A study to investigate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn’s disease or ulcerative colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-03-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-522511-42-00

WHO UTN

U1111-1324-1765

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To assess the long-term safety and tolerability of different doses of balinatunfib in participants with Crohn’s disease (CD) or ulcerative colitis (UC)

Secondary objectives 2

1. To evaluate the long-term efficacy of different doses of balinatunfib in participants with CD
2. To evaluate the long-term efficacy of different doses of balinatunfib in participants with UC

Conditions and MedDRA coding

Crohn's disease

Regulatory references

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 2

1. Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively: · Participants with CD 1. who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study. OR · Participants with UC 1. who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study; 2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
2. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Exclusion criteria 6

1. Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
2. Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
3. Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator’s medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
4. Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.
5. Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.
6. Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
2. Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

Secondary endpoints 6

1. Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD)
2. Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn’s disease (SES-CD)
3. Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI)
4. Proportion of participants with Crohn's Disease in clinical remission based on Crohn’s disease activity index (CDAI)
5. Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
6. Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)

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 5

Locations

14 EU/EEA countries · 68 investigational sites

By country

Investigational sites

Results and documents

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

Documents 82 files

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

Application history

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