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

Phase 1

Conditions: lcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2016-000674-38-SK

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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.

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.

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the Long-Term Safety and Efficacy of ABT-494;Secondary Objective: none;Primary end point(s): Incidence of adverse events (Aes) will be assessed for both Main Study, Dose Optimization Substudy, and in an integrated manner. Changes in vital signs, physical examination results, and change from the randomization into the Dose Optimization Substudy in clinical laboratory data will be assessed. Primary endpoint for Efficacy of Dose Optimization Substudy:: Proportion of subjects with clinical remission per Adapted Mayo Score at Week 48 defined as SFS = 1 and not greater than baseline, RBS of 0, endoscopy subscore = 1 without friability, and without corticosteroid use during the 48-week period.<br>;Timepoint(s) of evaluation of this end point: Up to 288 weeks with the option of continued treatment dependent on<br>country specific regulatory approval and local requirements.<br>

Secondary Outcome Measures

Name	Time	Method
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<br>country specific regulatory approval and local requirements.<br>

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