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

• Register: EUCTR
• Last refreshed on: 18 March 2024
• Main ID: EUCTR2016-000674-38-GR
• Date of registration: 03/10/2016
• 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, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)
• Date of first enrolment: 21/12/2016
• 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: yes Randomised: yes Open: yes 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: 4
• 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, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, 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 (Substudy 1), 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 substudy 3.

During the COVID-19 pandemic, for subjects with missing endoscopy due to the COVID-19 pandemic in studies M14-234 SS2, SS3 and M14-675 those following subjects may be enrolled if the below criteria is met:
Subjects who achieved clinical response defined by Partial Adapted Mayo Score at Week 8 of Studies M14-234 SS2 and M14-675
? Subjects who achieved clinical response defined by Partial Adapted Mayo Score at Week 16 in the extended treatment period of Studies M14-234 SS2 and M14-675
Note: If endoscopy is missing at Week 8 but can be performed at Week 16, Week 16 endoscopy should be performed. However, the status of clinical response will be defined by Partial Adapted Mayo Score and clinical responders may enter Study M14-533 Cohort 1.
? Subjects who have completed the 52-week treatment in Study M14-234 SS3 if the PI considers it is safe to continue based on phone/video call, subject's medical history and findings from the last endoscopy.

2. Women of childbearing potential (refer to Section 5.2.4) must have a negative urine pregnancy test at Week 0 visit.

3. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations

4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding studies.

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 891
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

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 the preceding studies) or who is considering becoming pregnant during the study and within 30 days after the last dose of study drug.

3. Subject with an active or recurrent infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.

4. Current evidence of active tuberculosis; Current evidence of latent tuberculosis and for any reason the subject cannot take full course of TB prophylaxis treatment

5. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), 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

Ulcerative Colitis
MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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: 15-
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: ABT-494
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

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: 7.5-
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: Up to 288 weeks with the option of continued treatment dependent on
country specific regulatory approval and local requirements.

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

Primary end point(s): The primary endpoint of the study is to evaluate the long-term safety and tolerability of upadacitinib through the assessment of the incidence of treatment-emergent adverse events, changes in vital signs, physical examination results, and clinical laboratory data.

Secondary Objective: none

Secondary Outcome(s)

Secondary 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: Up to 288 weeks with the option of continued treatment dependent on
country specific regulatory approval and local requirements.

Secondary ID(s)

2016-000674-38-SK

M14-533

Source(s) of Monetary Support

AbbVie Inc.

Ethics review

Status: Approved
Approval date: 21/12/2016
Contact: