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

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

• 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 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.
• 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.