Duvakitug for Crohn's Disease

(STARSCAPE-1 Trial)

Recruiting at 19 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Anti-TL1A therapy

Disqualifiers: Ulcerative colitis, GI dysplasia, 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: 8

980 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 to determine its effectiveness for Crohn's Disease, a condition that inflames the digestive system, causing stomach pain and other issues. The trial compares two different doses of duvakitug to a placebo, a harmless substance used for comparison. It targets individuals who have had Crohn's Disease for at least three months and have not responded well to other treatments. Participants will receive injections and join one of three sub-studies to evaluate the treatment's efficacy and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not clearly state if you must stop your current medications, but it mentions that participants should not be on unstable doses of conventional therapy or receiving prohibited medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that duvakitug is likely to be safe for humans?

Research shows that duvakitug, the treatment being tested, is generally well-tolerated by patients. In earlier studies, duvakitug proved safe as an initial treatment for Crohn's disease, with most participants not experiencing serious side effects. In fact, duvakitug led to greater symptom improvement compared to a placebo, a substance with no active drug used for comparison. This indicates that people who took duvakitug felt better with few reports of problems.

Early results also demonstrated that duvakitug was well tolerated with no major safety concerns. While this is promising, it is important to note that the treatment is still under study and has not been approved by health authorities for use in any condition yet. The ongoing research aims to confirm these findings and ensure the treatment is safe for all patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's Disease?

Unlike the standard treatments for Crohn's Disease, which often include anti-inflammatory drugs, immunosuppressants, and biologics targeting specific proteins, Duvakitug offers a unique approach. This drug is administered through a subcutaneous injection, which might be more convenient for some patients compared to intravenous infusions required by other biologics. Researchers are particularly excited about Duvakitug because it potentially targets a novel pathway involved in the inflammation process, which could lead to improved outcomes for patients who don't respond well to current therapies.

What evidence suggests that duvakitug might be an effective treatment for Crohn's disease?

Research has shown that duvakitug may help treat Crohn's disease. In one study, 26% of patients taking a low dose and 48% taking a high dose saw significant improvement, compared to only 13% of those taking a placebo (a pill with no active medicine). Another study supported these findings, showing that duvakitug worked better than a placebo in improving patient well-being. Most participants tolerated the treatment well, experiencing no serious side effects. These results suggest that duvakitug could be a good option for people with moderate to severe Crohn's disease. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-80 with moderately to severely active Crohn's Disease, who haven't had success with conventional or advanced therapies. Some younger participants (16-18) may qualify if they're fully physically developed. People can't join if they don't meet these criteria.

Inclusion Criteria

I am between 18 and 80 years old, or 16-18 in Tanner Stage 5 if allowed.

I have been diagnosed with Crohn's Disease for at least 3 months.

My condition did not improve with standard or advanced treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks

Induction Treatment

Participants receive duvakitug or placebo in a double-blind manner to evaluate efficacy and safety

12 weeks

Up to 8 visits for Sub-Study 1 and Sub-Study 2, up to 15 visits for Sub-Study 3

Extended Induction

Non-responders from initial induction may continue treatment in an extended induction phase

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Duvakitug

Trial Overview The trial is testing Duvakitug against a placebo in people with Crohn's Disease over up to 35 weeks. It includes an initial screening, two main study phases for responders and non-responders, and a follow-up period unless continuing in further studies.

How Is the Trial Designed?

Group I: Duvakitug Dose 2 Experimental Treatment 1 Intervention

SC injection as per protocol

Group II: Duvakitug Dose 1 Experimental Treatment 1 Intervention

Subcutaneous (SC) Injection as per protocol

Group III: 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 ... Press Release: ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07184944

NCT07184944 | A Maintenance Study to Investigate the ... See Delay Results Type in the Results Data ... Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease.

4. sanofi.com sanofi.com/en/media-room/press-releases/2024/2024-12-17-12-30-00-2998154

Press Release: Duvakitug positive phase 2b results ... * In patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response* compared to 13.0% on placebo, ...

5. 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 ...

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 ...