A single-arm, open-label study to evaluate the efficacy and safety of ABBV-668 in subjectswith moderate to severe ulcerative colitis
- Conditions
- lcerative ColitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856
- Registration Number
- CTIS2022-501263-41-00
- Lead Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Adult male or female, at least 18 years old at time of the Baseline visit., Diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available., Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review)., Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.
Anything other than a positive response to the questions in section 5.1 Eligibility Criteria of the Protocol will result in exclusion from study participation.
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