A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (SUNSCAPE-2)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Duvakitug

Study type: Interventional

Funder types: Industry

Identifiers

NCT07185009

EFC18359

2025-521038-27 (Registry Identifier)

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).

Study details include:

The study duration may be up to 286 weeks including:

• 40-week Pivotal Maintenance Sub-Study
• 240-week Open-Label Extension (OLE) Sub-Study
• 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.

The treatment duration may be up to 280 weeks including:

• 40 weeks in Pivotal Maintenance Sub-Study
• 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

• 21 visits in the Pivotal Maintenance Sub-Study.
• 11 visits in the OLE Sub-Study.

Enrollment: 671 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
• Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1
• OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Exclusion criteria

• Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
• Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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671 participants in 4 patient groups, including a placebo group

Duvakitug - dose 1

Experimental group

Description:

Subcutaneous (SC) injection as per protocol

Treatment:

Drug: Duvakitug

Duvakitug - dose 2

Experimental group

Description:

SC injection as per protocol

Treatment:

Drug: Duvakitug

Duvakitug - dose 3

Experimental group

Description:

SC injection as per protocol

Treatment:

Drug: Duvakitug

Placebo

Placebo Comparator group

Description:

SC injection as per protocol

Treatment:

Drug: Placebo