A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission

The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of \< 150.

Time frame: Week 52

Sub-Study 1: Percentage of Participants With Endoscopic Response

Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).

Time frame: Week 52

Sub-Study 3: Number of Participants With Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Time frame: Up to Week 220

Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration

Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16.

Time frame: Up to Week 16

Sub-Study 4: Percentage of Participants who had no Potential Hazards

Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16.

Time frame: Up to Week 16

Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16

SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules.

Time frame: Up to Week 16

Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16

Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score.

Time frame: Up to Week 16