Upadacitinib for Crohn Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Crohn Disease+1 More
Upadacitinib - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing a new Crohn's disease drug to see if it is effective and safe.
Eligible Conditions
- Crohn Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
3 Primary · 12 Secondary · Reporting Duration: Through Week 240
Week 52
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Through Week 240
Sub-Study 2: Number of Participants with Adverse Events
Through Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Up to Week 52
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
Week 52
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Adrenal Cortex Hormones
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Sub-Study 1: Percentage of Participants with Endoscopic Response
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
Eye Manifestations
Adrenal Cortex Hormones
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Part 2: Upadacitinib 45 mg / Upadacitinib 30 mg
7%NASOPHARYNGITIS
5%PYREXIA
5%CROHN'S DISEASE
3%ANAEMIA
2%GASTROENTERITIS VIRAL
2%ENTERITIS
2%COVID-19
2%ACUTE KIDNEY INJURY
2%UPPER RESPIRATORY TRACT INFECTION
2%ARTHRALGIA
2%RASH
2%INTESTINAL OBSTRUCTION
2%ACNE
Trial Design
6 Treatment Groups
Group B - Arm A
1 of 6
Group A - Arm A
1 of 6
Group B - Arm C
1 of 6
Group A- Arm C
1 of 6
Group A - Arm B
1 of 6
Group B - Arm B
1 of 6
Experimental Treatment
903 Total Participants · 6 Treatment Groups
Primary Treatment: Upadacitinib · Has Placebo Group · Phase 3
Group B - Arm A
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: DrugGroup A - Arm A
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: DrugGroup B - Arm C
Drug
Experimental Group · 1 Intervention: Placebo for Upadacitinib · Intervention Types: DrugGroup A- Arm C
Drug
Experimental Group · 1 Intervention: Placebo for Upadacitinib · Intervention Types: DrugGroup A - Arm B
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: DrugGroup B - Arm B
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo for Upadacitinib
2017
Completed Phase 3
~530
Upadacitinib
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through week 240
Who is running the clinical trial?
AbbVieLead Sponsor
822 Previous Clinical Trials
468,702 Total Patients Enrolled
40 Trials studying Crohn Disease
13,779 Patients Enrolled for Crohn Disease
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,192 Total Patients Enrolled
13 Trials studying Crohn Disease
2,596 Patients Enrolled for Crohn Disease
ABBVIE INC.Study DirectorAbbVie
295 Previous Clinical Trials
116,246 Total Patients Enrolled
11 Trials studying Crohn Disease
6,755 Patients Enrolled for Crohn Disease
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:A participant who experiences a clinical response at the time described in the protocol and completes all study procedures in the parent study/ substudy.
The participant in the parent study completed all the procedures
People who responded to treatment in either of the two studies mentioned.
If the endoscopy cannot be done during the pandemic, it may be missing from the Week 52 results.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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