Health conditions
(Data source: WHO)
Crohn's Disease (CD)
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions (Data source: WHO)
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
For Substudy 1:
- Participant who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
- Participant completes Week 12 or Week 24 study procedures in study M14-431 or study M14-433. The final endoscopy for studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
For Substudy 2:
- Participant completes Substudy 1 of Study M14-430. The week 52 endoscopy may be missing, if the endoscopy cannot be performed during the coronavirus SARS-CoV-2 pandemic.
- Participant achieved clinical response at Week 24 and completed Week 24 visit and procedures in Part 3/Cohort 3 of Study M14-431.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 710
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
Exclusion criteria:
For Sub-studies 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 Study M14-431, M14-433 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
- Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects 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 Study M14-431, M14-433, or Substudy 1 of Study M14-430 (Week 52).
-
Further information on trial
Date trial registered
Mar 8, 2018
Incorporation of the first participant
May 18, 2018
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
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
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Substudy 1 Randomized, double-blind. Substudy 2 Both open-label and double-blind If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: Substudy 1 (randomized, double-blind, placebo-controlled maintenance): To evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to upadacitinib induction treatment in Studies M14-431 or M14-433.
Substudy 2 (long-term extension [LTE]): To evaluate safety and efficacy of long-term administration of upadacitinib in subjects with moderately to severely active CD who participated in the Phase 3 upadacitinib induction and maintenance studies.;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Substudy 1, Cohort 1 (Upadacitinib vs Placebo)
Co-Primary Endpoints:
? Proportion of subjects with clinical remission per PROs at Week 52, AND
? Proportion of subjects with endoscopic response at Week 52
Substudy 2
Primary Endpoint: Incidence of AEs over time
;Timepoint(s) of evaluation of this end point: Week 52
Secundary end point
(Data source: WHO)
Secondary end point(s): Substudy 1
1. Proportion of subjects with clinical remission per CDAI at Week 52
2. Proportion of subjects with endoscopic remission at Week 52
3. Change from Baseline in IBDQ at week 52
4. Proportion of subjects achieving CR-100 at week 52
5. Proportion of subjects who discontinued corticosteroid use for CD at least 90 days prior to Week 52 and achieved clinical remission per PROs at Week 52 in subjects taking corticosteroids for CD at Baseline of induction.
6. Proportion of subjects with clinical remission per PROs at Week 0 and Week 52
7. Change from Baseline in FACIT-F at Week 52
8. Proportion of subjects with clinical remission per PROs and endoscopic remission at Week 52
9. Proportion of subjects with CD-related hospitalizations during the 52 Week double-blind maintenance period
10. Proportion of subjects with resolution of extra-intestinal manifestation (EIM) at week 52, in subjects with EIMs at Baseline.
Substudy 2
Proportion of subjects
? with clinical remission over time
? with enhanced clinical response over time
? with endoscopic remission at Week 0, and every 48 weeks thereafter
? with endoscopic response at Week 0, and every 48 weeks thereafter
? who discontinue corticosteroid use and achieve clinical remission over time among subjects taking steroids at Baseline (of induction)
? with clinical remission over time who were in clinical remission at Week 0
? achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response (increase of IBDQ = 16 over time)
Time loss of
? enhanced clinical response
? clinical remission
;Timepoint(s) of evaluation of this end point: Substudy 1
1. week 52
2. week 52
3. week 52
4. week 52
5. week 52
6. week 52
7. week 52
8. week 52
9. week 52
10. week 52
Substudy 2
Over study duration
Contact information
(Data source: WHO)
AbbVie Inc.
Trial results
(Data source: WHO)
Results summary
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
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contact for further information on the trial
Contact for general information
(Data source: WHO)
EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall Road
AbbVie Ltd
441628561090
eu-clinical-trials@abbvie.com
Contact for scientific information
(Data source: WHO)
EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall Road
AbbVie Ltd
441628561090
eu-clinical-trials@abbvie.com
Further trial identification numbers
Secondary ID (Data source: WHO)
M14-430
2017-001225-41-SK
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