A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03105128
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

Key Dates

Start date
May 10, 2017
Status verified
Jun 2022
Primary completion
Nov 9, 2020
Completion
Apr 14, 2021

Study Design

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

Arms

  • Experimental: Risankizumab Dose 1 (Period 1)
    Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
  • Experimental: Risankizumab Dose 2 (Period 1)
    Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
  • Placebo Comparator: Placebo (Period 1)
    Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
  • Experimental: Risankizumab Dose 1 (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 (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 (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 (117)

FacilityCityStateZIPSite coordinators
Phoenix VA Health Care System /ID# 162267PhoenixArizona85012-
HonorHealth Research Institute - Shea /ID# 161783ScottsdaleArizona85258-
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211883TempeArizona85284-2604-
University of Arizona /ID# 158469TucsonArizona85724-
Atria Clinical Research /ID# 164740Little RockArkansas72209-7040-
Newport Huntington Medica /ID# 213033Huntington BeachCalifornia92648-5994-
United Medical Doctors /ID# 207040Los AlamitosCalifornia90720-3309-
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162656Los AngelesCalifornia90067-2001-
TLC Clinical Research Inc /ID# 212503Los AngelesCalifornia90048-
United Medical Doctors - Murrieta /ID# 158424MurrietaCalifornia92563-
Southern CA Research Ctr., Inc /ID# 167875RiversideCalifornia92501-
University of California, San Francisco /ID# 157143San FranciscoCalifornia94158-
Cedars-Sinai Medical Center-West Hollywood /ID# 163842West HollywoodCalifornia90048-
Peak Gastroenterology Associates, PC /ID# 165834Colorado SpringsColorado80907-
Rocky Mountain Pediatric Gastroenterology /ID# 207169Lone TreeColorado80124-6798-
Western Connecticut Medical Group /ID# 165849DanburyConnecticut06810-6000-
Seffner Premier Health Care, PA /ID# 162265BrandonFlorida33510-
Clinical Research of West Florida, Inc /ID# 204859ClearwaterFlorida33765-
Clinical Research of West Florida, Inc /ID# 207450ClearwaterFlorida33765-
South Lake Pain Institute, Inc /ID# 162825ClermontFlorida34711-
Universal Axon Clinical Research /ID# 165432DoralFlorida33166-
Nature Coast Clinical Research - Inverness /ID# 159414InvernessFlorida34452-4717-
SIH Research Mumtaz, Inc /ID# 163082KissimmeeFlorida34741-4161-
Alliance Medical Research /ID# 163840Lighthouse PTFlorida33064-
Cfagi Llc /Id# 201571MaitlandFlorida32751-6108-
Coral Research Clinic /ID# 158549MiamiFlorida33186-4643-
ITB Research /ID# 161334MiamiFlorida33176-
South Florida Research Ph I-IV, Inc. /ID# 161836MiamiFlorida33193-
Vista Health Research, LLC /ID# 212664MiamiFlorida33176-1032-
Gastroenterology Group Naples /ID# 165206NaplesFlorida34102-
Advanced Research Institute, Inc /ID# 161959New Port RicheyFlorida34653-
Endoscopic Research, Inc. /ID# 205901OrlandoFlorida32803-
Omega Research Maitland, LLC /ID# 171081OrlandoFlorida32810-2907-
IMIC Inc. Medical Research /ID# 154943Palmetto BayFlorida33157-
Clinical Research Trials of Florida, Inc. /ID# 201014TampaFlorida33607-
Gastroenterology Associates of Central Georgia, LLC /ID# 154857MaconGeorgia31201-
Northwestern University Division of GI/Hepatology /ID# 158283ChicagoIllinois60611-2927-
The University of Chicago Medical Center /ID# 157141ChicagoIllinois60637-1443-
NorthShore University HealthSystem /ID# 158287EvanstonIllinois60201-
Southwest Gastroenterology /ID# 165002Oak LawnIllinois60453-
Cotton-O'Neil Clinical Res Ctr /ID# 154738TopekaKansas66606-
University of Kentucky Chandler Medical Center /ID# 157137LexingtonKentucky40536-
University of Louisville /ID# 210521LouisvilleKentucky40202-
Gastroenterology Associates LLC - Jefferson Hwy /ID# 161956Baton RougeLouisiana70809-
Houma Digestive Health Special /ID# 158286HoumaLouisiana70360-
Delricht Research /ID# 206542New OrleansLouisiana70115-
Nola Research Works, LLC /ID# 161330New OrleansLouisiana70115-
Louisana Research Center, LLC /ID# 162236ShreveportLouisiana71105-6800-
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154839Chevy ChaseMaryland20815-
Gastro Center of Maryland /ID# 165004ColumbiaMaryland21045-
University of Michigan Health Systems /ID# 157144Ann ArborMichigan48109-
Center for Digestive Health /ID# 154690TroyMichigan48098-6363-
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161328WyomingMichigan49519-
Mayo Clinic - Rochester /ID# 163085RochesterMinnesota55905-0001-
Southern Therapy and Advanced Research (STAR) LLC /ID# 162388JacksonMississippi39216-
St. Louis University /ID# 161902St LouisMissouri63104-
University of Nebraska Medical Center /ID# 210057OmahaNebraska68198-2000-
Las Vegas Medical Research /ID# 160172Las VegasNevada89113-
Revival Research Institute, Inc /ID# 210984Las VegasNevada89128-3157-
NY Scientific /ID# 158418BrooklynNew York11235-
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 212036Burnt HillsNew York12027-
Intercity Advanced Gastroentertology Center /ID# 213399Fresh MeadowsNew York11366-
Duplicate_Long Island Clinical Research /ID# 154836Great NeckNew York11021-5343-
Digestive Disease Care /ID# 209619New Hyde ParkNew York11040-
North Shore University Hospital /ID# 168736New Hyde ParkNew York11040-
Columbia Univ Medical Center /ID# 161911New YorkNew York10032-3725-
Lenox Hill Hospital /ID# 168465New YorkNew York10075-
NYU Langone Medical Center /ID# 160171New YorkNew York10016-6402-
DiGiovanna Institute for Medical Education & Research /ID# 171118North MassapequaNew York11758-
Univ NC Chapel Hill /ID# 154840Chapel HillNorth Carolina27514-4220-
Atrium Health Carolinas Medical Center /ID# 158481CharlotteNorth Carolina28203-
Clinical Trials America /ID# 158484HickoryNorth Carolina28601-
Vidant Multispecialty Clinic - Kinston /ID# 161111KinstonNorth Carolina28501-1589-
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154880RaleighNorth Carolina27612-
Plains Clinical Research Center, LLC /ID# 169715FargoNorth Dakota58104-5925-
Tri-State Endoscopy /ID# 154933CincinnatiOhio45219-
Cleveland Clinic Main Campus /ID# 208171ClevelandOhio44195-
Optimed Research, Ltd. /ID# 167901ColumbusOhio43235-
The Ohio State University /ID# 164709ColumbusOhio43210-
Hometown Urgent Care and Resea /ID# 170453DaytonOhio45424-
Great Lakes Medical Research, LLC /ID# 201732MentorOhio44060-6211-
Digestive Disease Specialists /ID# 170774Oklahoma CityOklahoma73112-
Hightower Clinical /ID# 211938Oklahoma CityOklahoma73102-
Adult Gastroenterology Associates - Gen 1 Research /ID# 206125TulsaOklahoma74136-7823-
Northwest Gastroenterology Clinic /ID# 158288PortlandOregon97210-
PennState Milton S.Hershey Med /ID# 154883HersheyPennsylvania17033-
Children's Hospital of Pittsburgh of UPMC /ID# 210920PittsburghPennsylvania15224-1334-
Digestive Disease Associates, LTD /ID# 208847WyomissingPennsylvania19610-2002-
Medical University of South Carolina /ID# 212579CharlestonSouth Carolina29425-
Gastroenterology Associates, P.A. of Greenville /ID# 154911GreenvilleSouth Carolina29615-3593-
Rapid City Medical Center - GI Research /ID# 163841Rapid CitySouth Dakota57701-
Gastro One /ID# 154742GermantownTennessee38138-
East Tennessee Research Institute /ID# 168737Johnson CityTennessee37604-
Duplicate_Clinical Neuroscience Solutions /ID# 164181MemphisTennessee38119-4823-
Vanderbilt University Medical Center /ID# 157138NashvilleTennessee37232-0011-
TX Clinical Research Institute /ID# 159410ArlingtonTexas76012-
Inquest Clinical Research /ID# 165695BaytownTexas77521-2415-
Texas Digestive Disease Consultants /ID# 209596Cedar ParkTexas78613-5028-
Texas Digestive Disease Consultants /ID# 209785Cedar ParkTexas78613-5028-
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 201848DallasTexas75246-
DHAT Research Institute /ID# 158217GarlandTexas75044-2208-
Baylor College of Medicine - Baylor Medical Center /ID# 158212HoustonTexas77030-3411-
Centex Studies, Inc. - Houston /ID# 200720HoustonTexas77058-
CliniCore International, LLC /ID# 158209HoustonTexas77027-6812-
Precision Research Institute, LLC /ID# 200503HoustonTexas77036-
Vilo Research Group Inc /ID# 206130HoustonTexas77017-2337-
Clinical Associates in Research Therapeutics of America, LLC /ID# 161336San AntonioTexas78212-
Southern Star Research Institute, LLC /ID# 168770San AntonioTexas78229-5390-
Tyler Research Institute, LLC /ID# 166796TylerTexas75701-4464-
Gastro Health & Nutrition - Victoria /ID# 164296VictoriaTexas77904-
HP Clinical Research /ID# 162998BountifulUtah84010-
Advanced Research Institute /ID# 154914OgdenUtah84403-
Velocity Clinical Research - Salt Lake City /ID# 161781West JordanUtah84088-
McGuire DV AMC /ID# 159990RichmondVirginia23249-
Washington Gastroenterology Associates /ID# 162120BellevueWashington98004-
Virginia Mason - Seattle Orthapedics /ID# 155545SeattleWashington98101-
WVU Medicine /ID# 167940MorgantownWest 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, AZAtria Clinical Research· Little Rock, ARNewport Huntington Medica· Huntington Beach, CA

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