--- title: "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)" nct_id: NCT05013905 overall_status: COMPLETED phase: PHASE2 sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) study_type: INTERVENTIONAL primary_condition: Crohn Disease countries: United States, Australia, Belgium, Canada, Czechia, France, Georgia, Poland canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05013905.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05013905" ct_last_update_post_date: 2026-04-21 last_seen_at: "2026-05-12T07:07:04.785Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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) **Official Title:** A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease **NCT ID:** [NCT05013905](https://clinicaltrials.gov/study/NCT05013905) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 55 - **Lead Sponsor:** Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) - **Conditions:** Crohn Disease - **Start Date:** 2021-07-28 - **Completion Date:** 2025-05-27 - **CT.gov Last Update:** 2026-04-21 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Confirmed diagnosis of Crohn's disease (CD) * Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy * Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23 * Able to provide written informed consent and understand and comply with the requirements of the study Exclusion Criteria: * Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug * Diagnosis of ulcerative colitis (UC) or indeterminate colitis * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement * Suspected or diagnosed intra-abdominal or perianal abscess at screening * Current stoma or need for colostomy or ileostomy * Previous small bowel resection with a combined resected length of \>100 cm or previous colonic resection of \> 2 segments * Surgical bowel resection within 3 months before screening * Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed * Participants in the opinion of the investigator are at an unacceptable risk for participation in the study * Participants who meet the protocol criteria for important laboratory exclusion criteria ``` ## Arms - **Induction Tulisokibart** (EXPERIMENTAL) — 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. - **OLE Tulisokibart 100 mg** (EXPERIMENTAL) — 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). - **OLE Tulisokibart 250 mg** (EXPERIMENTAL) — 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. ## Interventions - **Tulisokibart** (BIOLOGICAL) — Tulisokibart administered by IV infusion as directed by the protocol - **Companion Diagnostic (CDx)** (DIAGNOSTIC_TEST) — PRA023 CDx Genotyping Assay ## Primary Outcomes - **Adverse Events** _(time frame: Week 12)_ — Number of participants who experienced treatment-emergent adverse events (AEs) - **Serious Adverse Events** _(time frame: Week 12)_ — Number of participants who experienced serious adverse events (SAEs) - **Adverse Events Leading to Discontinuation** _(time frame: Week 12)_ — Number of participants who experienced AEs leading to discontinuation - **Endoscopic Improvement** _(time frame: Week 12)_ — Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] ≥ 50% from Baseline) ## Secondary Outcomes - **Clinical Remission** _(time frame: Week 12)_ - **Endoscopic and Clinical Improvement** _(time frame: Week 12)_ - **Number of Participants Achieving a Composite Response** _(time frame: Week 12)_ - **Normalization of C-reactive Protein** _(time frame: Week 12)_ - **Normalization of Fecal Calprotectin** _(time frame: Week 12)_ - **Clinical Response** _(time frame: Week 12)_ - **Two Component Patient-reported Outcome (PRO-2) Remission** _(time frame: Week 12)_ - **Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)** _(time frame: Baseline and Week 12)_ - **Serum Concentration of PRA023 (MK-7240)** _(time frame: Week 12)_ - **Number of Participants Positive for Anti-drug Antibody (ADA)** _(time frame: Up to approximately 12 weeks)_ - **Number of Participants With Positive Neutralizing Anti-Bodies (NAB)** _(time frame: Up to approximately 12 weeks)_ ## Locations (37) - Prometheus Biosciences Selected Site, Los Angeles, California, United States - Prometheus Biosciences Selected Site, Los Angeles, California, United States - Prometheus Biosciences Selected Site, Liberty, Kansas, United States - Prometheus Biosciences Selected Site, Chesterfield, Michigan, United States - Prometheus Biosciences Selected Site, Ypsilanti, Michigan, United States - Prometheus Biosciences Selected Site, St Louis, Missouri, United States - Prometheus Biosciences Selected Site, Lebanon, New Hampshire, United States - Prometheus Biosciences Selected Site, New York, New York, United States - Prometheus Biosciences Selected Site, Garland, Texas, United States - Prometheus Biosciences Selected Site, Lubbock, Texas, United States - Prometheus Biosciences Selected Site, Lubbock, Texas, United States - Prometheus Biosciences Selected Site, San Antonio, Texas, United States - Prometheus Biosciences Selected Site, Southlake, Texas, United States - Prometheus Biosciences Selected Site, Tyler, Texas, United States - Prometheus Biosciences Selected Site, Bellevue, Washington, United States - Prometheus Biosciences Selected Site, Tacoma, Washington, United States - Prometheus Biosciences Selected Site, Bankstown, New South Wales, Australia - Prometheus Biosciences Selected Site, Woolloongabba, Queensland, Australia - Prometheus Biosciences Selected Site, Adelaide, South Australia, Australia - Prometheus Biosciences Selected Site, Leuven, Belgium - Prometheus Biosciences Selected Site, Liège, Belgium - Prometheus Biosciences Selected Site, London, Ontario, Canada - Prometheus Biosciences Selected Site, Brno, Czechia - Prometheus Biosciences Selected Site, Slaný, Czechia - Prometheus Biosciences Selected Site, Clichy, France - Prometheus Biosciences Selected Site, Nice, France - Prometheus Biosciences Selected Site, Saint-Priest-en-Jarez, France - Prometheus Biosciences Selected Site, Vandœuvre-lès-Nancy, France - Prometheus Biosciences Selected Site, Tbilisi, Georgia - Prometheus Biosciences Selected Center, Krakow, Poland - Prometheus Biosciences Selected Site, Rzeszów, Poland - Prometheus Biosciences Selected Site, Sopot, Poland - Prometheus Biosciences Selected Site, Torun, Poland - Prometheus Biosciences Selected Center, Warsaw, Poland - Prometheus Biosciences Selected Site, Warsaw, Poland - Prometheus Biosciences Selected Center, Warsaw, Poland - Prometheus Biosciences Selected Site, Wroclaw, Poland ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|los angeles|california|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|liberty|kansas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|chesterfield|michigan|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|ypsilanti|michigan|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|lebanon|new hampshire|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|new york|new york|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|garland|texas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|lubbock|texas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|san antonio|texas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|southlake|texas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|tyler|texas|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|bellevue|washington|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|tacoma|washington|united states` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|bankstown|new south wales|australia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|woolloongabba|queensland|australia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|adelaide|south australia|australia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|leuven||belgium` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|liège||belgium` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|london|ontario|canada` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|brno||czechia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|slaný||czechia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|clichy||france` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|nice||france` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|saint-priest-en-jarez||france` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|vandœuvre-lès-nancy||france` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|tbilisi||georgia` — added _(2026-05-12)_ - `locations.prometheus biosciences selected center|krakow||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|rzeszów||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|sopot||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|torun||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected center|warsaw||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|warsaw||poland` — added _(2026-05-12)_ - `locations.prometheus biosciences selected site|wroclaw||poland` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05013905.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05013905* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*