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Trial eligibility change
| eligibility_criteria | Inclusion Criteria: * Participants' body weight must be \>= 40 kg at Baseline. * Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available. * CDAI \>= 220 at Baseline. * Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader. * Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules. Exclusion Criteria: * Participant who demonstrated intolerance to p19 inhibitors, including risankizumab. * Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline. * Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline. | → | Inclusion Criteria: * Participants' body weight must be \>= 40 kg at Baseline. * Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available. * CDAI \>= 220 at Baseline. * Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader. * Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules. Exclusion Criteria: * Participant with history of intolerance to p19 inhibitors, including risankizumab. * Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline. |
Not scored.No materiality record exists yet for this event.
No other named entities identified.This event has no scored competitor read-through.
No real valuation-relevant phase transition on a resolved asset for this event.This section fires only when the event carries a resolved asset and a real phase change — not guessed for every event.