Ulcerative Colitis (UC)
Conditions
Interventions
investigational material(s)
Generic name etc : Risankizumab (Genetical Recombination)
INN of investigational material : risankizumab
Therapeutic category code : 239 Other agents affecting digestive or
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Study M16-067 that in the Investigator's judgment makes the participant unsuitable for this study. 2. Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 3. Participant is not in compliance with prior and concomitant medication requirements throughout Study M16-067.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score [ Time Frame: Week 52 ] Clinical remission per Adapted Mayo Score. Sub-Study 3: Percentage of Participants with Adverse Events (AE) [ Time Frame: Up to Week 300 ] An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1. Sub-Study 1: Percentage of Participants with Endoscopic Improvement [ Time Frame: Week 52 ] Endoscopic improvement per endoscopy subscore. 2. Sub-Study 1: Percentage of Participants with Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ] Clinical remission per full Mayo Score. 3. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of induction). [ Time Frame: Week 52 ] Percentage of participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction). 4. Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0 [ Time Frame: Week 52 ] Clinical remission per Adapted Mayo Score. 5. Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, Remained Corticosteroid Free for 90 days and Achieved Clinical Remission in Participants who were Taking Steroids at Baseline (of induction) [ Time Frame: Week 52 ] Participants who discontinued corticosteroid use. 6. Sub-Study 1: Percentage of Participants with Clinical Response per Adapted Mayo Score [ Time Frame: Week 52 ] Clinical response per Adapted Mayo Score. 7. Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement [ Time Frame: Week 52 ] Percentage of participants achieving histologic-endoscopic mucosal improvement. 8. Sub-Study 1: Percentage of Participants with Endoscopic Remission [ Time Frame: Week 52 ] Endoscopic remission per endoscopy subscore. 9. Sub-Study 1: Percentage of Participants with Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0 [ Time Frame: Week 52 ] Endoscopic improvement per endoscopy subscore. 10. Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC) Related Hospitalization [ Time Frame: Through Week 52 ] Parti | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed