A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03104413
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

Key Dates

Start date
Dec 18, 2017
Status verified
Aug 2021
Primary completion
Nov 30, 2020
Completion
May 19, 2021

Study Design

Enrollment
618 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Risankizumab Dose 1 (Induction Period 1)
    Participants randomized to receive risankizumab dose 1 in Induction Period 1.
  • Experimental: Risankizumab Dose 2 (Induction Period 1)
    Participants randomized to receive risankizumab dose 2 in Induction Period 1.
  • Placebo Comparator: Placebo (Induction Period 1)
    Participants randomized to receive placebo for risankizumab in Induction Period 1.
  • Experimental: Risankizumab Dose 1 (Induction Period 2)
    Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
  • Experimental: Risankizumab Dose 2 (Induction Period 2)
    Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
  • Experimental: Risankizumab Dose 3 (Induction period 2)
    Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.

Primary Outcome Measure

US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 12 ]

Locations (114)

FacilityCityStateZIPSite coordinators
Phoenix VA Health Care System /ID# 162261PhoenixArizona85012-
HonorHealth Research Institute - Shea /ID# 165825ScottsdaleArizona85258-
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882TempeArizona85284-2604-
University of Arizona /ID# 158305TucsonArizona85724-
Duplicate_Atria Clinical Research /ID# 164504Little RockArkansas72209-7040-
Southern California Res. Ctr. /ID# 211989CoronadoCalifornia92118-1408-
Newport Huntington Medica /ID# 213034Huntington BeachCalifornia92648-5994-
UC San Diego Health Systems /ID# 155576La JollaCalifornia92093-
United Medical Doctors /ID# 207887Los AlamitosCalifornia90720-3309-
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655Los AngelesCalifornia90067-2001-
TLC Clinical Research Inc /ID# 212501Los AngelesCalifornia90048-
United Medical Doctors - Murrieta /ID# 158278MurrietaCalifornia92563-
Peak Gastroenterology Associates, PC /ID# 165832Colorado SpringsColorado80907-
Rocky Mountain Pediatric Gastroenterology /ID# 207171Lone TreeColorado80124-6798-
Western Connecticut Medical Group /ID# 165874DanburyConnecticut06810-6000-
Seffner Premier Health Care, PA /ID# 162259BrandonFlorida33510-
Clinical Research of West Florida, Inc /ID# 205864ClearwaterFlorida33765-
Clinical Research of West Florida, Inc /ID# 208127ClearwaterFlorida33765-
South Lake Pain Institute, Inc /ID# 162798ClermontFlorida34711-
Omega Research Maitland, LLC /ID# 171080DeBaryFlorida32713-2260-
Universal Axon Clinical Research /ID# 165426DoralFlorida33166-
SIH Research Mumtaz, Inc /ID# 163081KissimmeeFlorida34741-4161-
Alliance Medical Research /ID# 163834Lighthouse PTFlorida33064-
Cfagi Llc /Id# 202482MaitlandFlorida32751-6108-
Coral Research Clinic /ID# 158330MiamiFlorida33186-4643-
ITB Research /ID# 161278MiamiFlorida33176-
South Florida Research Ph I-IV, Inc. /ID# 161825MiamiFlorida33193-
University of Miami /ID# 155011MiamiFlorida33136-
Vista Health Research, LLC /ID# 212828MiamiFlorida33176-1032-
Gastroenterology Group Naples /ID# 165192NaplesFlorida34102-
Advanced Research Institute, Inc /ID# 161973New Port RicheyFlorida34653-
Endoscopic Research, Inc. /ID# 205903OrlandoFlorida32803-
IMIC Inc. Medical Research /ID# 154944Palmetto BayFlorida33157-
Clinical Research Trials of Florida, Inc. /ID# 201606TampaFlorida33607-
Atlanta Gastro Assoc /ID# 154755AtlantaGeorgia30342-
Gastroenterology Associates of Central Georgia, LLC /ID# 154865MaconGeorgia31201-
Northwestern University Division of GI/Hepatology /ID# 158250ChicagoIllinois60611-2927-
The University of Chicago Medical Center /ID# 157113ChicagoIllinois60637-1443-
NorthShore University HealthSystem /ID# 158254EvanstonIllinois60201-
Southwest Gastroenterology /ID# 164764Oak LawnIllinois60453-
Cotton-O'Neil Clinical Res Ctr /ID# 154753TopekaKansas66606-
University of Kentucky Chandler Medical Center /ID# 157109LexingtonKentucky40536-
University of Louisville /ID# 210523LouisvilleKentucky40202-
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970Baton RougeLouisiana70809-
Houma Digestive Health Special /ID# 158253HoumaLouisiana70360-
Delricht Research /ID# 206567New OrleansLouisiana70115-
Nola Research Works, LLC /ID# 161271New OrleansLouisiana70115-
Louisana Research Center, LLC /ID# 162239ShreveportLouisiana71105-6800-
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846Chevy ChaseMaryland20815-
Gastro Center of Maryland /ID# 164766ColumbiaMaryland21045-
Center for Digestive Health /ID# 154697TroyMichigan48098-6363-
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267WyomingMichigan49519-
