Tulisokibart for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Discontinued parent study, Allergies, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Tulisokibart for Crohn's Disease?

The research mentions that drugs like ustekinumab, which blocks certain proteins involved in inflammation, have been effective in treating Crohn's disease, especially for patients who did not respond to other treatments. This suggests that similar mechanisms in Tulisokibart could potentially be effective as well. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people who have moderate to severe Crohn's disease or ulcerative colitis and were part of earlier tulisokibart studies. They must be seeing benefits from the treatment, not pregnant or breastfeeding, and if they can get pregnant, they need to use birth control or practice abstinence.

Inclusion Criteria

I was part of a Phase 2 or 3 study for Crohn's disease or ulcerative colitis.

My doctor thinks I benefit from the ongoing treatment based on past study results.

I am not pregnant and have a recent negative pregnancy test.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low or high dose of tulisokibart, administered subcutaneously, in an unblinded or blinded manner

364 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Open-label extension

Participants may continue to receive tulisokibart to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Tulisokibart (Small Molecule)

Trial Overview The study is testing the long-term safety and effectiveness of a drug called tulisokibart in patients with Crohn's disease or ulcerative colitis. Participants are those who've taken it before in previous phases of research.

Participant Groups

Group I: Group 4: Low Dose Blinded Experimental Treatment 2 Interventions

Participants receive a blinded low dose SC tulisokibart regimen.

Group II: Group 3: High Dose Blinded Experimental Treatment 1 Intervention

Participants receive a blinded high dose SC tulisokibart regimen.

Group III: Group 2: High Dose Unblinded Experimental Treatment 1 Intervention

Participants receive a high dose SC tulisokibart regimen.

Group IV: Group 1: Low Dose Unblinded Experimental Treatment 1 Intervention

Participants receive a low dose subcutaneous (SC) tulisokibart regimen.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Southern Star Research Institute ( Site 0299) San Antonio, TX

GI Alliance - Southlake ( Site 0298) Southlake, TX

Tyler Research Institute ( Site 0294) Tyler, TX

GI Alliance - Lubbock ( Site 0288) Lubbock, TX

More Trial Locations

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. [2023] Risankizumab (RZB) and ustekinumab (UST), interleukin (IL)-23 and IL-12/23 inhibitors, respectively, are approved treatments for moderately to severely active Crohn's disease (CD); direct comparison between the two is ongoing. We indirectly compared efficacy of RZB versus UST using data from phase 3 trials (RZB: NCT03104413; NCT03105128; NCT03105102; UST: NCT01369329; NCT01369342; NCT01369355).

2. United States pubmed.ncbi.nlm.nih.gov

Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. [2022] The long-term efficacy and safety of upadacitinib was evaluated in an open-label extension (OLE) of a phase II, double-blind, randomized trial of patients with Crohn's disease.

3. Korea (South) pubmed.ncbi.nlm.nih.gov

[Emerging Therapies: What Are Promising in the Near Future?] [2018] The treatment of inflammatory bowel disease has evolved with the development of anti-TNF agents. In spite of long-term effectiveness, many patients do not respond or no longer responds to these drugs. Therefore, the development of new drugs that act on different inflammatory pathways has become necessary. Vedolizumab, a gut-specific biological agent, inhibits interaction α4β7 integrin with mucosal addressin cell adhesion molecule-1 without inhibiting systemic immune responses. Long-term vedolizumab therapy in patients with Crohn's disease and ulcerative colitis was safe and effective. Additionally, vedolizumab can be used in patients already failed an anti-TNF therapy. Ustekinumab is a fully human immunoglobulin G1 kappa monoclonal antibody that blocks the p40 subunit of IL-12 and IL-23. Ustekinumab will be a clinically effective agent to use in medically-refractory Crohn's disease especially as a second line drug. Tofacitinib is an oral, small molecule that inhibits JAK1, JAK3 and in a lesser extent, JAK2. Perhaps the most attractive things of these JAK inhibitors is that they are given orally instead of parenterally. Early results showed that patients with moderately to severely active ulcerative colitis receiving tofacitinib were more likely to achieve remission at 8 weeks than those receiving placebo. However, these results have not been as robust in Crohn's disease. Much of the positioning will depend on the safety profile such as opportunistic infection and atherogenic risk. The challenges for the future are to determine the therapeutic drug monitoring-guided dose optimization, optimal timing and drug combinations to produce the most effective, and safest outcomes for IBD patients.

4. Australia pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of inflammatory bowel disease. [2018] Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases that have been treated with corticosteroids, 5-aminosalicates and thiopurines, but therapeutic options have been broadened with the arrival of anti-tumor necrosis factor antibodies. In this article we reviewed the current evidence-based approach to inflammatory bowel disease, the modifications that have been made to existing therapies and discussed new drugs that have shown success in clinical trials. The new drugs discussed here are those that disturb lymphocyte homing to the gut (natalizumab, vedolizumab and anti-mucosal addressin cellular adhesion molecule); one that blocks interleukin (IL)-12 as well as the IL-23/T helper 17 (Th17) axis (ustekinumab) and one that blocks the signaling of multiple cytokines (tofacitinib).

5. England pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022] Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease.