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

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NCT03105102 · readout ≤ 924 d

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

1,336actual

Sites

496

Countries

Argentina, Australia, Austria +44

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2018-04-09

actual

When the study began enrolling

Primary completion

Feb 2029

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Feb 2029

estimated

The whole study's end, after follow-up

First posted

2017-04-07

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Crohn's Disease

Interventions

Drug: Placebo for Risankizumab SC
Drug: Risankizumab IV — also filed as ABBV-066, BI 655066, SKYRIZI
Drug: Placebo for Risankizumab IV
Drug: Risankizumab SC — also filed as ABBV-066, BI 655066, SKYRIZI
Drug: Risankizumab On-Body Injector (OBI) — also filed as ABBV-066, BI 655066, SKYRIZI

Primary outcomes

what the primary-completion date above is the date OF

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

measured Week 52

Sub-Study 1: Percentage of Participants With Endoscopic Response

measured Week 52

Sub-Study 3: Number of Participants With Adverse Events

measured Up to Week 220

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

measured Up to Week 16

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

measured Up to Week 16

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

measured Up to Week 16

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

measured Up to Week 16

Publications

PMID 39909280 — linked by the registry
PMID 39802486 — linked by the registry
PMID 39485390 — linked by the registry
PMID 39131711 — linked by the registry
PMID 39054592 — linked by the registry
PMID 37797293 — linked by the registry
PMID 37368103 — linked by the registry
PMID 36917429 — linked by the registry
PMID 35644155 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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