A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Official Title
-----------------
A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

Conditions
-----------------
Crohn's Disease (CD)

Intervention / Treatment
-----------------
* Drug: ABT-494


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must have completed Study M13-740 through Week 52. If female, participant must be postmenopausal, surgically sterile or on using a birth control method. Exclusion Criteria: For any reason participant is considered by the investigator to be an unsuitable candidate Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upadacitinib (ABT-494) Dose A<br>Open label dose A once daily (QD) | Drug: ABT-494<br>* Tablet: Oral<br>* Other names: RINVOQ;|
| Experimental: Upadacitinib (ABT-494) Dose B<br>Open label dose B QD | Drug: ABT-494<br>* Tablet: Oral<br>* Other names: RINVOQ;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Remission | It is defined as the percentage of participants achieving clinical remission and endoscopic remission. | Up to Month 96 | 
| Percentage of Participants in Remission at Week 0 Who Maintain Remission | Remission is defined as participants achieving clinical remission and endoscopic remission. | Up to Month 96 | 
| Percentage of Participants Achieving Response | It is defined as the percentage of participants achieving clinical response and endoscopic response. | Up to Month 96 | 
| Percentage of Participants Achieving Clinical Remission | Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 | 
| Percentage of Participants Achieving Modified Clinical Remission | Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 | 
| Percentage of Participants Achieving Enhanced Clinical Response | Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 | 
| Percentage of Participants Achieving Clinical Response | Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 | 
| Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 | 
| Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission | Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 | 
| Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission. | Up to Month 96 | 
| Percentage of Participants Achieving Endoscopic Response | Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 | 
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission | It is defined as CDAI less than 150. | Up to Month 96 | 
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response | CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740. | Up to Month 96 | 
| Percentage of Participants Achieving Enhanced CDAI Response | Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740. | Up to Month 96 | 
| Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission | IBDQ remission is defined as IBDQ >= 170. | Up to Month 96 | 
| Percentage of Participants Achieving IBDQ Response | IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740. | Up to Month 96 | 
| Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free | Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free | Up to Month 96 | 
| Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission | Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission | Up to Month 96 | 
| Percentage of Participants Achieving Remission and Normal C-Reactive Protein | Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission. | Up to Month 96 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Efficacy, Safety, Tolerability, ABT-494