Upadacitinib for Crohn Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Crohn Disease+1 More
Upadacitinib - Drug
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

2 of 3
This is further along than 85% of similar trials

Other trials for Crohn Disease

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

3 of 3
This is further along than 85% of similar trials

Other trials for Crohn Disease

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
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03345849) in the Part 2: Upadacitinib 45 mg / Upadacitinib 30 mg ARM group. Side effects include: NASOPHARYNGITIS with 7%, PYREXIA with 5%, CROHN'S DISEASE with 5%, ANAEMIA with 3%, GASTROENTERITIS VIRAL with 2%.

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: Drug
Group A - Arm A
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: Drug
Group B - Arm C
Drug
Experimental Group · 1 Intervention: Placebo for Upadacitinib · Intervention Types: Drug
Group A- Arm C
Drug
Experimental Group · 1 Intervention: Placebo for Upadacitinib · Intervention Types: Drug
Group A - Arm B
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: Drug
Group B - Arm B
Drug
Experimental Group · 1 Intervention: Upadacitinib · Intervention Types: Drug
Treatment
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 preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

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.