Health Condition 1: K509- Crohns disease, unspecified
Conditions
Interventions
Intervention1: SAR441566: Dose formulation: Oral
Unit dose strength(s): 100 mg
Intervention name:Balinatunfib
Arm 200 mg BID: 4 tablets of balinatunfib 100 mg daily.
Arm 100 mg BID: 2 tablets of
Sponsors
Sanofi Healthcare India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: I 01. Participants with CD or UC who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively: Participants with CD i) who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study. ii) who complete open label treatment and achieve a combination of clinical response or clinical remission by CDAI AND endoscopic response or endoscopic remission by SES- CD at Week 52 of SPECIFI-CD (DRI18212) study. OR Participants with UC i) who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study, ii) who complete open-label treatment and achieve mMS clinical response or mMS clinical remission at Week 52 of SPECIFI-UC (DRI17822) study. Sex, contraceptive/barrier method and pregnancy testing requirements/breastfeeding I 02. All Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) Male participants: Male participants who are sexually active with female partner(s) of childbearing potential must agree to practice the protocol-specified contraception during the study and for up to 3 months, after the last dose of study intervention which will allow for one complete cycle of spermatogenesis following study drug discontinuation. Males must refrain from donating sperm during the study treatment period and for up to 3 months after the last dose of study intervention. b) Female participants: --A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: ---Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4 of the protocol. OR ---Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), preferably with low user dependency, as described in Section 10.4 of the protocol during the study intervention period (to be effective before starting the intervention) and for at least 3 months after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period. --A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at screening and a negative urine pregnancy test before the first administration of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. I 03. WONCBP may participate and include who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as M llerian agenesis; or post-menopausal - defined as either: -- A woman more than equal to 50 years of age with an intact uterus, not on hormone therapy, who has had either ---cessation of menses for at least 1 year, or ---at least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone (FSH) more than 40 mIU/mL, -- A woman more than equal to 55 years of age not on hormone therapy, who has had at lea
Exclusion criteria
Exclusion criteria: Medical conditions E 01. Participants with CD who develop a new medical condition precluding participation as described in Section 5.2 Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol. E 02. Participants with UC who develop a medical condition precluding participation as described in Section 5.2 Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol. E 03. 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. E 04. 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. E 05. 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. E 06. 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 (Table 5, Section 6.9.1) concomitant with IMP or during a temporary IMP discontinuation period. Diagnostic assessments E 07. At baseline visit, participants with a prolongation of QTc interval (QTcF more than 450 msec) or personal or family history of long QT syndrome. Other exclusion criteria E 08. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. E 09. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. E 10. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6). E 11. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. E 12. Any country-related specific regulation that would prevent the participant from entering the study see Appendix 8 (Section 10.8) country-specific/region requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the long-term safety and tolerability of different doses of balinatunfib in participants with Crohn s disease (CD) or ulcerative colitis (UC).Timepoint: 104 week | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term efficacy of different doses of balinatunfib in participants with CD.Timepoint: 104 weeks ;To evaluate the long-term efficacy of different doses of balinatunfib in participants with UC.Timepoint: 104 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Netherlands, Poland, South Africa, Spain, Turkey, United States of America
Contacts
Public ContactLaxman Deshmukh
Sanofi Healthcare India Private Limited
Outcome results
None listed