Phase 2
Completed N=55
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)
Crohn Disease
Source: ClinicalTrials.gov NCT05013905 ↗
Enrolled (actual)
55
Serious AEs
14.5%
Results posted
Nov 2023
Primary outcomePrimary: Adverse Events — 43 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
43 | — |
| PRIMARY Serious Adverse Events |
8 | — |
| PRIMARY Adverse Events Leading to Discontinuation |
2 | — |
| PRIMARY Endoscopic Improvement |
13 | — |
| SECONDARY Clinical Remission |
27 | — |
| SECONDARY Endoscopic and Clinical Improvement |
9 | — |
| SECONDARY Number of Participants Achieving a Composite Response |
17 | — |
| SECONDARY Normalization of C-reactive Protein |
5 | — |
| SECONDARY Normalization of Fecal Calprotectin |
6 | — |
| SECONDARY Clinical Response |
37 | — |
| SECONDARY Two Component Patient-reported Outcome (PRO-2) Remission |
27 | — |
| SECONDARY Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD) |
-2.6 | — |
| SECONDARY Serum Concentration of PRA023 (MK-7240) |
88199.1 | — |
| SECONDARY Number of Participants Positive for Anti-drug Antibody (ADA) |
8 | — |
| SECONDARY Number of Participants With Positive Neutralizing Anti-Bodies (NAB) |
8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05013905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.