Clinical Trials Logo

Clinical Trial Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03398148
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 7, 2018
Completion date May 11, 2023

See also
  Status Clinical Trial Phase
Completed NCT02819635 - A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC) Phase 2/Phase 3
Completed NCT02345733 - Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis Phase 4
Terminated NCT02217722 - Use of the Ulcerative Colitis Diet for Induction of Remission N/A
Completed NCT02778464 - Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
Completed NCT01971814 - Early Serum Infliximab Levels in Severe Ulcerative Colitis. Phase 1
Completed NCT03223012 - Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
Active, not recruiting NCT03456206 - Chronic Inflammatory Disease, Lifestyle and Risk of Disease
Completed NCT04254783 - 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 Phase 1
Withdrawn NCT02087878 - A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma
Completed NCT02065622 - Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis Phase 3
Completed NCT03695185 - A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Phase 2
Completed NCT02108821 - Fecal Microbiota Transplantation in Pediatric Patients Phase 1
Terminated NCT03758443 - Efficacy & Safety of TD-1473 in Ulcerative Colitis Phase 2/Phase 3
Completed NCT01364896 - Anal Human Papillomavirus in Inflammatory Bowel Disease Study
Terminated NCT03920254 - TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study Phase 2/Phase 3
Recruiting NCT01277419 - German Spondyloarthritis Inception Cohort
Recruiting NCT05377580 - A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis Phase 2
Recruiting NCT03609905 - Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis Phase 1/Phase 2
Active, not recruiting NCT03006068 - A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) Phase 3
Recruiting NCT05414578 - NORDTREAT Prospective Study on Inflammatory Bowel Disease