Chronic colon inflammation IBD
Conditions
Interventions
Participants administered with ravagalimab (ABBV-323) dose A IV and ravagalimab
(ABBV-323) dose B for 12 Weeks. Participants who achieve clinical response may
enter the maintenance period in which p
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 meeting the following criteria: Serum aspartate transaminase (AST) and alanine transaminase (ALT) = 3.0 × 109 /L;
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for Study M15-722 is the proportion of subjects with endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints for Induction Period (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 | — |
Countries
Netherlands
Outcome results
None listed