Research

Primary objective
Compare the effect of vedolizumab + upadacitinib combination therapy vs vedolizumab alone

Population
Adults with moderately to severely active Crohn’s disease

Induction phase (12 weeks)

• Group 1: Vedolizumab + upadacitinib
• Group 2: Vedolizumab + placebo
• Maintenance phase (40 weeks): Vedolizumab alone for responders

Number of participants
Approximately 396

Total study duration
70 weeks

Study type
Multi-centre, international trial

Primary objective
Assess the efficacy and safety of tulisokibart in patients with moderately to severely active ulcerative colitis

Population
Adults with moderately to severely active ulcerative colitis

Study structure

• Study 1: Induction (12 weeks) + maintenance (up to 52 weeks)
• Study 2: Induction only (12 weeks)
• Long-term extension: up to Week 156 for both studies

Primary efficacy endpoint
Clinical remission based on modified Mayo score at Week 12 (and Week 52 for Study 1)

Treatment regimen

• Tulisokibart IV and SC
• Placebo IV and SC

Number of participants
Approximately 1020

• ~ 720 in Study 1
• ~ 300 in Study 2
• ~ 50% previously exposed to advanced therapies (anit-TNF, anti-integrins, anti IL-23, anti-IL-12/23, JAK inhibitors, S1PR modulators)
• < 30% of pretreated patients will have failed ≥ advanced therapies

Total study duration
Up to 156 weeks

Study type
Multi-centre, international trial

Primary objective
Assess the efficacy and safety of tulisokibart in patients with moderately to severely active Crohn’s disease

Population
Adults with moderately to severely active Crohn’s disease

Study structure

• Study 1: Induction (12 weeks) + maintenance (up to 52 weeks)
• Study 2: Induction only (12 weeks)
• Long-term extension: possible up to Week 156 for both studies

Treatment regimen

• Tulisokibart IV and SC
• Placebo IV and SC

Number of participants

Approximately 1200

• ~ 720 in Study 1
• ~ 480 in Study 2
• Up to 65% with prior exposure to advanced therapies (anti-TNF, anti-integrin, anti-IL-23, anti-IL-12/23, JAK inhibitors)
• Maximum 30% of patients with failure of ≥3 advanced therapies

Total study duration
Up to 156 weeks

Study type
Multi-centre, international trial

Sponsor
Janssen Research & Development, LLC

Primary objective
Evaluate the efficacy, safety and tolerability of oral icotrokinra

Population
Adults with moderately to severely ulcerative colitis

Eligibility criteria

• Diagnosis of UC established at least 12 weeks before screening 
• Moderately to severely active UC based on endoscopic score
• Participants had either not responded well to, or were unable to tolerate, standard treatments and had not previously received advanced therapies (ADT-naïve), or had not responded to (primary or secondary nonresponse) or were unable to tolerate advanced therapies (biologics and/or advanced oral agents) used to treat UC (ADT-inadequate responders [IR])

Study structure

• Induction (12 weeks) + maintenance (up to 52 weeks)
• Long-term extension

Treatment regimen

• Icotrokinra Per Os
• Placebo Per Os

Number of participants

Approximately 882

Study type
Multi-centre, international trial

Sponsor
Janssen Research & Development, LLC

Primary objective
Evaluate the efficacy, safety and tolerability of oral icotrokinra

Population
Adults with moderately to severely active Crohn’s disease

Eligibility criteria

• Male or female aged 18-75 years old with diagnosis of CD for at least 30 days
• Confirmed diagnosis of moderately to severely active CD assessed endoscopic score 
• Moderately to severely active CD based on endoscopic score
• Participants had either not responded well to, or were unable to tolerate, standard treatments and had not previously received advanced therapies (ADT-naïve), or had not responded to (primary or secondary nonresponse) or were unable to tolerate advanced therapies (biologics and/or advanced oral agents) used to treat CD (ADT-inadequate responders [IR])

Study structure

• Induction (12 weeks) + maintenance (up to 52 weeks)
• Long-term extension

Treatment regimen

• Icotrokinra Per Os
• Placebo Per Os

Number of participants

Approximately 882

Study type
Multi-centre, international trial

Sponsor
Takeda Development Center Americas, Inc.

Primary objective
Evaluate the efficacy and safety of oral TAK-279 in subjects with moderately to severely active CD

Population
Adults with moderately to severely active Crohn’s disease

Eligibility criteria

• Diagnosis of Crohn’s disease established at least 12 weeks before screening 
• Moderately to severely active Crohn’s disease based on endoscopic score
• Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic or advanced therapy for CD

Study structure

• Induction (12 weeks)
• Maintenance (up to 52 weeks)

Treatment regimen

• TAK-279 (or Zasocitinib) Per Os
• Placebo Per Os

Number of participants

Approximately 268

Study type
Multi-centre, international trial

Objectives
The primary objective of the study is to estimate the incidence of post-operative recurrence in patients who have received adequate exposure to approved biologic therapies.

The secondary objective of the study is to determine whether response to certain drugs or recurrence of disease after surgery is related to genetic factors in patients with Crohn’s disease or ulcerative colitis, and whether biomarkers can predict response to treatment or recurrence of disease after surgery.

We aim to perform multi-omic analyses to provide personalized biomarker testing to predict treatment response and to understand who will not recur after a surgery.

Primary objective

• To identify biological determinants of response or non-response to targeted therapies

We aim to find biomarkers to provide personalized diagnostics to predict who will respond to treatment.

Population

• Diagnosis of IBD according to the investigator’s standard medical practice
• Subjects at the stage of initiating treatment with an advanced therapy and/or biologic therapy for IBD

Participants
500 patients

Total duration of participation
Up to 60 weeks

Primary objective
Compare non-inferiority of antiintegrin therapy to anti-TNFα and anti-IL23 biologics as first-line treatment for achieving 1-year corticosteroid-free endoscopic remission

Population
Participants who have not previously received biologic treatments for Crohn’s disease

Participants
297 patients

Total duration of participation
12 months

Primary objective
Evaluate the effectiveness of etrasimod therapy in patients with moderate to severe ulcerative colitis

Population
Patients with a confirmed diagnosis of moderate to severe ulcerative colitis who are going to receive etrasimod

Participants
Approximately 520 patients

Total duration of participation
Approximately 52 weeks