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NCT06063967 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

A Phase 3 study of Crohn's Disease, sponsored by AbbVie.

Active
Registry status
Phase 3
Development phase
289
Enrollment target
20
Study locations

NCT06063967: Active Phase 3 study of Crohn's Disease, sponsored by AbbVie.

NCT06063967 is a Phase 3 study of Crohn's Disease that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 289 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06063967, a Phase 3 study of Crohn's Disease, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
289 participants
Enrollment target
20
Study locations

Study Summary

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Primary Outcome

The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150

Conditions Studied

Crohn's Disease

Interventions

  • DRUG Risankizumab SC
  • DRUG Placebo for risankizumab

Study Locations (20)

California

  • Kindred Medical Institute - Corona /ID# 262075 - Corona
  • Southern California Res. Ctr. /ID# 256612 - Coronado
  • Valley Clinical Trials, LLC dba Flourish Research /ID# 256610 - Covina
  • Newport Huntington Medical Group /ID# 256622 - Huntington Beach
  • Om Research LLC /ID# 259645 - Lancaster
  • Om Research LLC /ID# 267523 - Lancaster
  • Clinnova Research - Orange /ID# 270138 - Orange
  • University of California, Irvine Medical Center /ID# 259677 - Orange
  • Prospective Research Innovations Inc. /ID# 267856 - Rancho Cucamonga
  • University of California San Francisco - Mission Bay /ID# 267529 - San Francisco
  • Amicis Research Center - Valencia /ID# 269158 - Valencia
  • OM Research LLC /ID# 268735 - Victorville

Florida

  • Novum Research /ID# 269223 - Clermont
  • Research Associates of South Florida, LLC /ID# 261627 - Coral Gables
  • University of Florida College of Medicine /ID# 261248 - Gainesville
  • Auzmer Research /ID# 261437 - Lakeland
  • Cfagi Llc /Id# 262005 - Maitland
  • Atlantic Medical Research /ID# 256471 - Margate

Arizona

  • Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178 - Sun City

Connecticut

  • Danbury Hospital, Western Connecticut Health Network /ID# 261851 - Danbury

Trial Details

FieldValue
Enrollment Target 289 participants
Start Date 2023-11-15
Est. Completion 2027-03
Phase Phase 3
AbbVie

526 total trials

What the registry record for NCT06063967 still lists

NCT06063967 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Risankizumab SC is the first listed.

NCT06063967 names 20 study sites across 4 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT06063967 about?

NCT06063967 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.". Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effect...

What is the current status of trial NCT06063967?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 289 participants. The study started on 2023-11-15. Estimated completion is 2027-03.

What conditions does trial NCT06063967 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT06063967?

The interventions under investigation include: Risankizumab SC (DRUG), Placebo for risankizumab (DRUG).

Who is sponsoring clinical trial NCT06063967?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06063967 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Crohn's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06063967's enrollment target sits among peer trials

289 42nd of 105 higher than 64 of 105 other Crohn's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06063967, the US trial registry maintained by the National Library of Medicine. NCT06063967 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.