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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522511-42 | Registry Identifier | CTIS | |
| U1111-1321-1765 | Registry Identifier | WHO ICTRP |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD cohort: balinatunfib dose regimen 1 | Experimental | Participants will receive balinatunfib dose regimen 1 |
|
| CD cohort: balinatunfib dose regimen 2 | Experimental | Participants will receive balinatunfib dose regimen 2 |
|
| CD cohort: balinatunfib dose regimen 3 | Experimental | Participants will receive balinatunfib dose regimen 3 |
|
| CD cohort: Placebo | Placebo Comparator | Participants will receive balinatunfib-matching placebo |
|
| UC cohort: balinatunfib dose regimen 1 | Experimental | Participants will receive balinatunfib dose regimen 1 |
|
| UC cohort: balinatunfib dose regimen 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balinatunfib | Drug | Pharmaceutical form:Tablet -Route of administration:Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) | 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) | Up to End of Study (approximately 106 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Participants with UC
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:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 1000001 | Gorna Oryahovitsa | 5100 | Bulgaria | |||
| Investigational Site Number : 1520010 |
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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Blinding is not applicable for open-label arms.
Participants will receive balinatunfib dose regimen 2
|
| UC cohort: balinatunfib dose regimen 3 | Experimental | Participants will receive balinatunfib dose regimen 3 |
|
| UC cohort: Placebo | Placebo Comparator | Participants will receive balinatunfib-matching placebo |
|
|
| balinatunfib-matching placebo | Drug | Pharmaceutical form:Tablet -Route of administration:Oral |
|
| 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. | 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. | 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. | 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 | 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 | Week 104 |
| Santiago |
| Reg Metropolitana de Santiago |
| 8331143 |
| Chile |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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