Colitis UlcerativePhase 2NCT07222189
A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS)
A Phase 2 study testing balinatunfib in people with Colitis Ulcerative and Crohn's Disease, run by Sanofi at 10 sites in 7 countries.
Trial summary
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212)… Read more about this study
- Who is it for?
- Ages 19 to 77 years
- Conditions the study is for
- Colitis Ulcerative, Crohn's Disease
- What is being tested?
- balinatunfib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 19 May 2026to 15 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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
- who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study;
- who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study.
- OR
Show all 10Show fewer
- Participants with UC
- who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study;
- who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
- 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
Who cannot join
- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
- 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.
- 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.
- 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.
- 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.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Chile3 sites
Investigational Site Number : 1520016
Santiago, Reg Metropolitana de Santiago, 7500010
Investigational Site Number : 1520010
Santiago, Reg Metropolitana de Santiago, 8331143
Investigational Site Number : 1520012
Santiago, Reg Metropolitana de Santiago, 8380456
China2 sites
Investigational Site Number : 1560002
Guangzhou, 510080
Investigational Site Number : 1560032
Shanghai, 200120
United States1 site
Texas Digestive Disease Consultants - Southlake- Site Number : 8400005
Southlake, Texas, 76092
About this study
Official title: A Multinational, Multicenter Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Adults With Crohn's Disease or Ulcerative Colitis
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively.
- The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period.
- The study will consist of 2 independent cohorts through the study given the distinct nature of each disease:
- CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212).
- UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822).
- The study will consist of the following study periods for each cohort:
- A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies.
- An Open-Label (OL) treatment period of up to 104 weeks for:
- Eligible participants from either the DB or OL periods of the parent studies,
- Eligible participants who meet escape criteria at any time during the DB period of the LTS19689.
- A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.
- Conditions
- Colitis Ulcerative, Crohn's Disease
- Being tested
- balinatunfib, balinatunfib-matching placebo
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balinatunfibDrug
Also called SAR441566
Pharmaceutical form:Tablet -Route of administration:Oral
balinatunfib-matching placeboDrug
Pharmaceutical form:Tablet -Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| CD cohort: balinatunfib dose regimen 1 | Experimental | Participants will receive balinatunfib dose regimen 1 Receives: Drug: balinatunfib |
| CD cohort: balinatunfib dose regimen 2 | Experimental | Participants will receive balinatunfib dose regimen 2 Receives: Drug: balinatunfib |
| CD cohort: balinatunfib dose regimen 3 | Experimental | Participants will receive balinatunfib dose regimen 3 Receives: Drug: balinatunfib |
| CD cohort: Placebo | Placebo comparator | Participants will receive balinatunfib-matching placebo Receives: Drug: balinatunfib-matching placebo |
| UC cohort: balinatunfib dose regimen 1 | Experimental | Participants will receive balinatunfib dose regimen 1 Receives: Drug: balinatunfib |
| UC cohort: balinatunfib dose regimen 2 | Experimental | Participants will receive balinatunfib dose regimen 2 Receives: Drug: balinatunfib |
| UC cohort: balinatunfib dose regimen 3 | Experimental | Participants will receive balinatunfib dose regimen 3 Receives: Drug: balinatunfib |
| UC cohort: Placebo | Placebo comparator | Participants will receive balinatunfib-matching placebo Receives: Drug: balinatunfib-matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Measured: Up to End of Study (approximately 106 weeks)
Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Measured: Up to End of Study (approximately 106 weeks)
Secondary outcomes (6)
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Measured: Week 52
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Measured: Week 104
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease.
Measured: Week 52
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease.
Measured: Week 104
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity
Measured: Week 52
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity
Measured: Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start19 May 2026
- Primary completion29 Sep 2026
- Study completion15 Oct 2026
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis UlcerativeStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222189
- Sponsor's protocol ID
- LTS19689
- Other IDs
- 2025-522511-42, U1111-1321-1765, 2025
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Adults With Crohn's Disease or Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07222189
- Acronym / sponsor ID
- LTS19689
- Conditions
- Colitis Ulcerative, Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively.
- The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period.
- The study will consist of 2 independent cohorts through the study given the distinct nature of each disease:
- CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212).
- UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822).
- The study will consist of the following study periods for each cohort:
- A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies.
- An Open-Label (OL) treatment period of up to 104 weeks for:
- Eligible participants from either the DB or OL periods of the parent studies,
- Eligible participants who meet escape criteria at any time during the DB period of the LTS19689.
- A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| CD cohort: balinatunfib dose regimen 1 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 1 |
| CD cohort: balinatunfib dose regimen 2 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 2 |
| CD cohort: balinatunfib dose regimen 3 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 3 |
| CD cohort: Placebo | Placebo comparator | Drug: balinatunfib-matching placeboParticipants will receive balinatunfib-matching placebo |
| UC cohort: balinatunfib dose regimen 1 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 1 |
| UC cohort: balinatunfib dose regimen 2 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 2 |
| UC cohort: balinatunfib dose regimen 3 | Experimental | Drug: balinatunfibParticipants will receive balinatunfib dose regimen 3 |
| UC cohort: Placebo | Placebo comparator | Drug: balinatunfib-matching placeboParticipants will receive balinatunfib-matching placebo |
Who may qualify
- Ages
- 19 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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:
- OR
- 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
Key exclusion criteria (7 listed)
- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balinatunfibAlso: SAR441566Pharmaceutical form:Tablet -Route of administration:Oral | Drug | CD cohort: balinatunfib dose regimen 1, CD cohort: balinatunfib dose regimen 2, CD cohort: balinatunfib dose regimen 3, UC cohort: balinatunfib dose regimen 1, UC cohort: balinatunfib dose regimen 2, UC cohort: balinatunfib dose regimen 3 |
| balinatunfib-matching placeboPharmaceutical form:Tablet -Route of administration:Oral | Drug | CD cohort: Placebo, UC cohort: Placebo |
Primary outcome
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Up to End of Study (approximately 106 weeks)
Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Up to End of Study (approximately 106 weeks)
6 secondary outcomes
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Time frame: Week 52
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Time frame: Week 104
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Time frame: Week 52
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Time frame: Week 104
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Time frame: Week 52
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Time frame: Week 104
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- LTS19689 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing balinatunfib in people with Colitis Ulcerative and Crohn's Disease, run by Sanofi at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Chile, China, United States, Argentina, Bulgaria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) (time frame: Up to End of Study (approximately 106 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.