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

Ulcerative Colitis (UC) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695185
• Other study ID #: M15-722
• Secondary ID: 2018-000930-37
• Status: Completed
• Phase: Phase 2
• Start date: March 26, 2019
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 10, 2022
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• Ravagalimab 600 mg
Ravagalimab 600 mg was administered intravenously (IV).
• Ravagalimab 300 mg
Ravagalimab 300 mg was administered subcutaneously (SC).

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital /ID# 206180	Toronto	Ontario
France	Hopital Beaujon /ID# 208129	Clichy	Ile-de-France
France	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
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570	Berlin
Germany	Universitaetsklinikum Frankfurt /ID# 207569	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571	Kiel	Schleswig-Holstein
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 221952	Debrecen
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576	Szeged	Csongrad
Italy	University of Catanzaro /ID# 204546	Catanzaro	Calabria
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504	Milan
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549	Rome	Roma
Korea, Republic of	Kyungpook National University Hospital /ID# 209912	Daegu
Korea, Republic of	Yeungnam University Medical Center /ID# 210447	Daegu
Netherlands	Maastricht Universitair Medisch Centrum /ID# 204428	Maastricht
Netherlands	Franciscus Gasthuis & Vlietland /ID# 206976	Rotterdam
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 206272	Tilburg
Spain	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
United Kingdom	Belfast Health and Social Care Trust /ID# 206744	Belfast
United Kingdom	NHS Greater Glasgow and Clyde /ID# 206574	Glasgow	Scotland
United States	Univ New Mexico /ID# 208817	Albuquerque	New Mexico
United States	The University of Chicago DCAM /ID# 207086	Chicago	Illinois
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	Vanderbilt University Medical Center /ID# 204670	Nashville	Tennessee
United States	Affinity Clinical Research /ID# 206211	Oak Brook	Illinois
United States	Penn Presbyterian Medical Center /ID# 206826	Philadelphia	Pennsylvania
United States	UC Davis Medical Center /ID# 209402	Sacramento	California
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 204689	San Antonio	Texas
United States	Banner University Medical Cent /ID# 208392	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Endoscopic Improvement During Induction Period	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.	At Week 8
Secondary	Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period	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.	At Week 8
Secondary	Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period	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.	At Week 8
Secondary	Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score	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.	Up to Week 8
Secondary	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	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.	At Week 8
Secondary	Percentage of Participants With Endoscopic Remission During Induction Period	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.	At Week 8

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