Phase 2
Completed N=178
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
Source: ClinicalTrials.gov NCT04996797 ↗Enrolled (actual)
178
Serious AEs
4.5%
Results posted
Jun 2024
Primary outcomePrimary: Percentage of Participants in Cohort 1 Achieving Clinical Remission — 26.5; 1.5 Percentage of participants — p=<.0001
Summary
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Cohort 1 Achieving Clinical Remission |
26.5; 1.5 | <.0001 sig |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event (AE) |
45.6; 43.2 | — |
| PRIMARY Percentage of Participants Who Discontinued Due to an AE |
1.1; 3.4 | — |
| PRIMARY Percentage of Participants Who Had One or More Serious Adverse Events |
1.1; 8.0 | — |
| SECONDARY Percentage of Participants in Cohort 1 With Endoscopic Improvement |
36.8; 6.0 | <0.0001 sig |
| SECONDARY Percentage of Participants in Cohort 1 Achieving Clinical Response |
66.2; 22.4 | <.0001 sig |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Remission |
31.6; 10.8 | 0.0224 sig |
| SECONDARY Percentage of Participants in Cohort 1 With Symptomatic Remission |
19.1; 6.0 | 0.0223 sig |
| SECONDARY Percentage of Participants in Cohort 1 With Histologic Improvement |
46.2; 17.5 | 0.0009 sig |
| SECONDARY Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Improvement |
30.8; 3.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Endoscopic Improvement |
36.8; 18.9 | — |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Clinical Response |
55.3; 32.4 | — |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Symptomatic Remission |
21.1; 10.8 | — |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic Improvement |
55.6; 26.7 | — |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Improvement |
38.9; 16.7 | — |
| SECONDARY Percentage of Participants in Cohort 1 With Histologic-endoscopic Mucosal Healing |
30.8; 3.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Were CDx+ (Cohorts 1 + 2) With Histologic-endoscopic Mucosal Healing |
38.9; 16.7 | — |
| SECONDARY Percentage of Participants in Cohort 1 With an Inflammatory Bowel Disease Questionnaire (IBDQ) Response |
82.4; 49.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Are CDx+ (Cohorts 1 + 2) Who Had an IBDQ Response |
76.3; 56.8 | — |
Eligibility Criteria
Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
- Confirmed diagnosis of ulcerative colitis (UC)
- Has moderately to severely active UC as defined by 3-component Modified Mayo score
- 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 (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
- Has diagnosis of Crohn's disease or indeterminate colitis
- Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
- Has current or impending need for colostomy or ileostomy
- Has had surgical bowel resection within 3 months before screening
- Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
Data sourced from ClinicalTrials.gov (NCT04996797). 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.