A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

671 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-07

Study Completion Date

2033-04-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Duvakitug - dose 1

Subcutaneous (SC) injection as per protocol

Group Type EXPERIMENTAL

Duvakitug

Intervention Type DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Duvakitug - dose 2

SC injection as per protocol

Group Type EXPERIMENTAL

Duvakitug

Intervention Type DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Duvakitug - dose 3

SC injection as per protocol

Group Type EXPERIMENTAL

Duvakitug

Intervention Type DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Placebo

SC injection as per protocol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pharmaceutical form:Injection solution-Route of administration:SC injection

Interventions

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Duvakitug

Pharmaceutical form: Injection solution Route of administration: SC injection

Intervention Type DRUG

Placebo

Pharmaceutical form:Injection solution-Route of administration:SC injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No