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

Completed · Phase 2

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT03695185

Run by

AbbVie

People needed

42

Starts

2019-03-26

Expected to finish

2022-01-10

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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