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

AbbVie42 enrolled

Overview

Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis (UC)

Interventions

Ravagalimab 600 mgDRUG

Ravagalimab 600 mg was administered intravenously (IV).

Ravagalimab 300 mgDRUG

Ravagalimab 300 mg was administered subcutaneously (SC).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

Percentage of Participants With Endoscopic Improvement During Induction Period

Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.

Time frame: At Week 8

Secondary Outcomes

Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period

Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) \<=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore \<=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore confirmed by central reader, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.

Time frame: At Week 8

Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period

Clinical response per Adapted Mayo score is defined as the decrease from Baseline \>= 2 points and \>= 30%, PLUS a decrease in RBS \>=1 or an absolute RBS \<=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.

Data from ClinicalTrials.gov

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Banner University Medical Cent /ID# 208392

Tucson, Arizona, United States

Meridian Investigator Network /ID# 204646

Huntington Beach, California, United States

Meridian Investigator Network /ID# 218568

Lakewood, California, United States

TLC Clinical Research Inc /ID# 206626

Los Angeles, California, United States

Orange County Institute of Gastroenterology and Endoscopy /ID# 207405

Mission Viejo, California, United States

UC Davis Medical Center /ID# 209402

Sacramento, California, United States

The University of Chicago DCAM /ID# 207086

Chicago, Illinois, United States

Affinity Clinical Research /ID# 206211

Oak Brook, Illinois, United States

Univ New Mexico /ID# 208817

Albuquerque, New Mexico, United States

Penn Presbyterian Medical Center /ID# 206826

Philadelphia, Pennsylvania, United States

...and 24 more locations