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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 July 2021
Main ID:  EUCTR2016-000642-62-DE
Date of registration: 18/10/2018
Prospective Registration: Yes
Primary sponsor: AbbVie Deutschland GmbH & Co. KG
Public title: A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis
Scientific title: M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis
Date of first enrolment: 04/11/2019
Target sample size: 522
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000642-62
Study type:  Interventional clinical trial of medicinal product
Study design:  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:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belarus Bosnia and Herzegovina Brazil Canada Chile
China Colombia Croatia Czech Republic Finland France Germany Greece
Hungary Ireland Israel Italy Japan Korea, Republic of Latvia Lithuania
Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Russian Federation
Serbia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan
Turkey Ukraine United Kingdom United States
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female between 16 and 75 years of age at Baseline.
- Adolescent subjects at the age of 16 and 17 years old will be enrolled if approved by the country or regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled.
- Adolescent subjects at the age of 16 and 17 years old must weigh = 40 kg and meet the definition of Tanner Stage 5 refer to Appendix J) at the screening Visit.
2. Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy
3. Moderately to severely active ulcerative colitis
4. Demonstrated an inadequate response to, loss of response to, or intolerance to immunosuppressants, corticosteroids or biologic therapies
5. Negative pregnancy test for female subjects of childbearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range: 9
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 464
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion criteria:
1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
2. Current diagnosis of fulminant colitis and/or toxic megacolon.
3. Subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
4. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
5. Subject who received azathioprine or 6-mercaptopurine within 10 days of Baseline.
6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
7. Subject with previous exposure to JAK inhibitor.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Current Sponsor code: ABT-494
Other descriptive name: ABT-494
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

Primary Outcome(s)
Primary end point(s): The primary endpoint for Study M14-675 is the proportion of subjects who achieve clinical remission per Adapted Mayo score (defined as SFS = 1 and not greater than baseline, RBS of 0, and endoscopic sub score = 1) at Week 8.
Main Objective: The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely active ulcerative colitis.
Secondary Objective: The secondary objectives of the study are to evaluate the efficacy of upadacitinib 45 mg QD comparing with placebo in ranked secondary endpoints of achieving endoscopic improvement, endoscopic remission, clinical response per Adapted Mayo Score, clinical response per Partial Adapted Mayo score, histologic-endoscopic mucosal improvement, no bowel urgency, no abdominal pain, histologic mprovement, mucosal healing, and change in IBDQ total core and FACIT-F score.
Timepoint(s) of evaluation of this end point: Part 1: Week 8 and Part 2: Week 16 (Extended Treatment Period; as applicable)
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: For points 1,2,3,5,6,7,8,9,10,11 - week 8
For point 4 - Week 2
Secondary end point(s): 1. Proportion of subjects with endoscopic improvement at Week 8
2. Proportion of subjects with endoscopic remission at Week 8
3. Proportion of subjects achieving clinical response per Adapted Mayo Score at Week 8
4. Proportion of subjects achieving clinical response per Partial Adapted Mayo score (defined as decrease from Baseline = 1 points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an absolute RBS = 1 ) at
Week 2
5. Proportion of subjects achieving histologic-endoscopic muscosal
improvement at Week 8
6. Proportion of subjects who reported no bowel urgency at Week 8
7. Proportion of subjects who reported no abdominal pain at Week 8
8. Proportion of subjects who achieved histologic improvement at Week
8
9. Change from Baseline in IBDQ total score at Week 8
10. Proportion of subjects with mucosal healing at Week 8
11. Change from Baseline in FACIT-F score at Week 8
Secondary ID(s)
2016-000642-62-NL
M14-675
Source(s) of Monetary Support
AbbVie Inc
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 04/11/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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