Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 21 March 2022
• Main ID: EUCTR2016-000641-31-ES
• Date of registration: 14/12/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: 16/12/2016
• Target sample size: 1055
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000641-31
• 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: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Japan, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female between 18 and 75 years of age at Baseline.
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? 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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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 intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
5. 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: 19.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
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: Tablet
Route of administration of the placebo: Oral use

Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
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: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Substudy 1 and 2: Week 8.
Substudy 3: Week 44.

Main Objective: Evaluate the efficacy and safety of ABT-494 in induction and maintenance of remission in subjects with moderately to severely active ulcerative colitis

Secondary Objective: Evaluate the pharmacokinetics of ABT-494 in subjects with moderately to severely active ulcerative colitis; Characterize the dose-response, efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in subjects with moderately to severely active ulcerative colitis; Evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in subjects with moderately to severely active ulcerative colitis who had a response following induction with ABT-494.

Primary end point(s): Substudy 1 and 2: The proportion of subjects who achieve clinical remission per Adapted Mayo score at Week 8.
Substudy 3: The proportion of subjects who achieve clinical remission per Adapted Mayo score at Week 44.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Substudy 1 and 2: Week 8.
Substudy 3: Week 44.

Secondary end point(s): Substudy 1 and 2:
1. Proportion of subjects with endoscopic subscore = 1 at Week 8
2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 8
3. Proportion of subjects achieving clinical response per Adapted Mayo score at Week 8

Substudy 3:
1. Proportion of subjects with endoscopic subscore =1 at Week 44
2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 44
3. Proportion of subjects who discontinued corticosteroid use for at least 90 days and achieved clinical remission per Adapted Mayo score at Week 44

Secondary ID(s)

M14-234

2016-000641-31-SK

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 16/12/2016
Contact: