Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

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NCT04524611 · readout ≤ 559 d

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

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Single · Treatment

Enrollment

527actual

Sites

300

Countries

Argentina, Australia, Austria +28

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

2020-09-30

actual

When the study began enrolling

Primary completion

Feb 2028

estimated

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

Study completion

Feb 2028

estimated

The whole study's end, after follow-up

First posted

2020-08-24

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-04-13

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 (CD)

Interventions

Drug: Risankizumab — also filed as ABBV-066, SKYRIZI
Drug: Risankizumab — also filed as ABBV-066, SKYRIZI
Drug: Ustekinumab
Drug: Ustekinumab

Primary outcomes

what the primary-completion date above is the date OF

Percentage of Participants Achieving Clinical Remission at Week 24

measured Week 24

Percentage of Participants Achieving Endoscopic Remission

measured Week 48

Number of Participants Reporting Adverse Events

measured Up to 220 Weeks

Publications

PMID 42479626 — linked by the registry
PMID 41344313 — linked by the registry
PMID 40357993 — linked by the registry
PMID 39018531 — 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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