A Phase 3 interventional study of Placebo for Risankizumab SC and Risankizumab IV in Crohn's Disease, sponsored by AbbVie. Active, not recruiting at 496 sites in 47 countries. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The study consists of 4 sub-studies, as follows:
Sub-Study 4:
Exclusion Criteria:
Participants randomized to receive double-blind placebo for risankizumab for 52 weeks.
Drug: Placebo for Risankizumab SC
Participants randomized to receive double-blind risankizumab dose 1 for 52 weeks.
Drug: Risankizumab SC
Participants randomized to receive double-blind risankizumab dose 2 for 52 weeks.
Drug: Risankizumab SC
Participants will receive double-blind subcutaneous (SC)risankizumab dose 1 and intravenous placebo at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Drug: Placebo for Risankizumab IV · Drug: Risankizumab SC
Participants will receive double-blind subcutaneous placebo and intravenous risankizumab dose 3 at Week 0 followed by open-label SC risankizumab dose 1 from Week 8 through Week 52.
Drug: Placebo for Risankizumab SC · Drug: Risankizumab IV · Drug: Risankizumab SC
Participants who completed Sub-study 1 or Sub-study 2 or other AbbVie risankizumab Crohn's disease study or M16-006 or M15-991 without endoscopy will receive open-label risankizumab dose 1 or dose 2 depending on their preceding study beginning at Week 56.
Drug: Risankizumab SC
Participants in Sub-study 3 who meet eligible criteria for Sub-study 4 will receive risankizumab dose 1 or dose 2 via on-body injectors on Weeks 0,8 and 16. Beginning Week 24, participants will receive risankizumab dose 1 or dose 2 via pre-filled syringes Q8W.
Drug: Risankizumab SC · Drug: Risankizumab On-Body Injector (OBI)
Participants who tolerate and derive benefit from receiving risankizumab and complete Sub-study 3 or Sub-study 4 will receive risankizumab dose 1 or dose 2 Q8W.
Drug: Risankizumab SC
Placebo for Risankizumab SC Subcutaneous (SC) Injection
Risankizumab IV Intravenous (IV) infusion
Also known as: ABBV-066, BI 655066, SKYRIZI
Placebo for Risankizumab IV Intravenous (IV) infusion
Risankizumab SC Subcutaneous (SC) injection
Also known as: ABBV-066, BI 655066, SKYRIZI
Subcutaneous (SC) injection; on-body injector (OBI)
Also known as: ABBV-066, BI 655066, SKYRIZI
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
Sub-Study 1: Percentage of Participants With Clinical Remission
Clinical remission per average daily stool frequency (SF) and average daily AP score.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0
The CDAI is used to evaluate disease activity in patients with Crohn's disease
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy
Endoscopic healing was assessed using SES-CD.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Endoscopic Remission
Endoscopic Remission is defined as SES-CD \<= 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, as scored by a central reviewer
Time frame: Week 52
Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Time frame: Week 52
Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline
Participants who discontinued corticosteroid use and achieved clinical remission per average daily SF and average daily AP score.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
The CDAI is used to evaluate disease activity in patients with Crohn's disease.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission
SF Remission is defined by an average daily SF \<= 2.8 and not worse than baseline.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission
AP Remission is defined by an average daily AP \<= 1 and not worse than baseline.
Time frame: Week 52
Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response
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. Endoscopic response defined as decrease from baseline of \> 50% of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Deep Remission
Deep remission defined as participants with both clinical remission (per average daily SF and average daily AP score) and endoscopic remission (assessed using SES-CD).
Time frame: Week 52
Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Participants with an event that results in admission to the hospital.
Time frame: Up to Week 52
Sub-Study 2: 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 2: 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 2: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Participants with an event that results in admission to the hospital.
Time frame: Up to Week 52
Showing the first 100 of 496 sites across 47 countries.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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