Back to resultsA 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
Primary Purpose
Ulcerative Colitis (UC)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ravagalimab 600 mg
Ravagalimab 300 mg
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring Ulcerative Colitis (UC), ABBV-323, Ravagalimab
Eligibility 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.
Sites / Locations
- Banner University Medical Cent /ID# 208392
- Meridian Investigator Network /ID# 204646
- Meridian Investigator Network /ID# 218568
- TLC Clinical Research Inc /ID# 206626
- Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
- UC Davis Medical Center /ID# 209402
- The University of Chicago DCAM /ID# 207086
- Affinity Clinical Research /ID# 206211
- Univ New Mexico /ID# 208817
- Penn Presbyterian Medical Center /ID# 206826
- Vanderbilt University Medical Center /ID# 204670
- Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
- Mount Sinai Hospital /ID# 206180
- Chu de Nice-Hopital L'Archet Ii /Id# 208131
- Hopital Beaujon /ID# 208129
- CHRU Nancy - Hôpitaux de Brabois /ID# 208133
- Universitaetsklinikum Frankfurt /ID# 207569
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
- Debreceni Egyetem Klinikai Kozpont /ID# 221952
- University of Catanzaro /ID# 204546
- Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
- Kyungpook National University Hospital /ID# 209912
- Yeungnam University Medical Center /ID# 210447
- Maastricht Universitair Medisch Centrum /ID# 204428
- Franciscus Gasthuis & Vlietland /ID# 206976
- Elisabeth Tweesteden Ziekenhuis /ID# 206272
- Hospital Santa Creu i Sant Pau /ID# 213259
- Hospital General Universitario Gregorio Maranon /ID# 204504
- Hospital Universitario La Paz /ID# 210065
- NHS Greater Glasgow and Clyde /ID# 206574
- Belfast Health and Social Care Trust /ID# 206744
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ravagalimab 600 mg/300 mg
Arm Description
Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
Clinical response per Partial Adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 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.
Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline
Clinical Remission per full Mayo score is defined as Full Mayo score <=2 with no subscore > 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Endoscopies were assessed by a central reader. Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer.
Percentage of Participants With Endoscopic Remission During Induction Period
Endoscopic remission is defined as Mayo endoscopic subscore = 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any 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 the nearest whole integer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03695185
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
Ulcerative Colitis (UC), ABBV-323, Ravagalimab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ravagalimab 600 mg/300 mg
Arm Type
Experimental
Arm Description
Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102.
Intervention Type
Drug
Intervention Name(s)
Ravagalimab 600 mg
Other Intervention Name(s)
ABBV-323
Intervention Description
Ravagalimab 600 mg was administered intravenously (IV).
Intervention Type
Drug
Intervention Name(s)
Ravagalimab 300 mg
Other Intervention Name(s)
ABBV-323
Intervention Description
Ravagalimab 300 mg was administered subcutaneously (SC).
Primary Outcome Measure Information:
Title
Percentage of Participants With Endoscopic Improvement During Induction Period
Description
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 Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period
Description
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
Title
Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period
Description
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.
Time Frame
At Week 8
Title
Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
Description
Clinical response per Partial Adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 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.
Time Frame
Up to Week 8
Title
Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline
Description
Clinical Remission per full Mayo score is defined as Full Mayo score <=2 with no subscore > 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Endoscopies were assessed by a central reader. Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer.
Time Frame
At Week 8
Title
Percentage of Participants With Endoscopic Remission During Induction Period
Description
Endoscopic remission is defined as Mayo endoscopic subscore = 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any 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 the nearest whole integer.
Time Frame
At Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Banner University Medical Cent /ID# 208392
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Meridian Investigator Network /ID# 204646
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648-5994
Country
United States
Facility Name
Meridian Investigator Network /ID# 218568
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
TLC Clinical Research Inc /ID# 206626
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691-6306
Country
United States
Facility Name
UC Davis Medical Center /ID# 209402
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
The University of Chicago DCAM /ID# 207086
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Affinity Clinical Research /ID# 206211
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
Univ New Mexico /ID# 208817
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Penn Presbyterian Medical Center /ID# 206826
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-2640
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 204670
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Mount Sinai Hospital /ID# 206180
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 208131
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
Hopital Beaujon /ID# 208129
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
CHRU Nancy - Hôpitaux de Brabois /ID# 208133
City
Vandœuvre-lès-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
Universitaetsklinikum Frankfurt /ID# 207569
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 221952
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
University of Catanzaro /ID# 204546
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Kyungpook National University Hospital /ID# 209912
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center /ID# 210447
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Maastricht Universitair Medisch Centrum /ID# 204428
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Franciscus Gasthuis & Vlietland /ID# 206976
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 206272
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Hospital Santa Creu i Sant Pau /ID# 213259
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 204504
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 210065
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
NHS Greater Glasgow and Clyde /ID# 206574
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust /ID# 206744
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://rxabbvie.com
Description
Related Info
Learn more about this trial
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
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