Duvakitug for Crohn's Disease

(STARSCAPE-2 Trial)

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Hypersensitivity to duvakitug, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 43

671 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called duvakitug for individuals with moderately to severely active Crohn's Disease. Researchers aim to evaluate the effectiveness and long-term safety of duvakitug. Participants will receive varying doses of duvakitug or a placebo (a no-treatment injection) to compare effects. Ideal candidates are those whose Crohn's Disease significantly impacts their daily life. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants an opportunity to contribute to a treatment that could soon become widely available.

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's best to discuss this with the study team or your doctor.

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

Research has shown that duvakitug has promising safety results from earlier studies. These studies found that patients with moderate to severe Crohn's disease generally tolerated it well. No major safety issues emerged, and side effects were similar to those seen with placebo treatments. Although duvakitug remains under study and has not yet received approval from health authorities, these early findings suggest it could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Duvakitug for Crohn's Disease because it offers a potentially new way to manage this challenging condition. Unlike many existing treatments that focus on suppressing the immune system broadly, Duvakitug is designed to target specific pathways involved in inflammation, which could lead to more effective and tailored symptom control. Additionally, Duvakitug is administered via subcutaneous injection, which might be more convenient compared to some current intravenous therapies. This combination of targeted action and easier administration could make Duvakitug a promising option for patients seeking better management of their symptoms.

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

Research has shown that duvakitug may help treat Crohn's disease. In this trial, participants will receive different doses of duvakitug or a placebo. Studies have found that a significant number of patients experienced clinical remission, meaning their symptoms improved. Specifically, 36% of patients taking a 450 mg dose and 48% taking a 900 mg dose saw improvement, compared to only 20% of those taking a placebo, which is a non-active treatment. Additionally, duvakitug outperformed the placebo in improving the condition of the intestines by week 14. These findings suggest that duvakitug could be a helpful treatment for people with moderately to severely active Crohn's disease. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 with moderately to severely active Crohn's Disease. It includes those who responded well clinically and completed endoscopy in a previous study, or finished the main part of this study. Younger participants may join if they're fully developed as per Tanner stage 5.

Inclusion Criteria

I am between 18 and 80 years old, or 16-18 with full development.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pivotal Maintenance Sub-Study

Participants receive the study medication or placebo for maintenance of Crohn's Disease

40 weeks

21 visits (in-person)

Open-Label Extension (OLE) Sub-Study

Participants may continue to receive the study medication in an open-label format

240 weeks

22 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

45 days

What Are the Treatments Tested in This Trial?

Interventions

• Duvakitug

Trial Overview The trial tests Duvakitug against a placebo over up to 286 weeks, including a pivotal maintenance phase and an open-label extension where everyone gets Duvakitug. Participants will visit the clinic up to 43 times for assessments.

How Is the Trial Designed?

Group I: Duvakitug dose 1 Experimental Treatment 1 Intervention

Subcutaneous (SC) injection as per protocol

Group II: Du vakitug dose 3 Experimental Treatment 1 Intervention

SC injection as per protocol

Group III: Du vakitug dose 2 Experimental Treatment 1 Intervention

SC injection as per protocol

Group IV: Placebo Placebo Group 1 Intervention

SC injection as per protocol

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Teva Branded Pharmaceutical Products R&D LLC

Industry Sponsor

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-02-22-07-30-00-3030764

Press Release: ECCO 2025: new duvakitug data reinforce ... ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease. New detailed data from the ...

2. gi.org gi.org/media/press-info-scientific-meeting/featured-science/oral-66-duvakitug-an-anti-tl1a-mab-demonstrates-efficacy-and-favorable-safety-as-an-induction-treatment-in-adults-with-moderately-to-severely-active-crohns-disease-resu/

Oral 66 – Duvakitug, an anti-TL1a mAb, Demonstrates ... The primary induction results showed that 26% (450 mg) and 48% (900 mg) of patients with CD treated with duvakitug achieved the primary endpoint ...

3. healio.com healio.com/news/gastroenterology/20251103/duvakitug-delivers-strong-early-results-in-very-first-anti-tl1a-trial-for-crohns

Duvakitug delivers strong early results in 'very first' anti- ... PHOENIX — Duvakitug outperformed placebo at week 14 in endoscopic response and was well tolerated among patients with moderately to severely ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07184944

NCT07184944 | A Maintenance Study to Investigate the ... Clinical Remission 2-item patient-reported outcome (PRO-2): average daily stool frequency (SF) ≤3 and not worse than the Baseline, and average ...

5. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i79/7966919

OP41 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... Both duvakitug doses successfully achieved the week 14 primary endpoint of clinical remission (36% [450 mg], 48% [900 mg] versus 20% [PBO]; PBO- ...

6. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i77/7966998

OP40 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... Duvakitug has demonstrated reduced inflammation and fibrosis in colitis animal models.1 Few data are available for the potential of anti-TL1A ...