A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
- Conditions
- Chronic colon inflammationIBD1001796910003816
- Registration Number
- NL-OMON49261
- Lead Sponsor
- AbbVie B.V.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
· 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) <= 2 × upper
limit of
normal (ULN);Total white blood cell (WBC) count >= 3.0 × 109 /L;
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for Study M15-722 is the proportion of subjects with<br /><br>endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints for Induction Period (Weeks 0 to 12)<br /><br>- Proportion of subjects with clinical remission per Adapted Mayo score at Week<br /><br>8<br /><br>- Proportion of subjects with clinical response per Adapted Mayo score at Week<br /><br>8<br /><br>- Proportion of subjects with clinical response per Partial Adapted Mayo score<br /><br>over time<br /><br>- Proportion of subjects with clinical remission per Full Mayo score at Week 8<br /><br>in subjects with a Full Mayo score of 6 to 12 at Baseline<br /><br>- Proportion of subjects with endoscopic remission at Week 8 </p><br>