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
NCT ID: NCT03695185
Last Updated: 2023-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2019-03-26
2022-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ravagalimab 600 mg/300 mg
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.
Ravagalimab 600 mg
Ravagalimab 600 mg was administered intravenously (IV).
Ravagalimab 300 mg
Ravagalimab 300 mg was administered subcutaneously (SC).
Interventions
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Ravagalimab 600 mg
Ravagalimab 600 mg was administered intravenously (IV).
Ravagalimab 300 mg
Ravagalimab 300 mg was administered subcutaneously (SC).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Vanderbilt University Medical Center /ID# 204670
Nashville, Tennessee, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
San Antonio, Texas, United States
Mount Sinai Hospital /ID# 206180
Toronto, Ontario, Canada
Chu de Nice-Hopital L'Archet Ii /Id# 208131
Nice, Alpes-Maritimes, France
CHRU Nancy - Hôpitaux de Brabois /ID# 208133
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hopital Beaujon /ID# 208129
Clichy, Île-de-France Region, France
Universitaetsklinikum Frankfurt /ID# 207569
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
Berlin, , Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 221952
Debrecen, , Hungary
University of Catanzaro /ID# 204546
Catanzaro, Calabria, Italy
Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
Rome, Roma, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
Milan, , Italy
Maastricht Universitair Medisch Centrum /ID# 204428
Maastricht, , Netherlands
Franciscus Gasthuis & Vlietland /ID# 206976
Rotterdam, , Netherlands
Elisabeth Tweesteden Ziekenhuis /ID# 206272
Tilburg, , Netherlands
Kyungpook National University Hospital /ID# 209912
Daegu, , South Korea
Yeungnam University Medical Center /ID# 210447
Daegu, , South Korea
Hospital Santa Creu i Sant Pau /ID# 213259
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 204504
Madrid, , Spain
Hospital Universitario La Paz /ID# 210065
Madrid, , Spain
NHS Greater Glasgow and Clyde /ID# 206574
Glasgow, Scotland, United Kingdom
Belfast Health and Social Care Trust /ID# 206744
Belfast, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2018-000930-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-722
Identifier Type: -
Identifier Source: org_study_id
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