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

Phase 1

• Conditions: lcerative 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]

• Registration Number: EUCTR2016-000674-38-BE
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 950

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.
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 and Pregnancy Testing.
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 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 or untreated latent tuberculosis.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified