A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study ID
NCT05013905
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tulisokibart — BIOLOGICAL
    Tulisokibart administered by IV infusion as directed by the protocol
  • Companion Diagnostic (CDx) — DIAGNOSTIC_TEST
    PRA023 CDx Genotyping Assay

Study Details

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.

Key Dates

Start date
Jul 28, 2021
Status verified
Mar 2026
Primary completion
Sep 23, 2022
Completion
May 27, 2025

Study Design

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

Arms

  • Experimental: Induction Tulisokibart
    During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1 of Week 0, and 500 mg on Day 1 of Weeks 2, 6, and 10.
  • Experimental: OLE Tulisokibart 100 mg
    After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w).
  • Experimental: OLE Tulisokibart 250 mg
    After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.

Primary Outcome Measure

Adverse Events [ Time Frame: Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Prometheus Biosciences Selected SiteLos AngelesCalifornia90045-
Prometheus Biosciences Selected SiteLos AngelesCalifornia90048-
Prometheus Biosciences Selected SiteLibertyKansas64098-
Prometheus Biosciences Selected SiteChesterfieldMichigan48047-
Prometheus Biosciences Selected SiteYpsilantiMichigan48197-
Prometheus Biosciences Selected SiteSt LouisMissouri63141-
Prometheus Biosciences Selected SiteLebanonNew Hampshire03756-
Prometheus Biosciences Selected SiteNew YorkNew York10065-
Prometheus Biosciences Selected SiteGarlandTexas75044-
Prometheus Biosciences Selected SiteLubbockTexas79410-
Prometheus Biosciences Selected SiteLubbockTexas79424-
Prometheus Biosciences Selected SiteSan AntonioTexas78229-
Prometheus Biosciences Selected SiteSouthlakeTexas78229-
Prometheus Biosciences Selected SiteTylerTexas75702-
Prometheus Biosciences Selected SiteBellevueWashington98004-
Prometheus Biosciences Selected SiteTacomaWashington98405-

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Prometheus Biosciences Selected Site· Los Angeles, CAPrometheus Biosciences Selected Site· Liberty, KSPrometheus Biosciences Selected Site· Chesterfield, MIPrometheus Biosciences Selected Site· Ypsilanti, MIPrometheus Biosciences Selected Site· St Louis, MOPrometheus Biosciences Selected Site· Lebanon, NH

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