An induction study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease

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

23 Mar 2026 → ongoing

Decision date (initial)

2026-03-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-521036-11-00

WHO UTN

U1111-1314-5319

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

Sub-Study 2: To assess the efficacy of duvakitug as induction therapy in participants with moderately to severely active CD compared with placebo.

Secondary objectives 3

1. Sub-Study 2: To assess the efficacy of duvakitug by multiple measures of disease activity.
2. Sub-Study 2: To evaluate the safety of duvakitug as induction therapy in participants with moderately to severely active CD compared with placebo.
3. Sub-Study 2: To evaluate the PK and immunogenicity of duvakitug in participants with moderately to severely active CD.

Conditions and MedDRA coding

Immune system disseases

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-000000-PIP00-00

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 Crohn’s Disease (CD) 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 (ATs)

Exclusion criteria 6

1. Participants with Ulcerative Colitis (UC) or indeterminate colitis
2. Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
3. Prior or current high-grade gastrointestinal (GI) dysplasia
4. Participants on treatment with but not on stable doses of conventional therapy prior to baseline
5. Participants receiving prohibited medications or therapies
6. Participants with previous exposure to anti-TL1A investigational therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12
2. Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12
3. Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12
4. Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12

Secondary endpoints 17

1. Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12
2. Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12
3. Sub-study 2: Proportion of participants achieving endoscopic SES- CD remission at Week 12
4. Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12
5. Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12
6. Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12
7. Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12
8. Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4
9. Sub-study 2: US/FDA: Proportion of participants achieving corticosteroid free remission (in the subset of participants with corticosteroids at baseline) per CDAI at Week 12
10. Sub-study 2: EU/EMA: Proportion of participants achieving corticosteroid free remission per PRO-2 (in the subset of participants with corticosteroids at baseline) at Week 12
11. Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12
12. Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
13. Sub-study 2: Proportion of participants with no bowel urgency by Numeric Rating Scale (NRS) at Week 12
14. Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12
15. Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), treatment-emergent adverse event of special interest (TEAESIs), treatment-emergent serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation
16. Sub-study 2: Serum concentrations of duvakitug
17. Sub-study 2: 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 Services and operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Services and operations

Third parties 7

Locations

15 EU/EEA countries · 142 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 219 files

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

Application history

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