EUCTR2018-000930-37-ESActive, not recruitingPhase 1
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •·Subjects must voluntarily sign and date an informed consent, approved
- •by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- •·Adult male or female, between 18 and 75 years of age, inclusive, at time of the Baseline visit.
- •·Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC or 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).
- •·History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).
- •·Laboratory values that meet the following criteria:
- •- Serum aspartate transaminase (AST) and alanine transaminase (ALT) = 2 × upper limit of
- •normal (ULN);Total white blood cell (WBC) count = 3.0 × 10^9 /L;
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •- Subject must not have an active, chronic, or recurrent infection that based on the
- •Investigator's clinical assessment makes the subject an unsuitable candidate for the study
- •- Subject must not have any malignancy except for successfully treated non metastatic cutaneous
- •squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- •- Subject must not have history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy
- •performed during the Screening endoscopy
Investigators
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