Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06651281 | Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) | PHASE3 | RECRUITING | 1,380 | — | — | Nov 25, 2024 | Dec 17, 2037 | May 19, 2026 | 37 | United States, Czechia +5 |
| NCT05013905 | 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) | PHASE2 | COMPLETED | 55 | — | — | Jul 28, 2021 | May 27, 2025 | Apr 21, 2026 | 37 | United States, Australia +6 |
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Number of participants who experienced treatment-emergent adverse events (AEs)
Number of participants who experienced serious adverse events (SAEs)
Number of participants who experienced AEs leading to discontinuation
Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \[SES-CD\] ≥ 50% from Baseline)
| Arm | Type | Description |
|---|---|---|
| Group 1: Low Dose Unblinded | EXPERIMENTAL | Participants receive a low dose subcutaneous (SC) tulisokibart regimen. |
| Group 2: High Dose Unblinded | EXPERIMENTAL | Participants receive a high dose SC tulisokibart regimen. |
| Group 3: High Dose Blinded | EXPERIMENTAL | Participants receive a blinded high dose SC tulisokibart regimen. |
| Group 4: Low Dose Blinded | EXPERIMENTAL | Participants receive a blinded low dose SC tulisokibart regimen. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Tulisokibart | DRUG | Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously |
| Placebo to tulisokibart | DRUG | Placebo matching SC tulisokibart |
| Companion Diagnostic (CDx) | DIAGNOSTIC_TEST | PRA023 CDx Genotyping Assay |
Inclusion Criteria: * Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC * The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study * A part...