A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

NCT04556383 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: GB004-21012020-002306-12
• Study Type: interventional
• Target: 236
• Locations: 9 countries
• Sites: 77

Brief Summary

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Clinical Remission at PCP Week 12

  Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.

  At PCP Week 12

• Percentage of Participants With a Treatment Emergent Adverse Event

  An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs. An AE was considered treatment-emergent to the OLE if it started on or after the first dose of OLE study treatment.

  From first dose of OLE study treatment through OLE Week 28

Secondary Outcomes (9)

• Percentage of Participants With Clinical Response at PCP Week 12

  At PCP Week 12

• Percentage of Participants With Histologic Remission at PCP Week 12

  At PCP Week 12

• Percentage of Participants With Endoscopic Improvement at PCP Week 12

  At PCP Week 12

• Percentage of Participants With Mucosal Healing at PCP Week 12

  At PCP Week 12

• Percentage of Participants With Clinical Remission at PCP Week 36

  At PCP Week 36

Study Arms (4)

PCP Placebo

PLACEBO COMPARATOR

PCP Placebo for oral administration for 36 weeks

Drug: Placebo

PCP GB004 480 mg QD

EXPERIMENTAL

PCP GB004 480 mg QD for oral administration for 36 weeks

Drug: GB004

PCP GB004 480 mg BID

EXPERIMENTAL

PCP GB004 480 mg BID for oral administration for 36 weeks

Drug: GB004

Open-Label Extension (OLE) GB004 480 mg BID

EXPERIMENTAL

OLE GB004 480 mg BID for oral administration for 24 weeks

Drug: GB004

Interventions

GB004 DRUG

oral tablet

Open-Label Extension (OLE) GB004 480 mg BID; PCP GB004 480 mg BID; PCP GB004 480 mg QD

Placebo DRUG

oral tablet

PCP Placebo

Eligibility Criteria

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

You may qualify if:

• Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
• UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
• Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:
• prednisone ≤ 20 mg/day or equivalent or
• beclomethasone ≤ 5 mg/day or
• budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

You may not qualify if:

• Prior approved biologic therapy used for the treatment of UC.
• Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
• Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
• Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

Sponsors & Collaborators

• GB004, Inc.: lead

Study Sites (77)

B G Clinical Research, Inc.

Encinitas, California, 92024, United States

Location

Gastro Care Institute

Lancaster, California, 93534, United States

Location

Texas Digestive Disease Consultants

Baton Rouge, Louisiana, 70809, United States

Location

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County

Freehold, New Jersey, 07728, United States

Location

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

Location

Texas Digestive Disease Consultant

Southlake, Texas, 76092, United States

Location

Washington Gastroenterology, PLLC

Bellevue, Washington, 98004, United States

Location

Washington Gastroenterology, PLCC

Tacoma, Washington, 98405, United States

Location

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0160, Georgia

Location

LTD Aversi Clinic

Tbilisi, 0160, Georgia

Location

LTD Central University Clinic After Academic N. Kipshidze

Tbilisi, 0160, Georgia

Location

LTD Coloproctological Center of Georgia

Tbilisi, 0160, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

Tbilisi, 0172, Georgia

Location

PMSI Republican Clinical Hospital "Timofei Mosneaga"

Chisinau, MD2025, Moldova

Location

CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, 85-794, Poland

Location

St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine

Elblag, 82-300, Poland

Location

Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA

Jelenia Góra, 58-500, Poland

Location

Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice

Katowice, 40-752, Poland

Location

"LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices

Krakow, 31-156, Poland

Location

Medicome Limited Liability Company, Oswiecim Clinical Trial Centre

Oświęcim, 32-600, Poland

Location

Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]

Sopot, 81-756, Poland

Location

"NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK

Staszów, 28-200, Poland

Location

"Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]

Torun, 87-100, Poland

Location

EB GROUP Limited Liability Company, MDM Health Centre

Warsaw, 00-635, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center

Warsaw, 02-665, Poland

Location

VIVAMED Non-Public Healthcare Facility

Warsaw, 03-580, Poland

Location

Clinical Research Center Piotr Napora Medical Doctors Professional Partnership

Wroclaw, 51-162, Poland

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Limited Liability Company Joint Venture Diagnostic Center "Biotherm"

Barnaul, 656015, Russia

Location

"Myod" Ltd.

Bataysk, 346880, Russia

Location

Federal Siberian Research Clinical Center under the Federal Medical Biological Agency

Krasnoyarsk, 660037, Russia

Location

Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department

Moscow, 115516, Russia

Location

Medical Center SibNovoMed, Limited Liability Company

Novosibirsk, 630005, Russia

Location

Novosibirskiy Gastrocenter, LLC

Novosibirsk, 630007, Russia

Location

Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences

Novosibirsk, 630089, Russia

Location

Medical Diagnostic Center, Limited Liability Company

Orenburg, 460051, Russia

Location

Penza Regional Clinical Hospital named after N.N. Burdenko

Penza, 440026, Russia

Location

Clinic UZI 4D, Limited Liability Company

Pyatigorsk, 357502, Russia

Location

S.M. Kirov Miltiary Medical Academy

Saint Petersburg, 191015, Russia

Location

St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38

Saint Petersburg, 191015, Russia

Location

Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs

Saint Petersburg, 197110, Russia

Location

Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital

Veliky Novgorod, 173008, Russia

Location

Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab

Belgrade, 11000, Serbia

Location

Clinical Hospital Center "Dr Dragisa Misovic Dedinje''

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zemun

Belgrade, 11000, Serbia

Location

Zvezdara University Medical Center-local lab

Belgrade, 11000, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

Location

Inje University Heaundae Paik Hospital

Busan, 48018, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"

Cherkasy, 18009, Ukraine

Location

Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519

Chernivtsi, 58001, Ukraine

Location

Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527

Chernivtsi, 58001, Ukraine

Location

Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"

Ivano-Frankivsk, 76008, Ukraine

Location

PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council

Kharkiv, 61037, Ukraine

Location

Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"

Kharkiv, 61058, Ukraine

Location

PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council

Kyiv, 01030, Ukraine

Location

Medical Center of the Limited Liability Company "Harmoniia Krasy"

Kyiv, 01135, Ukraine

Location

Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"

Kyiv, 02091, Ukraine

Location

Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"

Kyiv, 04050, Ukraine

Location

Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"

Kyiv, 04078, Ukraine

Location

The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council

Lutsk, 43005, Ukraine

Location

Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

Lviv, 79010, Ukraine

Location

Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council

Odesa, 65025, Ukraine

Location

Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"

Poltava, 36011, Ukraine

Location

MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"

Vinnytsia, 21028, Ukraine

Location

Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1

Vinnytsia, 21029, Ukraine

Location

PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"

Zaporizhia, 69005, Ukraine

Location

MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council

Zaporizhia, 69600, Ukraine

Location

Limited Liability Company "Medibor"

Zhytomyr, 10002, Ukraine

Location

Related Publications (1)

• Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10.

  PMID: 35014040 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GB004, Inc. Study Director
• Organization: GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

ClinicalTrials@gossamerbio.com

1-866-668-4083

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: October 19, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6); US (13); PL (14); KR (3); UA (20); RO (1); MO (1); GE (5); RU (14)