A Phase 3 interventional study of Upadacitinib and Placebo for Upadacitinib in Crohn's Disease, sponsored by AbbVie. Active, not recruiting at 466 sites in 49 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Among 55 studies in Crohn Disease by AbbVie — 6 open to participants now, 14 under way, 6 of them phase 3. Crohn Disease · AbbVie.
Among the 55 studies in Crohn Disease by AbbVie, this one is the 4th largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2018, is one of 16 in phase 3, reaches primary completion later than 1 of the 13 other live ones, and was the 32nd registered.
1,992 studies on the registry are indexed under Crohn Disease; 477 are open to participants now.
Browse Crohn Disease studies →6 of the 55 studies in Crohn Disease by AbbVie are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in United States, Canada, Israel and 2 more countries
Ages 18–75
AbbVie · Sites in Italy
Ages 18+
AbbVie · Sites in Belgium
Ages 18+
AbbVie · Sites in United States, Austria, Belgium and 30 more countries
Ages 18–75
AbbVie · Sites in United States, Belgium, Bulgaria and 18 more countries
Ages 2–17
By country, each count listing its studies:
Of the 353 Crohn Disease studies recruiting now, 154 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 95 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 747 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Median enrollment 220 across the 27 interventional studies, 252 across the 26 observational. Of the 38 that completed or were terminated, 28 (74%) have results posted.
This tab as a report to print or save as PDF → With an account.
AbbVie is the lead sponsor of 976 studies on the registry; 135 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
2 of the studies in Crohn Disease by AbbVie that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06063967Phase 3AbbVieA Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. | 2027-03 |
| NCT03345823Phase 3AbbVieA Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | 2027-09 |
Add all 2 to your calendar (.ics) → With an account.
Among the 55 studies in Crohn Disease by AbbVie, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Substudy 1:
For Substudy 2:
Exclusion Criteria:
For Substudies 1 and 2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.
Drug: Upadacitinib
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.
Drug: Upadacitinib
This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.
Drug: Placebo for Upadacitinib
This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.
Drug: Placebo for Upadacitinib
This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.
Drug: Upadacitinib
This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.
Drug: Upadacitinib
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.
Drug: Upadacitinib
This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.
Drug: Upadacitinib
This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.
Drug: Placebo for Upadacitinib
Oral; Tablet
Also known as: ABT-494, RINVOQ
Oral; Tablet
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Clinical remission per CDAI is defined as CDAI \<150.
Time frame: Week 52
Sub-Study 1: Percentage of Participants with Endoscopic Response
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Time frame: Week 52
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.
Time frame: Through Week 240
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Time frame: Week 52
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Decrease of at least 100 points in CDAI from Baseline.
Time frame: Week 52
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Time frame: Week 52
Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants
This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI \<150.
Time frame: Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Clinical remission per CDAI is defined as CDAI \<150. Endoscopic remission is defined per SES-CD.
Time frame: Week 52
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Clinical remission per CDAI is defined as CDAI \<150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0).
Time frame: Through Week 52
Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.
This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Time frame: Week 52
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Time frame: Baseline (Week 0) to Week 52
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The FACIT-F questionnaire was developed to assess fatigue.
Time frame: Baseline (Week 0) to Week 52
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
This is assessed by reviewing participant's hospitalization data.
Time frame: Up to Week 52
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time frame: Week 52
Showing the first 100 of 466 sites across 49 countries. Choose a country and city above to see the rest.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing visit https://vivli.org/ ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Started Mar 2018 (actual). Primary completion is estimated for Sep 2027, 114 months after the start.
Of 70 industry-sponsored phase 3 interventional studies under Crohn Disease, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 69. This study's planned 114 months is above that.
Counting every sponsor, half of 88 studies reached it within 49 months; a quarter within 36 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upadacitinib