ong Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.
- Conditions
- lcerative ColitisMedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-505699-31-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 735
Main study inclusion criteria include subjects who have not responded at the end of the induction period (Week 8) in Study M14-234 (Substudy 1), who has had lost of response during the maintenance period of Study M14-234 (Substudy 3), or who has completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for subjects with missing endoscopy at Week 8, Week 16 or Week 52 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 are met: Subjects who achieved clinical response defined by Partial Adapted Mayo Score at Week 8 of Studies M14-234 SS2 and M14-675Subjects 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., Dose Optimization Substudy Inclusion Criteria: Subject is in stable clinical remission defined as: a. SFS =1 and RBS = 0 for at least 6 consecutive months prior to randomization into the Substudy AND b. Endoscopic subscore = 0 or 1 prior to randomization into the Substudy based on central reading i. The results from the endoscopy performed within 12 weeks prior to the randomization into the Substudy can be used. If no endoscopy is available within the time frame, a colonoscopy/sigmoidoscopy is required to confirm eligibility AND c. In the 6 consecutive months prior to the randomization into the Substudy the subject has not received any new medication or increase to current concomitant medication for treatment of UC., Dose Optimization Substudy Inclusion Criteria: Subject has a fecal calprotectin level = 250 mg/kg within 4 weeks of randomization., Women of childbearing potential (refer to Section 5.2.6) must have a negative urine pregnancy test at Week 0 visit., If female, subject must meet the criteria as stated in Section 5.2.6 of this protocol: Contraception Recommendations, Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding studies., Must be able and willing to give written informed consent and to comply with the requirements of this study protocol., Dose Optimization Substudy Inclusion Criteria: Subject is currently enrolled in Main Study of M14-533 and has consented to protocol amendment 8., Dose Optimization Substudy Inclusion Criteria: Subject is currently on upadacitinib 30 mg QD and has received upadacitinib 30 mg QD for at least 6 consecutive months prior to randomization into the Substudy during maintenance and/or long-term extension period., Dose Optimization Substudy Inclusion Criteria: Subject has not been on any form of corticosteroid treatment for UC = 90 days prior to the randomization into the Substudy.
For any reason subject is considered by the investigator to be an unsuitable candidate., Current evidence of active tuberculosis; Current evidence of latent tuberculosis and for any reason the subject cannot take full course of TB prophylaxis treatment as required per protocol., 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., Subjects have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of the preceding studies., History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in the preceding studies., Laboratory values immediately prior to Week 0 of Study M14-533 meeting the toxicity management criteria for discontinuation (Section 6.1.7). Subjects with laboratory values meeting criteria for interruption may be enrolled BUT NOT dosed until guidelines for restarting study drug are met (Section 6.1.7, Table 5)., 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., Known hypersensitivity to upadacitinib or its excipients or had any AE during the preceding studies, that in the investigator's judgment makes the subject unsuitable for this study., Subject is not in compliance with prior and concomitant medication requirements and procedures throughout the preceding studies., Anticipated requirement or receipt of any live vaccine with replicating potential during study participation including up to 30 days (or longer if required locally) (8 weeks for subjects in Japan) after the last dose of study drug. Live vaccines that are incapable of replicating (e.g., JYNNEOS monkeypox vaccine) are permitted., Dose Optimization Substudy Exclusion Criteria: Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease., Dose Optimization Substudy Exclusion Criteria: Subjects who in the opinion of the investigator are likely to require surgery for UC during the substudy period., Dose Optimization Substudy Exclusion Criteria: COVID-19 infection: In subjects who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subjects health status., Enrollment in another interventional clinical study while participating in this study., 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 infect
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method