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Monoclonal Antibodies

Risankizumab for Crohn's Disease

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 71 days
Awards & highlights

Study Summary

This trial will investigate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD.

Eligible Conditions
  • Crohn's Disease
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 71 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 71 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC From Time 0 to Infinity (AUCinf) of Caffeine
AUC From Time 0 to Infinity (AUCinf) of Metoprolol
AUC From Time 0 to Infinity (AUCinf) of Midazolam
+27 more

Side effects data

From 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cytochrome P450 (CYP) + RisankizumabExperimental Treatment2 Interventions
In Period 1, participants will receive single oral dose of Cytochrome P450 (CYP) substrates on Day 1. In Period 2, three IV doses of risankizumab on Days 1, 29 and 57, followed by single oral dose of CYP substrates on Day 64 will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 3
~3140
Cytochrome P450 (CYP) Substrates
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
501,085 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,919 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
2020. "A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04254783.
~4 spots leftby Apr 2025
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