A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
- Conditions
- MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856lcerative ColitisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-000930-37-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
·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) < o = 2 × upper limit of normal (ULN);Total white blood cell (WBC) count > o = 3.0 × 10^9 /L;
Confirmed COVID-19: the Baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic subjects must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms;
Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure.
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 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
- 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
- Confirmed COVID-19: the Baseline visit must be at least 14 days from onset of signs/symptoms or positive SARS-CoV-2 test; symptomatic subjects must have recovered, defined as resolution of fever without use of antipyretics and improvement in symptoms;
- Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 14 days from a potential exposure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the efficacy, safety, and tolerability of Ravagalimab (ABBV-323) as induction treatment in subjects with moderately to severely active UC.;Secondary Objective: 1. To assess pharmacokinetics (PK) and receptor occupancy (RO) of ABBV-323 in subjects with moderately to severely active UC.<br>2. To characterize the efficacy, safety, and tolerability of ABBV-323 as maintenance therapy in subjects with clinical response to ABBV-323 following induction therapy.;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: At week 8
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Time points provided in E.5.2;Secondary end point(s): Secondary Endpoints (Weeks 0 to 12):<br>- Proportion of subjects with clinical remission per Adapted Mayo score at Week 8<br>- Proportion of subjects with clinical response per Adapted Mayo score at Week 8<br>- Proportion of subjects with clinical response per Partial Adapted Mayo score over time<br>- 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.<br>- Proportion of subjects with endoscopic remission at Week 8