Vedolizumab + IL-23 Antagonists for Crohn's Disease

(VOICE Trial)

Recruiting at 20 trial locations

Overseen By Heather MacAulay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alimentiv Inc.

Must be taking: Vedolizumab, IL-23 antagonists

Must not be taking: Anti-integrin, anti-IL, JAK inhibitors

Disqualifiers: CD surgery, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how people with Crohn's disease respond to two treatments: Vedolizumab, a biologic medication, and IL-23 antagonists, drugs targeting specific proteins involved in inflammation. Researchers aim to assess how these treatments affect daily life aspects such as pain, fatigue, anxiety, and sleep. Individuals with active Crohn's disease starting one of these treatments for the first time might be suitable participants. The study seeks to understand the impact of these medications on overall well-being. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It seems you can continue with your existing treatments unless they conflict with the trial's specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have found IL-23 inhibitors to be generally safe, with serious side effects, such as infections, being rare and similar to those of other long-term treatments. Another study confirmed the relative safety of IL-23 inhibitors for the conditions they treat.

Research also shows that Vedolizumab has a strong safety record, with serious infections and other major side effects being uncommon. Data from several studies indicate that Vedolizumab is safe for long-term use in adults with Crohn's Disease and ulcerative colitis.

Both treatments have undergone safety studies and are generally well-tolerated, with few serious risks reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Crohn's Disease because they offer new ways to manage inflammation in the gut. Unlike many standard treatments that broadly suppress the immune system, IL-23 antagonists specifically target the IL-23 pathway, which is crucial in the inflammatory process of Crohn's Disease. Vedolizumab, on the other hand, works by blocking certain white blood cells from reaching the gut lining, which reduces inflammation without widespread immune suppression. These targeted approaches mean potentially fewer side effects and more effective management of symptoms, which is why they are generating interest in the medical community.

What evidence suggests that this trial's treatments could be effective for CD?

This trial will compare Vedolizumab with IL-23 antagonists for treating Crohn's Disease. Research has shown that Vedolizumab helps about 39% of patients feel better and reduces symptoms after one year. It also enables some patients to reduce or stop steroid use. IL-23 blockers have demonstrated significant results in improving symptoms for conditions like psoriasis, which is similar to Crohn's, with over 70% of patients benefiting. Although specific data for Crohn's is limited, IL-23 blockers are believed to manage inflammation effectively. Both treatments offer potential benefits, but more information on IL-23 blockers for Crohn's Disease would be useful. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

My score is based on adding points from 8 different areas.

I have completed all required health checks for infections and vaccinations.

I understand the study and agree to participate in all parts of it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vedolizumab or IL-23 antagonists as part of routine care, with dose, frequency, and duration determined by the healthcare provider

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vedolizumab

How Is the Trial Designed?

Group I: Vedolizumab Experimental Treatment 1 Intervention

Group one will include participants who will be starting Vedolizumab as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.

Group II: IL-23 Antagonists Experimental Treatment 2 Interventions

Group two will include participants who will be starting an IL-23 antagonist as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.

Who Is Running the Clinical Trial?

Alimentiv Inc.

Lead Sponsor

Trials

15

Recruited

3,300+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12425355/

Real-world analysis of IL-23 inhibitors in patients with ... Conclusion. IL-23 inhibitors have proven effective in managing both skin and joint symptoms in patients with psoriasis at risk for PsA.

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)01750-1/abstract

IL-23 inhibition for chronic inflammatory disease Pooled clinical trial data show objective disease improvement for more than 70% of patients with psoriasis and up to 50% of patients with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10425519/

Efficacy and safety of IL-23 inhibitors in the treatment ... In terms of our primary outcome, ACR20, the IL-23 inhibitor group showed significantly higher response rates compared to the placebo group, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07184138

Real-World Study on the Safety and Effectiveness of IL-23 ... However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1669786/pdf

Clinical benefits and complication profile of IL-23 inhibitors ... IL-. 23 inhibition also resulted in superior MDA (RR = 2.85; 95% CI: 2.30–3.54), and better resolution of enthesitis (RR = 1.46; 95% CI: 1.29– ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39833957/

Adverse events associated with IL-23 and IL-12/ ... This study aims to provide a comprehensive examination of the distribution and characteristics of these AEs concerning IL-23 and IL-12/23 inhibitors.

7. bmcpharmacoltoxicol.biomedcentral.com bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-025-00837-y

Adverse events associated with IL-23 and IL-12/23 inhibitors ... IL-12/23 and IL-23 inhibitors are considered relatively safe treatment options in the management of their indicated diseases [19], such as ...

8. ajmc.com ajmc.com/view/il-23-long-term-data-and-safety-data

IL-23: Long-term Data and Safety Data A review of the IL-23 inhibitors and their long-term and safety data. Transcript. Peter L. Salgo, MD: All right, let's talk about some of the newer biologics ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10329957/

Safety of IL-23 p19 Inhibitors for the Treatment of Patients ... The favorable safety profiles of IL-23 p19 inhibitors support their long-term use in the management of patients with moderate-to-severe psoriasis.