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

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-000930-37-NL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified