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: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: [ABT-494]
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool
frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic
Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a
central reader.
- Demonstrated an inadequate response or intolerance to one or more
conventional and/or biologic therapies, in the opinion of the
investigator, as defined below:
Oral locally acting steroids
Intravenous or oral corticosteroids
Immunosuppressants
Biologic therapies for CD
Note: Non-bio-IR subjects who have received prior biologic for up to 1
year but have not failed may be enrolled; however, participants must
have discontinued the biologic for reasons other than inadequate
response or intolerance (e.g., change of insurance, well controlled
disease),
- If female, subject must meet the contraception recommendations.
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 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
Exclusion criteria:
-Subject with a current diagnosis of ulcerative colitis or indeterminate
colitis.
- Subject not on stable doses of CD related antibiotics, oral
aminosalicylates, corticosteroids or methotrexate (MTX).
- Subject with the following known complications of CD: abscess
(abdominal or peri-anal), > 2 entire missing segments of the following 5
segments: terminal ileum, right colon, transverse
colon, sigmoid and left colon, and rectum, symptomatic bowel strictures,
fulminant colitis, toxic megacolon, or any other manifestation that might
require surgery while enrolled in the study.
- Subject with ostomy or ileoanal pouch
- Subject diagnosed with short gut or short bowel syndrome
- Screening laboratory and other analyses show abnormal results.
-
Further information on trial
Date trial registered
Jun 15, 2021
Incorporation of the first participant
Apr 12, 2018
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies. - na
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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Co-primary Endpoints:
1. Proportion of subjects with clinical remission per PROs at Week 12, and
2. Proportion of subjects with endoscopic response at Week 12.;Timepoint(s) of evaluation of this end point: Week 12
Secundary end point
(Data source: WHO)
Secondary end point(s): 1. Proportion of subjects with clinical remission per CDAI (CDAI < 150)
2. Proportion of subjects with clinical remission at Week 4
3. Proportion of subjects with endoscopic remission at Week 12
4. Proportion of subjects who discontinue corticosteroid use for CD and
achieve clinical remission at Week 12, in subjects taking corticosteroids
for CD at Baseline
5. Change from Baseline in FACIT-F at Week 12
6. Change from Baseline in IBDQ at Week 12
7. Proportion of subjects achieving CR-100 at Week 2
8. Proportion of subjects achieving CR-100 at Week 12
9. Proportion of subjects with hospitalizations due to CD during the 12
week double-blind induction period
10. Proportion of subjects with resolution of extra-intestinal
manifestation (EIM) at week 12, in subjects with EIM at Baseline;Timepoint(s) of evaluation of this end point: 1. week 12
2. week 4
3. week 12
4. week 12
5. week 12
6. week 12
7. week 2
8. week 12
9. week 12
10. week 12
Contact information
(Data source: WHO)
AbbVie Inc.
Trial results
(Data source: WHO)
Results summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies
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, Denmark, Egypt, Estonia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, 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
441628461153
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
441628461153
eu-clinical-trials@abbvie.com
Further trial identification numbers
Secondary ID (Data source: WHO)
M14-433
2017-001240-35-SK
Back to overview
