A 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

Brief Summary
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.
Brief Title
A 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
Completion Date
Completion Date Type
Estimated
Conditions
Crohn's Disease
Eligibility Criteria
Inclusion Criteria:

For Substudy 1:

* Participant who achieve clinical response in Study M14-431 or Study M14-433.
* Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

* Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
* Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion Criteria:

For Substudies 1 and 2:

* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
* Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
* Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
Inclusion Criteria
Inclusion Criteria:

For Substudy 1:

* Participant who achieve clinical response in Study M14-431 or Study M14-433.
* Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

* Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
* Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Gender
All
Gender Based
false
Keywords
Upadacitinib
ABT-494
Extension Study
Efficacy
Safety
Crohn's Disease
Maintenance Study
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT03345823
Org Class
Industry
Org Full Name
AbbVie
Org Study Id
M14-430
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Primary Outcomes
Outcome Description
Clinical remission per CDAI is defined as CDAI \<150.
Outcome Measure
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Outcome Time Frame
Week 52
Outcome Description
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.
Outcome Measure
Sub-Study 1: Percentage of Participants with Endoscopic Response
Outcome Time Frame
Week 52
Outcome Description
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.
Outcome Measure
Number of Participants with Adverse Events
Outcome Time Frame
Through Week 240
Secondary Ids
Secondary Id
2023-504951-29
Secondary Outcomes
Outcome Description
Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Outcome Description
Decrease of at least 100 points in CDAI from Baseline.
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Outcome Description
Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Outcome Description
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.
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants
Outcome Description
Clinical remission per CDAI is defined as CDAI \<150. Endoscopic remission is defined per SES-CD.
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Outcome Description
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).
Outcome Time Frame
Through Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Outcome Description
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.
Outcome Time Frame
Week 52
Outcome Measure
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.
Outcome Description
The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
Outcome Time Frame
Baseline (Week 0) to Week 52
Outcome Measure
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Outcome Description
The FACIT-F questionnaire was developed to assess fatigue.
Outcome Time Frame
Baseline (Week 0) to Week 52
Outcome Measure
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Outcome Description
This is assessed by reviewing participant's hospitalization data.
Outcome Time Frame
Up to Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
Outcome Description
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.
Outcome Time Frame
Week 52
Outcome Measure
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joann Kwah
Investigator Email
jokwah@montefiore.org
Investigator Phone
917-885-2890 / 866-633-8255