An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT03759288
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Brazikumab low dose — DRUG
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
  • Brazikumab high dose — DRUG
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
  • Humira® — DRUG
    Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
  • Placebo — DRUG
    Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48

Study Details

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Key Dates

Start date
Dec 7, 2018
Status verified
May 2026
Primary completion
Oct 18, 2023
Completion
Oct 18, 2023

Study Design

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

Arms

  • Experimental: (Stage 1) Brazikumab high dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
  • Experimental: (Stage 1) Brazikumab low dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
  • Placebo Comparator: (Stage 1) Placebo
    Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
  • Experimental: (Stage 2) Brazikumab high dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
  • Experimental: (Stage 2) Brazikumab low dose
    Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48
  • Active Comparator: (Stage 2) Humira®
    Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50

Primary Outcome Measure

CDAI Remission [ Time Frame: at Week 12 ]

Locations (38)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85037-
Research SiteLittle RockArkansas72212-
Research SiteLancasterCalifornia93534-
Research SiteLincolnCalifornia95648-
Research SitePowayCalifornia92064-
Research SiteSan DiegoCalifornia92103-
Research SiteColorado SpringsColorado80907-
Research SiteBoca RatonFlorida33487-
Research SiteClearwaterFlorida33756-
Research SiteKissimmeeFlorida34741-
Research SiteLakelandFlorida33813-
Research SiteMiamiFlorida33157-
Research SiteMiamiFlorida33165-
Research SiteMiamiFlorida33189-
Research SiteMiami LakesFlorida33016-
Research SiteNaplesFlorida34102-
Research SiteSt. PetersburgFlorida33710-
Research SiteTampaFlorida33626-
Research SiteAtlantaGeorgia30328-
Research SiteAtlantaGeorgia30342-
Research SiteDecaturGeorgia30033-
Research SiteOak LawnIllinois60453-
Research SiteBrownsburgIndiana46112-
Research SiteChesterfieldMichigan48047-
Research SiteLas VegasNevada89123-
Research SiteAlbuquerqueNew Mexico87108-
Research SiteMorehead CityNorth Carolina28557-
Research SiteBeachwoodOhio44122-
Research SiteOklahoma CityOklahoma73102-
Research SiteUniontownPennsylvania15401-
Research SiteCarrolltonTexas75007-
Research SiteHoustonTexas77017-
Research SiteHoustonTexas77058-
Research SiteMcAllenTexas78503-
Research SitePflugervilleTexas78660-
Research SiteStaffordTexas77477-
Research SiteNorth ChesterfieldVirginia23236-
Research SiteSpokaneWashington99204-

Related coverage on Hipa.ai

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By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
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