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EUCTR2016-000674-38

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

Data source: WHO (Imported from 18.10.2020)
Changed: 18.10.2020
Disease category:

Health conditions (Data source: WHO)

Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem 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: 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

Inclusion/Exclusion Criteria (Data source: WHO)

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 coronavirus SARS-CoV-2 pandemic, for subjects with missing endoscopy due to the coronavirus SARS-CoV-2 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? yes
Number of subjects for this age range: 19
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.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000674-38

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2016-000674-38-GB

Further information on trial

Date trial registered

28.09.2016

Incorporation of the first participant

25.11.2016

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

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 (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: To evaluate the Long-Term Safety and Efficacy of ABT-494;Secondary Objective: none;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.;Timepoint(s) of evaluation of this end point: 288 weeks

Secundary end point (Data source: WHO)

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: 288 weeks

Contact information (Data source: WHO)

AbbVie Inc.

Trial results (Data source: WHO)

Results summary

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC)

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, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, European Union, Finland, Germany, Greece, Hungary, Ireland, Israel, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Republic of, Russian Federation, Serbia, Singapore, Slovakia, 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)

M14-533
2016-000674-38-SK