A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT03695185
• Date of registration: 02/10/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
• Scientific title: 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
• Date of first enrolment: March 26, 2019
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03695185
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants 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.

- Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of
biopsy results consistent with the diagnosis of UC in the assessment of the
Investigator, must be available.

- Participant 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).

Exclusion Criteria:

- Participant having an active, chronic, or recurrent infection that based on
Investigator's clinical assessment makes the participant an unsuitable candidate for
the study.

- Participant having any malignancy except for successfully treated non-metastatic
cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the
cervix.

- Participant with history of dysplasia of the gastrointestinal tract or evidence of
dysplasia in any biopsy performed during the screening endoscopy other than completely
removed low-grade dysplastic lesions.

- Laboratory values not 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*10^9/L.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis (UC)

Intervention(s)

Drug: ABBV-323 Dose A

Drug: ABBV-323 Dose B

Primary Outcome(s)

Percentage of Participants with Endoscopic Improvement [Time Frame: At Week 8]

Secondary Outcome(s)

Percentage of Participants with Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline [Time Frame: At Week 8]

Percentage of Participants with Clinical Response per Adapted Mayo Score [Time Frame: At Week 8]

Percentage of Participants with Clinical Response per Partial Adapted Mayo Score [Time Frame: Up to Week 12]

Percentage of Participants with Endoscopic Remission [Time Frame: At Week 8]

Percentage of Participants with Clinical Remission per Adapted Mayo Score [Time Frame: At Week 8]

Secondary ID(s)

2018-000930-37

M15-722

Source(s) of Monetary Support

Please refer to primary and secondary sponsors