Ensayos clínicos

Inclusion Criteria:

• Subjects who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
• Subjects have completed the study M16-006 or M15-991 and have achieved clinical response.
• Main entry criteria for Study M16-006 and Study M15-991:
  • Males and females aged ≥ 18 to ≤ 80 years of age, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible ≥ 16 to < 18 years of age who meet the definition of Tanner stage 5 development;
  • Moderately to severely active CD, defined as average daily SF ≥ 4 and/or average daily AP score ≥ 2;
  • Endoscopic evidence of mucosal inflammation (Simple Endoscopic Score for CD [SES-CD], excluding the presence of narrowing component, ≥ 3 as confirmed by a centrally read endoscopy. During the COVID-19 pandemic the final endoscopy post-induction treatment may not be conducted due to local regulation prohibiting endoscopy and subjects may be allowed to enroll in SS 3 should they meet clinical response.
• Main entry criteria for all other subjects:
  • Patients with Crohn's disease, who have successfully completed another AbbVie risankizumab Crohn's disease study.

Exclusion Criteria:

• Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the subject unsuitable for this study.
• Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
• Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
• Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.