaKansas66606-
Texas Digestive Disease ConsultantsBaton RougeLouisiana70809-
Clinical Trials of SWLA, LLCLake CharlesLouisiana70601-
Delta Research Partners LLCMonroeLouisiana71201-
Nola Research Works, LLCNew OrleansLouisiana70125-
Tulane Univ School of MedNew OrleansLouisiana70112 2715-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Henry Ford Health SystemNoviMichigan48377-
Gastroenterology Associates of Western Michigan, P.L.C.WyomingMichigan49519-
Huron Gastroenterology AssociatesYpsilantiMichigan48197-
MNGI Digestive Health - Plymouth Endoscopy Center & ClinicPlymouthMinnesota55446-
Care Access Research LLCJacksonMississippi39206-
Digestive Health SpecialistsTupeloMississippi38801-
Washington University Medical SchoolSt LouisMissouri63110-
Capital Health Medical Center HopewellPenningtonNew Jersey08534-
Northwell HealthGreat NeckNew York11021-
NYU Langone Long Island Clinical Research AssociatesLake SuccessNew York11042-
Weill Cornell Medical CollegeNew YorkNew York10021-
University of North CarolinaChapel HillNorth Carolina27599-
Carolina Digestive Diseases and Endoscopy CenterGreenvilleNorth Carolina27834-
Wake Forest University School of MedicineWinston-SalemNorth Carolina27157-1045-
Trinity Health Center Medical ArtsMinotNorth Dakota58701-
META Medical Research Institute, LLCDaytonOhio45432-
Paramount Medical ResearchMiddleburg HeightsOhio44130-
Care Access Research - YoungstownPolandOhio44514-
Great Lakes Medical Research, LLCWestlakeOhio44145-
Central Sooner ResearchNormanOklahoma73071-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Digestive Disease AssociatesWyomissingPennsylvania19610-
Ocean State Clinical Research PartnersLincolnRhode Island02865-
Invocare Clinical Research CenterMauldinSouth Carolina29662-
Invocare Clinical Research CenterWest ColumbiaSouth Carolina29169-
Midwest Medical CareSioux FallsSouth Dakota57108-
Gastro OneGermantownTennessee38138-
Galen Medical GroupHixsonTennessee37343-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas Medical Branch at GalvestonGalvestonTexas77555-
Digestive Health Associates of TexasGarlandTexas75044-
Biopharma Informatic, Inc.HoustonTexas77043-
Houston Methodist Research InsHoustonTexas77030-
Bandera Family Health CareSan AntonioTexas78249-
Gastroenterology Research of San AntonioSan AntonioTexas78229-
Southern Star Research Institute, LLCSan AntonioTexas78229-
Texas Digestive Disease ConsultantsSouthlakeTexas76092-
GI and Liver Research, LLCWebsterTexas77598-
Care Access Research LLC - Salt Lake CityOgdenUtah84403-
Care Access Research LLC - Salt Lake CitySalt Lake CityUtah84124-
Emeritas Research GroupLeesburgVirginia20176-
Blue Ridge Medical ResearchLynchburgVirginia24502-
The Gastroenterology Group, P.C.RestonVirginia20191-
Carilion ClinicRoanokeVirginia24016-
University of Washington Medical CenterSeattleWashington98195-6424-
Allegiance Research Specialists, LLCMilwaukeeWisconsin53226-
Wisconsin Center for Advanced ResearchMilwaukeeWisconsin53215-

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By research site
Digestive Health Specialists of the Southeast· Dothan, ALDcr-Pi, Pc· Litchfield Park, AZMaricopa Integrated Health System· Phoenix, AZPhysicians Research Group· Tempe, AZYuma Gastro LLC· Yuma, AZValley Gastroenterology· Arcadia, CA

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