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

Last updated: February 16, 2023
Sponsor: AbbVie
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT03695185
M15-722
2018-000930-37
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must voluntarily sign and date an informed consent, approved by anindependent ethics committee (IEC)/institutional review board (IRB), prior to theinitiation of any screening or study-specific procedures.
  • Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation ofbiopsy results consistent with the diagnosis of UC in the assessment of theInvestigator, must be available.
  • Participant meets the following disease activity criteria: Active UC with an AdaptedMayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by centralreview).
  • History of inadequate response, loss of response, or intolerance to one or more of theapproved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/ortofacitinib (Note: If tofacitinib was received in a clinical trial, subject must havereceived open-label drug).

Exclusion

Exclusion Criteria:

  • Participant having an active, chronic, or recurrent infection that based onInvestigator's clinical assessment makes the participant an unsuitable candidate forthe study.
  • Participant having any malignancy except for successfully treated non-metastaticcutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of thecervix.
  • Participant with history of dysplasia of the gastrointestinal tract or evidence ofdysplasia in any biopsy performed during the screening endoscopy other than completelyremoved 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 whiteblood cell (WBC) count >= 3.0*10^9/L.

Study Design

Total Participants: 42
Study Start date:
March 26, 2019
Estimated Completion Date:
January 10, 2022

Connect with a study center

  • Zeidler Ledcor Centre /ID# 205069

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Mount Sinai Hospital /ID# 206180

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Montreal General Hospital /ID# 204732

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Montreal General Hospital /ID# 204732

    Montréal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Chu de Nice-Hopital L'Archet Ii /Id# 208131

    Nice, Alpes-Maritimes 06200
    France

    Site Not Available

  • Chu de Nice-Hopital L'Archet Ii /Id# 208131

    Nice CEDEX 3, Alpes-Maritimes 06202
    France

    Site Not Available

  • CHRU Lille - Hôpital Claude Huriez /ID# 208132

    Lille CEDEX, Hauts-de-France 59045
    France

    Site Not Available

  • Hopital Beaujon /ID# 208129

    Clichy, Ile-de-France 92110
    France

    Site Not Available

  • CHU NANCY - Hopital Brabois Adultes /ID# 208133

    Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle 54511
    France

    Site Not Available

  • CHRU Nancy - Hôpitaux de Brabois /ID# 208133

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54500
    France

    Site Not Available

  • Universitaetsklinikum Frankfurt /ID# 207569

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570

    Berlin, 10117
    Germany

    Site Not Available

  • Universitaetklinikum Dresden /ID# 209962

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt /ID# 207569

    Frankfurt, 60590
    Germany

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576

    Szeged, Csongrad 6725
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont /ID# 221952

    Debrecen, 4032
    Hungary

    Site Not Available

  • University of Catanzaro /ID# 204546

    Catanzaro, Calabria 88100
    Italy

    Site Not Available

  • Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549

    Rome, Roma 00168
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504

    Milan, 20122
    Italy

    Site Not Available

  • Kyungpook National University Hospital /ID# 209912

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Yeungnam University Medical Center /ID# 210447

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Maastricht Universitair Medisch Centrum /ID# 204428

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Franciscus Gasthuis & Vlietland /ID# 206976

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Elisabeth Tweesteden Ziekenhuis /ID# 206272

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • Hospital Santa Creu i Sant Pau /ID# 213259

    Barcelona, 08041
    Spain

    Site Not Available

  • Hosp Univ Girona Josep Trueta /ID# 208230

    Girona, 17007
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon /ID# 204504

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Paz /ID# 210065

    Madrid, 28046
    Spain

    Site Not Available

  • NHS Greater Glasgow and Clyde /ID# 206574

    Glasgow, Scotland G12 0XH
    United Kingdom

    Site Not Available

  • Belfast Health and Social Care Trust /ID# 206744

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • St. George's Healthcare NHS /ID# 206745

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Banner University Medical Cent /ID# 208392

    Tucson, Arizona 85724
    United States

    Site Not Available

  • TLC Clinical Research Inc /ID# 206626

    Beverly Hills, California 90211-2091
    United States

    Site Not Available

  • Meridian Investigator Network /ID# 204646

    Huntington Beach, California 92648-5994
    United States

    Site Not Available

  • Meridian Investigator Network /ID# 218568

    Lakewood, California 90712
    United States

    Site Not Available

  • TLC Clinical Research Inc /ID# 206626

    Los Angeles, California 90048
    United States

    Site Not Available

  • Orange County Institute of Gastroenterology and Endoscopy /ID# 207405

    Mission Viejo, California 92691-6306
    United States

    Site Not Available

  • Meridian Investigator Network /ID# 204646

    Newport Beach, California 92660
    United States

    Site Not Available

  • UC Davis Medical Center /ID# 209402

    Sacramento, California 95817
    United States

    Site Not Available

  • University of South Florida /ID# 210180

    Tampa, Florida 33612
    United States

    Site Not Available

  • The University of Chicago DCAM /ID# 207086

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Chicago Association for Research and Education in Science (CARES) /ID# 208092

    North Chicago, Illinois 60064-3048
    United States

    Site Not Available

  • Affinity Clinical Research /ID# 206211

    Oak Brook, Illinois 60523-1245
    United States

    Site Not Available

  • Univ New Mexico /ID# 208817

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Penn Presbyterian Medical Center /ID# 206826

    Philadelphia, Pennsylvania 19104-2640
    United States

    Site Not Available

  • Vanderbilt University Medical Center /ID# 204670

    Nashville, Tennessee 37232-0011
    United States

    Site Not Available

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 204689

    San Antonio, Texas 78212
    United States

    Site Not Available

  • CHI Franciscan Research Center /ID# 205142

    Tacoma, Washington 98405
    United States

    Site Not Available

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