|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Medical condition in easily understood language
|A long-term (chronic) condition where the colon and rectum (large intestine or large bowel) become inflamed.
|Diseases [C] - Digestive System Diseases [C06]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|To explore the efficacy, safety, and tolerability of Ravagalimab (ABBV-323) as treatment in subjects with moderately to severely active UC.
|Secondary objectives of the trial
|Trial contains a sub-study
|Principal 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;
|Principal 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
|E.5 End points
|Primary end point(s)
|The proportion of subjects with endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8.
|Timepoint(s) of evaluation of this end point
|Secondary end point(s)
|Secondary Endpoints (Weeks 0 to 12):
- Proportion of subjects with clinical remission per Adapted Mayo score at Week 8
- Proportion of subjects with clinical response per Adapted Mayo score at Week 8
- Proportion of subjects with clinical response per Partial Adapted Mayo score over time
- Proportion of subjects with clinical remission per Full Mayo score at Week 8 in subjects with a Full Mayo score of 6 to 12 at Baseline.
- Proportion of subjects with endoscopic remission at Week 8
|Timepoint(s) of evaluation of this end point
|Time points provided in E.5.2
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|84 days after the last subject last dose of study drug
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial months
|In all countries concerned by the trial days