Clinical trial NCT03695185: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis (UC)
Keywords: Ulcerative Colitis (UC)
ABBV-323
Ravagalimab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Endoscopic Improvement During Induction Period
timeFrame: At Week 8
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period
timeFrame: At Week 8
measure: Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period
timeFrame: At Week 8
measure: Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score
timeFrame: Up to Week 8
measure: 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
timeFrame: At Week 8
measure: Percentage of Participants With Endoscopic Remission During Induction Period
timeFrame: At Week 8
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Cent /ID# 208392
state: Arizona
city: Huntington Beach
country: United States
facility: Meridian Investigator Network /ID# 204646
state: California
city: Lakewood
country: United States
facility: Meridian Investigator Network /ID# 218568
state: California
city: Los Angeles
country: United States
facility: TLC Clinical Research Inc /ID# 206626
state: California
city: Mission Viejo
country: United States
facility: Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center /ID# 209402
state: California
city: Chicago
country: United States
facility: The University of Chicago DCAM /ID# 207086
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 206211
state: Illinois
city: Albuquerque
country: United States
facility: Univ New Mexico /ID# 208817
state: New Mexico
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center /ID# 206826
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 204670
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 204689
state: Texas
city: Toronto
country: Canada
facility: Mount Sinai Hospital /ID# 206180
state: Ontario
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 208131
state: Alpes-Maritimes
city: Clichy
country: France
facility: Hopital Beaujon /ID# 208129
state: Ile-de-France
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy - Hôpitaux de Brabois /ID# 208133
state: Meurthe-et-Moselle
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 207569
state: Hessen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 221952
city: Catanzaro
country: Italy
facility: University of Catanzaro /ID# 204546
state: Calabria
city: Rome
country: Italy
facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549
state: Roma
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 209912
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center /ID# 210447
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum /ID# 204428
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland /ID# 206976
city: Tilburg
country: Netherlands
facility: Elisabeth Tweesteden Ziekenhuis /ID# 206272
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 213259
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 204504
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 210065
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 206574
state: Scotland
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust /ID# 206744
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: