Duvakitug for Ulcerative Colitis

(SUNSCAPE-1 Trial)

Recruiting at 37 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Prohibited medications

Disqualifiers: Crohn's disease, Ulcerative proctitis, 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: 24

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 for individuals with moderately to severely active Ulcerative Colitis (UC), a condition causing inflammation and sores in the colon. The trial aims to evaluate the effectiveness and safety of duvakitug compared to a placebo. Participants will receive the treatment through subcutaneous (under the skin) injections. Ideal candidates have had UC for at least three months and have not responded well to other treatments. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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

The trial protocol does not clearly specify if you need to stop your current medications. However, it mentions that participants should not be on unstable doses of conventional therapies or prohibited medications before starting the trial.

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

A previous study found that duvakitug was generally well-tolerated by people with ulcerative colitis and Crohn's disease. The research identified no new safety concerns, and higher doses did not worsen problems. This suggests that duvakitug might be safe for use based on current information. However, it remains under study, and health authorities have not yet confirmed its complete safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Ulcerative Colitis?

Researchers are excited about Duvakitug for ulcerative colitis because it offers a potentially novel approach compared to current treatments. Unlike standard options that often involve oral medications like mesalamine or immunosuppressants, Duvakitug is administered through a subcutaneous injection, which might be more convenient for some patients. Additionally, Duvakitug could work through a different mechanism of action, potentially offering relief to those who haven't responded well to existing therapies. This fresh approach has the potential to improve both the effectiveness and ease of treatment for ulcerative colitis sufferers.

What evidence suggests that duvakitug might be an effective treatment for ulcerative colitis?

Research has shown that duvakitug may help treat ulcerative colitis (UC). In this trial, participants will receive either a lower dose or a higher dose of duvakitug, or a placebo. One study found that 36% of patients taking a lower dose and 48% taking a higher dose of the drug experienced significant symptom relief, compared to only 20% of those taking a placebo. This indicates that many patients had fewer or no symptoms after treatment. Another study confirmed that duvakitug improved both symptoms and visible signs of UC in the gut. These findings suggest that duvakitug could be a strong option for people with moderate to severe UC. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with moderately to severely active Ulcerative Colitis (UC) who haven't responded well to other treatments. It's also open, where allowed, to individuals aged 16-18 at Tanner Stage 5 development. Participants must have been diagnosed with UC for at least three months.

Inclusion Criteria

I have been diagnosed with moderate to severe ulcerative colitis for at least 3 months.

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

My condition did not improve with standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sub-Study 1 or Sub-Study 2 Induction

Participants undergo a 12-week induction phase with either a single-arm open-label feeder induction or a pivotal induction

12 weeks

Up to 8 visits (in-person)

Sub-Study 3 Extended Induction

Non-responders from the initial induction phase undergo an additional 12-week extended induction

12 weeks

Up to 15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment if they do not enroll into the maintenance study

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Duvakitug

Trial Overview

The study tests Duvakitug against a placebo in people with UC over up to 35 weeks. It includes initial treatment phases and an extended phase for non-responders, followed by a maintenance study or follow-up visit.

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 ...

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

2.

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- ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07185009

NCT07185009 | A Maintenance Study to Investigate the ...

... Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis. Conditions. Ulcerative Colitis.

4.

hcplive.com

hcplive.com/view/relieve-uccd-duvakitug-improves-clinical-endoscopic-outcomes-uc-subgroups

RELIEVE-UCCD: Duvakitug Improves Clinical, Endoscopic ...

The RELIEVE-UCCD study showed duvakitug's efficacy in achieving clinical remission and endoscopic improvement in moderate to severe UC.

5.

ddw-online.com

ddw-online.com/new-data-indicate-duvakitug-could-transform-ibd-treatment-33728-202502/

New data indicate duvakitug could “transform” IBD treatment

In the CD cohort, 26% (450mg dose) and 48% (900mg dose) of patients treated with duvakitug achieved the primary endpoint of endoscopic response ...

6.

sanofi.com

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

Press Release: Duvakitug positive phase 2b results ...

Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority. About IBD

7.

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 ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07184996

NCT07184996 | An Induction Study to Investigate the ...

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug ...