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
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- Registration Number
- NCT03695185
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ravagalimab 600 mg/300 mg Ravagalimab 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/300 mg Ravagalimab 600 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Endoscopic Improvement During Induction Period At Week 8 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
Name Time Method Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score Up to Week 8 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 Response Per Adapted Mayo Score During Induction Period At Week 8 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 Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline At Week 8 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 Clinical Remission Per Adapted Mayo Score During Induction Period At Week 8 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 Endoscopic Remission During Induction Period At Week 8 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.
Trial Locations
- Locations (34)
Banner University Medical Cent /ID# 208392
🇺🇸Tucson, Arizona, United States
Meridian Investigator Network /ID# 218568
🇺🇸Lakewood, California, United States
The University of Chicago DCAM /ID# 207086
🇺🇸Chicago, Illinois, United States
Chu de Nice-Hopital L'Archet Ii /Id# 208131
🇫🇷Nice, Alpes-Maritimes, France
Hopital Beaujon /ID# 208129
🇫🇷Clichy, Ile-de-France, France
Universitaetsklinikum Frankfurt /ID# 207569
🇩🇪Frankfurt am Main, Hessen, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570
🇩🇪Berlin, Germany
Debreceni Egyetem Klinikai Kozpont /ID# 221952
ðŸ‡ðŸ‡ºDebrecen, 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
Yeungnam University Medical Center /ID# 210447
🇰🇷Daegu, Korea, Republic of
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
CHRU Nancy - Hôpitaux de Brabois /ID# 208133
🇫🇷Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
TLC Clinical Research Inc /ID# 206626
🇺🇸Los Angeles, California, United States
Meridian Investigator Network /ID# 204646
🇺🇸Huntington Beach, California, United States
Orange County Institute of Gastroenterology and Endoscopy /ID# 207405
🇺🇸Mission Viejo, California, United States
Penn Presbyterian Medical Center /ID# 206826
🇺🇸Philadelphia, Pennsylvania, United States
Affinity Clinical Research /ID# 206211
🇺🇸Oak Brook, Illinois, United States
Univ New Mexico /ID# 208817
🇺🇸Albuquerque, New Mexico, United States
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576
ðŸ‡ðŸ‡ºSzeged, Csongrad, Hungary
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571
🇩🇪Kiel, Schleswig-Holstein, Germany
Elisabeth Tweesteden Ziekenhuis /ID# 206272
🇳🇱Tilburg, Netherlands
UC Davis Medical Center /ID# 209402
🇺🇸Sacramento, California, 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
Franciscus Gasthuis & Vlietland /ID# 206976
🇳🇱Rotterdam, Netherlands
Kyungpook National University Hospital /ID# 209912
🇰🇷Daegu, Korea, Republic of
Mount Sinai Hospital /ID# 206180
🇨🇦Toronto, Ontario, Canada
Maastricht Universitair Medisch Centrum /ID# 204428
🇳🇱Maastricht, Netherlands