Upadacitinib Maintenance Therapy for Crohn's Disease
(U-ENDURE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Upadacitinib for Crohn's Disease?
Research shows that Upadacitinib, a drug used for other conditions like rheumatoid arthritis and ulcerative colitis, has been effective in increasing clinical remission in Crohn's Disease patients over 12 and 52 weeks. Additionally, it has shown positive results in long-term studies and real-world settings, with a good balance between benefits and risks.12345
What makes the drug Upadacitinib unique for treating Crohn's Disease?
Upadacitinib is unique because it is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, offering a different mechanism of action compared to traditional treatments for Crohn's Disease that often focus on suppressing the immune system more broadly.678910
What is the purpose of this trial?
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adults with Crohn's Disease who showed improvement in previous studies (M14-431 or M14-433) and completed certain study procedures. Participants can still join if their final endoscopy was missed due to COVID-19.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Maintenance Treatment
Participants receive upadacitinib or placebo for maintenance treatment
Long-term Extension
Participants who complete the maintenance phase receive long-term treatment with upadacitinib or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Upadacitinib
Upadacitinib is already approved in European Union, United States, Canada for the following indications:
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
- Ulcerative colitis
- Crohn's disease
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
- Ulcerative colitis
- Crohn's disease
- Rheumatoid arthritis
- Psoriatic arthritis
- Atopic dermatitis
- Ankylosing spondylitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois