Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.

• Register: EUCTR
• Last refreshed on: 27 January 2025
• Main ID: EUCTR2016-000674-38-LV
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.
• Scientific title: A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)
• Date of first enrolment: 22/11/2016
• Target sample size: 950
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000674-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• 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, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, European Union, Finland, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, 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. Subject has not responded at the end of the induction period (Week 8) in Study M14-234 (Substudies 1 and 2), who has been an inadequate responder during the maintenance period of Study M14-234 (Substudy 3), or who has responded and successfully completed Study M14-234.
2. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations and Pregnancy Testing.
3. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug.
4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
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 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
1. For any reason subject is considered by the investigator to be an unsuitable candidate.
2. Female subject with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study.
3. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.


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: 15-

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-

Primary Outcome(s)

Secondary Objective: none

Primary end point(s): The clinical remission or response will be evaluated using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted Mayo score (Full Mayo score excluding Physician’s Global Assessment), or Partial Mayo score (Full Mayo score excluding endoscopic subscore).

Timepoint(s) of evaluation of this end point: 288 weeks

Main Objective: To evaluate the Long-Term Safety and Efficacy of ABT-494

Secondary Outcome(s)

Secondary end point(s): 1. Proportion of subjects achieving clinical remission per Adapted Mayo
score (defined as SFS = 1, RBS of 0, and endoscopy subscore = 1)
2. Proportion of subjects in clinical remission per Adapted Mayo score at
Week 0 who maintain remission at Week 48.
3. Proportion of subjects achieving clinical remission per Full Mayo score
(defined as a Full Mayo score = 2 with no subscore > 1)
4. Proportion of subjects in clinical remission per full Mayo score
(defined as a Full Mayo score = 2 with no subscore > 1) at Week 0 who
maintain remission at week 48.
5. Proportion of subjects achieving clinical response per Adapted Mayo
score (defined as decrease from Baseline in the Adapted Mayo score = 2
points and = 30% from Baseline, PLUS a decrease in RBS = 1 or an
absolute RBS = 1)

Timepoint(s) of evaluation of this end point: 1. Week 0, Week 48, and every 48 weeks thereafter
2. Week 48, and every 48 weeks thereafter
3. Week 0, Week 48, and every 48 weeks thereafter
4. Week 48, and every 48 weeks thereafter
5. Week 0, Week 48, and every 48 weeks thereafter

Secondary ID(s)

M14-533

2016-000674-38-SK

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 26/10/2016
Contact: