Tulisokibart for Crohn's Disease
Recruiting in Palo Alto (17 mi)
+316 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: Ulcerative colitis, Short bowel, Cancer, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
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 might be best to discuss this with the trial coordinators 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 targeting similar pathways could be beneficial for Crohn's disease.
12345Eligibility Criteria
This trial is for people with moderate to severe Crohn's Disease. Participants should have active symptoms and be willing to receive either an IV or SC injection of the study drug or placebo. Specific details on who can join are not provided, but typically participants must meet certain health criteria.Inclusion Criteria
I was diagnosed with Crohn's disease over 3 months ago.
I have not responded well to steroids, immunomodulators, or advanced therapies.
My Crohn's disease is moderate to severe.
Exclusion Criteria
I have been diagnosed with ulcerative colitis or indeterminate colitis.
I have or might have COVID-19.
I have previously been treated with tulisokibart or a similar medication.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction Treatment
Participants receive high or low dose IV tulisokibart or placebo for induction treatment
12 weeks
Maintenance Treatment
Participants receive high or low dose SC tulisokibart or placebo for maintenance treatment
40 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Extension
Participants may continue in a high or low dose SC tulisokibart regimen if they meet protocol-specific prerequisites
Participant Groups
The trial is testing Tulisokibart, given through IV or SC injections, against a placebo to see if it helps achieve clinical remission and endoscopic response in Crohn's Disease patients at weeks 12 and 52.
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 2: Low Dose InductionExperimental Treatment3 Interventions
Participants receive low dose IV tulisokibart.
Group II: Study 2: Low Dose ExtensionExperimental Treatment1 Intervention
Participants receive a low dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group III: Study 2: High Dose InductionExperimental Treatment2 Interventions
Participants receive high dose IV tulisokibart.
Group IV: Study 2: High Dose ExtensionExperimental Treatment1 Intervention
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group V: Study 1: Low Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Group VI: Study 1: Low Dose ExtensionExperimental Treatment2 Interventions
Participants receive a low dose SC tulisokibart and placebo regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group VII: Study 1: High Dose Induction, Low Dose MaintenanceExperimental Treatment3 Interventions
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Group VIII: Study 1: High Dose Induction, High Dose MaintenanceExperimental Treatment2 Interventions
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Group IX: Study 1: High Dose ExtensionExperimental Treatment1 Intervention
Participants receive a high dose SC tulisokibart regimen. Participants may continue in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Group X: Study 2: PlaceboPlacebo Group3 Interventions
Participants receive IV placebo.
Group XI: Study 1: PlaceboPlacebo Group3 Interventions
Participants receive IV placebo, followed by an SC placebo regimen.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atlantic Medical Research ( Site 5073)Margate, FL
Endoscopic Research Inc ( Site 5061)Orlando, FL
Digestive Health Specialists ( Site 5064)Dothan, AL
Peak Gastroenterology Associates ( Site 5023)Colorado Springs, CO
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLCLead Sponsor
References
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).
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.
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).
[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.
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.