A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05197049
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab Dose 1 — DRUG
    Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.
  • Guselkumab Dose 2 — DRUG
    Guselkumab (Dose 2) will be administered by SC injection.
  • Guselkumab Dose 3 — DRUG
    Guselkumab (Dose 3) will be administered by SC injection.
  • Placebo — DRUG
    Placebo will be administered by SC injection.

Study Details

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Key Dates

Start date
Jan 19, 2022
Status verified
Jun 2026
Primary completion
Jul 4, 2023
Completion
Oct 30, 2028

Study Design

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

Arms

  • Experimental: Group 1: Guselkumab
    Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
  • Experimental: Group 2: Guselkumab
    Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
  • Placebo Comparator: Group 3: Placebo
    Participants will receive placebo injection subcutaneously.

Primary Outcome Measure

Percentage of Participants Who Achieved Clinical Remission at Week 12 [ Time Frame: At Week 12 ]

Locations (77)

FacilityCityStateZIPSite coordinators
Digestive Health Specialists of the SoutheastDothanAlabama36305-
Advanced Gastro P.CChandlerArizona85224-1636-
Reliance ResearchScottsdaleArizona85260-
Central Arkansas Veterans Healthcare SystemLittle RockArkansas72223-
Moore Clinical Trials, LLCLittle RockArkansas72205-6414-
Om Research LLCLancasterCalifornia93534-
Om Research LLC 1LancasterCalifornia93534-
United GastroenterologistsLos AlamitosCalifornia90720-
Paul Wallace MDLos AngelesCalifornia90048-
Clinnova ResearchOrangeCalifornia92868-
Digestive System HealthcarePasadenaCalifornia77505-3950-
Clinical Applications Laboratories, IncSan DiegoCalifornia92103-
Northshore Gastroenterology Research, LLCSan DiegoCalifornia92103-2120-
Santa Maria GastroenterologySanta MariaCalifornia93454-
Clinical Research of CaliforniaWalnut CreekCalifornia94598-
Amel Med LLC ResearchGrand JunctionColorado81505-1027-
Western Connecticut Health Network/Danbury HospitalDanburyConnecticut06810-
Gastroenterology Associates of SW FloridaClearwaterFlorida33762-5323-
Pioneer Research Solutions Inc.Coconut CreekFlorida33066-
Omega Research ConsultantsDeBaryFlorida32713-
Harmony Medical Research Institute, Inc.HialeahFlorida33016-
Central Florida Gastro ResearchKissimmeeFlorida34741-
Community Research Foundation, Inc.MiamiFlorida33155-
Gastroenterology Group Of NaplesNaplesFlorida34102-
Center for Digestive HealthOrlandoFlorida32803-1853-
Central Florida InternistsOrlandoFlorida32819-
Synergy Clinical ResearchSt. PetersburgFlorida33705-
Agile Clinical Research Trials, LLCAtlantaGeorgia30328-
Atlanta Gastroenterology Specialists, PCAtlantaGeorgia30224-
Atlanta Center For GastroenterologyDecaturGeorgia30033-
Gastroenterolgy Associates of Central GAMaconGeorgia31201-
Gastroenterology ConsultantsRoswellGeorgia30076-4943-
USF Asthma, Allergy, Immunology Clinical Research UnitBoiseIdaho83706-
Grand Teton Research Group, PLLCIdaho FallsIdaho83404-
Lemah Creek Clinical ResearchOakbrook TerraceIllinois60618-
University of Kansas Medical CenterKansas CityKansas66103-2937-
BVL Clinical ResearchLeawoodKansas66211-
Cotton O'Neil Digestive Health CenterTopekaKansas66606-
Tri-State Gastroenterology AssocCrestview HillsKentucky41017-
Tandem Clinical ResearchMarreroLouisiana70072-
Institute for Digestive Health and Liver DiseaseBaltimoreMaryland21202-2102-
Woodholme Gastroenterology AssociatesGlen BurnieMaryland21061-
Digestive Health Specialists PCChelmsfordMassachusetts01824-
FC Research, LLCSouth DartmouthMassachusetts02747-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Detroit Clinical Research CenterLivoniaMichigan48152-
University of Mississippi Medical CenterJacksonMississippi39216-
SUNY Downstate Medical CenterBrooklynNew York11203-
Smart Medical ResearchJackson HeightsNew York11372-
Crystal Run Healthcare LLPMiddletownNew York10941-
New York Gastroenterology AssociatesNew YorkNew York10075-
DiGiovanna Institute for Medical Education & ResearchNorth MassapequaNew York11758-
A1 Clinical NetworkQueensNew York11375-
Carolinas Medical CenterCharlotteNorth Carolina28207-
Onsite Clinical SolutionsCharlotteNorth Carolina28277-
Carolina ResearchGreenvilleNorth Carolina27834-
Gastroenterology Associates of the Piedmont, P.A.Winston-SalemNorth Carolina27103-
Central Ohio Endoscopy Center LLCColumbusOhio43214-
Dayton Gastroenterology, IncDaytonOhio45440-
Great Lakes GastroenterologyMentorOhio44060-
Central Sooner ResearchOklahoma CityOklahoma73120-
Integris Baptist OfficeOklahoma CityOklahoma73112-
Oklahoma University Health Science CenterOklahoma CityOklahoma73104-
Essential Medical ResearchTulsaOklahoma74137-7061-
The Oregon ClinicPortlandOregon97220-9428-
Frontier Clinical ResearchSmithfieldPennsylvania15478-
Gastroenterology Associates P.A.GreenvilleSouth Carolina29615-
Carolina Health SpecialistsMyrtle BeachSouth Carolina29572-
West Texas Clinical ResearchLubbockTexas79424-
Victoria GastroenterologyRichmondTexas77407-
Gastroenterology Clinic Of San Antonio P ASan AntonioTexas78229-
Wellness Clinical ResearchSan AntonioTexas78232-
Texas Digestive Disease ConsultantsSouthlakeTexas76092-
Digestive Health Specialists of TylerTylerTexas75701-
Care Access Research- Salt Lake CitySalt Lake CityUtah84124-
Burke Internal Medicine and ResearchBurkeVirginia22015-
Gastroenterology Associates of TidewaterChesapeakeVirginia23320-

Related coverage on Hipa.ai

Find similar trials in Dothan, AL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists of the Southeast· Dothan, ALAdvanced Gastro P.C· Chandler, AZReliance Research· Scottsdale, AZCentral Arkansas Veterans Healthcare System· Little Rock, ARMoore Clinical Trials, LLC· Little Rock, AROm Research LLC· Lancaster, CA

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