An induction study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

2 Mar 2026 → ongoing

Decision date (initial)

2026-02-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-521035-37-00

WHO UTN

U1111-1315-4455

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To assess the efficacy of duvakitug as induction therapy in the treatment of moderately to severely active UC compared to placebo.

Secondary objectives 3

1. To assess the efficacy of duvakitug using multiple measures of disease activity.
2. To assess the safety of duvakitug as induction therapy compared to placebo in participants with moderately to severely active UC.
3. To evaluate the Pharmacokinetics (PK) and immunogenicity of duvakitug

Conditions and MedDRA coding

Immune system diseases

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003647-PIP01-24

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development
2. Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline
3. Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies

Exclusion criteria 7

1. Participants with Crohn’s Disease (CD), indeterminate colitis
2. Current diagnosis of Ulcerative Proctitis
3. Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of >3 bowel resections
4. Prior or current high-grade gastrointestinal (GI) dysplasia
5. Participants on treatment with but not on stable doses of conventional therapies prior to baseline
6. Participants with prohibited medications or therapies prior to baseline
7. Participants with previous exposure to anti-TL1A investigational therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving clinical remission.

Secondary endpoints 16

1. Proportion of participants who achieve endoscopic improvement.
2. Proportion of participants achieving clinical response by modified Mayo Score (mMS).
3. Proportion of participants achieving histological endoscopic mucosal improvement.
4. Change from baseline in PROMIS-Fatigue Short Form 7a T-score.
5. Proportion of participants with symptomatic (SFS and RBS) remission
6. Proportion of participants with no bowel urgency
7. Proportion of participants reporting no nocturnal bowel movements
8. Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.
9. Proportion of participants who achieve endoscopic remission.
10. Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).
11. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
12. Proportion of participants with UC-related hospitalization
13. Proportion of participants achieving clinical remission and no steroid use.
14. Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment- Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and Treatment-Emergent Adverse Events (TEAEs) leading to permanent study intervention discontinuation.
15. Serum concentration of duvakitug measured over time.
16. Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 16

Locations

15 EU/EEA countries · 134 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 208 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications