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

NCT03695185 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: M15-7222018-000930-37
• Study Type: interventional
• Target: 42
• Locations: 10 countries
• Sites: 34

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.

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis (UC); ABBV-323; Ravagalimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period

  At Week 8

• Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period

  At Week 8

• Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score

  Up to Week 8

• 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

• Percentage of Participants With Endoscopic Remission During Induction Period

  At Week 8

Study Arms (1)

Ravagalimab 600 mg/300 mg

EXPERIMENTAL

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.

Drug: Ravagalimab 600 mg; Drug: Ravagalimab 300 mg

Interventions

Ravagalimab 600 mg DRUG

Ravagalimab 600 mg was administered intravenously (IV).

Also known as: ABBV-323

Ravagalimab 600 mg/300 mg

Ravagalimab 300 mg DRUG

Ravagalimab 300 mg was administered subcutaneously (SC).

Also known as: ABBV-323

Ravagalimab 600 mg/300 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (34)

Banner University Medical Cent /ID# 208392

Tucson, Arizona, 85724, United States

Location

Meridian Investigator Network /ID# 204646

Huntington Beach, California, 92648-5994, United States

Location

Meridian Investigator Network /ID# 218568

Lakewood, California, 90712, United States

Location

TLC Clinical Research Inc /ID# 206626

Los Angeles, California, 90048, United States

Location

Orange County Institute of Gastroenterology and Endoscopy /ID# 207405

Mission Viejo, California, 92691-6306, United States

Location

UC Davis Medical Center /ID# 209402

Sacramento, California, 95817, United States

Location

The University of Chicago DCAM /ID# 207086

Chicago, Illinois, 60637, United States

Location

Affinity Clinical Research /ID# 206211

Oak Brook, Illinois, 60523-1245, United States

Location

Univ New Mexico /ID# 208817

Albuquerque, New Mexico, 87131, United States

Location

Penn Presbyterian Medical Center /ID# 206826

Philadelphia, Pennsylvania, 19104-2640, United States

Location

Vanderbilt University Medical Center /ID# 204670

Nashville, Tennessee, 37232-0011, United States

Location

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

San Antonio, Texas, 78212, United States

Location

Mount Sinai Hospital /ID# 206180

Toronto, Ontario, M5G 1X5, Canada

Location

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

Nice, Alpes-Maritimes, 06200, France

Location

CHRU Nancy - Hôpitaux de Brabois /ID# 208133

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

Location

Hopital Beaujon /ID# 208129

Clichy, Île-de-France Region, 92110, France

Location

Universitaetsklinikum Frankfurt /ID# 207569

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570

Berlin, 10117, Germany

Location

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

Szeged, Csongrád megye, 6725, Hungary

Location

Debreceni Egyetem Klinikai Kozpont /ID# 221952

Debrecen, 4032, Hungary

Location

University of Catanzaro /ID# 204546

Catanzaro, Calabria, 88100, Italy

Location

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

Rome, Roma, 00168, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504

Milan, 20122, Italy

Location

Maastricht Universitair Medisch Centrum /ID# 204428

Maastricht, 6229 HX, Netherlands

Location

Franciscus Gasthuis & Vlietland /ID# 206976

Rotterdam, 3045 PM, Netherlands

Location

Elisabeth Tweesteden Ziekenhuis /ID# 206272

Tilburg, 5022 GC, Netherlands

Location

Kyungpook National University Hospital /ID# 209912

Daegu, 41944, South Korea

Location

Yeungnam University Medical Center /ID# 210447

Daegu, 42415, South Korea

Location

Hospital Santa Creu i Sant Pau /ID# 213259

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 204504

Madrid, 28007, Spain

Location

Hospital Universitario La Paz /ID# 210065

Madrid, 28046, Spain

Location

NHS Greater Glasgow and Clyde /ID# 206574

Glasgow, Scotland, G12 0XH, United Kingdom

Location

Belfast Health and Social Care Trust /ID# 206744

Belfast, BT9 7AB, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: March 26, 2019
• Primary Completion: April 5, 2021
• Study Completion: January 10, 2022
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CA (1); DE (3); KR (2); NL (3); ES (3); US (12); IT (3); FR (3); HU (2); GB (2)