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EUCTR2017-001240-35

A 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

Data source: WHO (Imported from 02.08.2020)
Changed: 02.08.2020
Disease category:

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: 45-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Inclusion/Exclusion Criteria (Data source: WHO)

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 the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001240-35

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2017-001240-35-HU

Further information on trial

Date trial registered

07.03.2018

Incorporation of the first participant

18.05.2018

Recruitment status

Authorised-recruitment may be ongoing or finished

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

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

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, Denmark, Egypt, Estonia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Republic of, 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

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

AbbVie Deutschland GmbH & Co. KG

Further trial identification numbers

Secondary ID (Data source: WHO)

M14-433
2017-001240-35-SK