Mayo Clinic - Rochester /ID# 163084RochesterMinnesota55905-0001-
University of Nebraska Medical Center /ID# 210056OmahaNebraska68198-2000-
Las Vegas Medical Research /ID# 160167Las VegasNevada89113-
Revival Research Institute, Inc /ID# 210986Las VegasNevada89128-3157-
NY Scientific /ID# 158272BrooklynNew York11235-
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446Burnt HillsNew York12027-
Intercity Advanced Gastroentertology Center /ID# 215204Fresh MeadowsNew York11366-
Duplicate_Long Island Clinical Research /ID# 154843Great NeckNew York11021-5343-
Digestive Disease Care /ID# 211776New Hyde ParkNew York11040-
North Shore University Hospital /ID# 168734New Hyde ParkNew York11040-
Columbia Univ Medical Center /ID# 167545New YorkNew York10032-3725-
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610New YorkNew York10029-
Lenox Hill Hospital /ID# 168466New YorkNew York10075-
NYU Langone Medical Center /ID# 160166New YorkNew York10016-6402-
Weill Cornell Medicine /ID# 165856New YorkNew York10022-
DiGiovanna Institute for Medical Education & Research /ID# 171130North MassapequaNew York11758-
Atrium Health Carolinas Medical Center /ID# 158364CharlotteNorth Carolina28203-
Vidant Multispecialty Clinic - Kinston /ID# 161109KinstonNorth Carolina28501-1589-
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891RaleighNorth Carolina27612-
Plains Clinical Research Center, LLC /ID# 169712FargoNorth Dakota58104-5925-
Tri-State Endoscopy /ID# 154939CincinnatiOhio45219-
Cleveland Clinic Main Campus /ID# 209225ClevelandOhio44195-
Optimed Research, Ltd. /ID# 167877ColumbusOhio43235-
The Ohio State University /ID# 164706ColumbusOhio43210-
Hometown Urgent Care and Resea /ID# 170447DaytonOhio45424-
Great Lakes Medical Research, LLC /ID# 201774MentorOhio44060-6211-
Digestive Disease Specialists /ID# 170772Oklahoma CityOklahoma73112-
Hightower Clinical /ID# 211992Oklahoma CityOklahoma73102-
Adult Gastroenterology Associates - Gen 1 Research /ID# 208857TulsaOklahoma74136-7823-
Northwest Gastroenterology Clinic /ID# 158255PortlandOregon97210-
PennState Milton S.Hershey Med /ID# 154894HersheyPennsylvania17033-
Children's Hospital of Pittsburgh of UPMC /ID# 212543PittsburghPennsylvania15224-1334-
Digestive Disease Associates, LTD /ID# 208296WyomissingPennsylvania19610-2002-
Medical University of South Carolina /ID# 212859CharlestonSouth Carolina29425-
Gastroenterology Associates, P.A. of Greenville /ID# 154919GreenvilleSouth Carolina29615-3593-
Rapid City Medical Center - GI Research /ID# 163835Rapid CitySouth Dakota57701-
Gastro One /ID# 154757GermantownTennessee38138-
East Tennessee Research Institute /ID# 168735Johnson CityTennessee37604-
Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179MemphisTennessee38119-
Vanderbilt University Medical Center /ID# 157110NashvilleTennessee37232-0011-
TX Clinical Research Institute /ID# 159396ArlingtonTexas76012-
Inquest Clinical Research /ID# 165696BaytownTexas77521-2415-
Texas Digestive Disease Consultants /ID# 209781Cedar ParkTexas78613-5028-
Texas Digestive Disease Consultants /ID# 209945Cedar ParkTexas78613-5028-
DHAT Research Institute /ID# 158199GarlandTexas75044-2208-
Baylor College of Medicine - Baylor Medical Center /ID# 158194HoustonTexas77030-3411-
Centex Studies, Inc. - Houston /ID# 201218HoustonTexas77058-
CliniCore International, LLC /ID# 158191HoustonTexas77027-6812-
Precision Research Institute, LLC /ID# 201072HoustonTexas77036-
Vilo Research Group Inc /ID# 207654HoustonTexas77017-2337-
Clinical Associates in Research Therapeutics of America, LLC /ID# 161307San AntonioTexas78212-
Southern Star Research Institute, LLC /ID# 168772San AntonioTexas78229-5390-
Baylor Scott & White Medical Center- Temple /ID# 204129TempleTexas76508-0001-
Tyler Research Institute, LLC /ID# 166795TylerTexas75701-4464-
Gastro Health & Nutrition - Victoria /ID# 164284VictoriaTexas77904-
HP Clinical Research /ID# 162992BountifulUtah84010-
Advanced Research Institute /ID# 154922OgdenUtah84403-
Velocity Clinical Research - Salt Lake City /ID# 161775West JordanUtah84088-
Hunter Holmes McGuire VA Medical Center /ID# 159977RichmondVirginia23249-
Washington Gastroenterology Associates /ID# 162101BellevueWashington98004-
Virginia Mason - Seattle Orthapedics /ID# 155577SeattleWashington98101-
WVU Medicine /ID# 167942MorgantownWest Virginia26506-1200-

Find similar trials in Phoenix, AZ

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Phoenix VA Health Care System· Phoenix, AZHonorHealth Research Institute - Shea· Scottsdale, AZDigestive Disease Consultants, A Division of Arizona Digestive Health, P.C· Tempe, AZUniversity of Arizona· Tucson, AZDuplicate_Atria Clinical Research· Little Rock, ARSouthern California Res. Ctr.· Coronado, CA

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