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

Ulcerative Colitis Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04556383
• Other study ID #: GB004-2101
• Secondary ID: 2020-002306-12
• Status: Terminated
• Phase: Phase 2
• Start date: October 19, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2023
• Source: Gossamer Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 236
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. prednisone = 20 mg/day or equivalent or

2. beclomethasone = 5 mg/day or

3. budesonide or budesonide multi-matrix (MMX) of = 9 mg/day

Exclusion Criteria:

• 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. NOTE: Other Inclusion/Exclusion criteria may apply per protocol.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• GB004
oral tablet
• Placebo
oral tablet

Locations

Country	Name	City	State
Georgia	JSC Infectious Diseases, AIDS and Clinical Immunology Research Center	Tbilisi
Georgia	LTD Aversi Clinic	Tbilisi
Georgia	LTD Central University Clinic After Academic N. Kipshidze	Tbilisi
Georgia	LTD Coloproctological Center of Georgia	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD	Tbilisi
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Heaundae Paik Hospital	Busan
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Moldova, Republic of	PMSI Republican Clinical Hospital "Timofei Mosneaga"	Chisinau
Poland	CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska	Bydgoszcz
Poland	St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine	Elblag
Poland	Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA	Jelenia Gora
Poland	Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice	Katowice
Poland	"LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices	Krakow
Poland	Medicome Limited Liability Company, Oswiecim Clinical Trial Centre	Oswiecim
Poland	Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]	Sopot
Poland	"NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK	Staszow
Poland	"Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]	Torun
Poland	EB GROUP Limited Liability Company, MDM Health Centre	Warsaw
Poland	Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center	Warsaw
Poland	VIVAMED Non-Public Healthcare Facility	Warsaw
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw
Poland	Clinical Research Center Piotr Napora Medical Doctors Professional Partnership	Wroclaw
Romania	Colentina Clinical Hospital	Bucharest
Russian Federation	Limited Liability Company Joint Venture Diagnostic Center "Biotherm"	Barnaul
Russian Federation	"Myod" Ltd.	Bataysk
Russian Federation	Federal Siberian Research Clinical Center under the Federal Medical Biological Agency	Krasnoyarsk
Russian Federation	Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department	Moscow
Russian Federation	Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences	Novosibirsk
Russian Federation	Medical Center SibNovoMed, Limited Liability Company	Novosibirsk
Russian Federation	Novosibirskiy Gastrocenter, LLC	Novosibirsk
Russian Federation	Medical Diagnostic Center, Limited Liability Company	Orenburg
Russian Federation	Penza Regional Clinical Hospital named after N.N. Burdenko	Penza
Russian Federation	Clinic UZI 4D, Limited Liability Company	Pyatigorsk
Russian Federation	S.M. Kirov Miltiary Medical Academy	St Petersburg
Russian Federation	Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs	St. Petersburg
Russian Federation	St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38	St. Petersburg
Russian Federation	Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital	Veliky Novgorod
Serbia	Clinical Hospital Center "Dr Dragisa Misovic Dedinje''	Belgrade
Serbia	Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab	Belgrade
Serbia	Clinical Hospital Center Zemun	Belgrade
Serbia	Zvezdara University Medical Center-local lab	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	General Hospital "Djordje Joanovic"	Zrenjanin
Ukraine	Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"	Cherkasy
Ukraine	Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519	Chernivtsi
Ukraine	Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527	Chernivtsi
Ukraine	Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"	Ivano-Frankivsk
Ukraine	PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council	Kharkiv
Ukraine	Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"	Kharkiv
Ukraine	Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"	Kyiv
Ukraine	Medical Center of the Limited Liability Company "Harmoniia Krasy"	Kyiv
Ukraine	Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"	Kyiv
Ukraine	PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council	Kyiv
Ukraine	Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"	Kyiv
Ukraine	The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council	Lutsk
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"	Lviv
Ukraine	Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council	Odesa
Ukraine	Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"	Poltava
Ukraine	Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1	Vinnytsia
Ukraine	MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"	Vinnytsia
Ukraine	MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council	Zaporizhia
Ukraine	PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"	Zaporizhia
Ukraine	Limited Liability Company "Medibor"	Zhytomyr
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
United States	B G Clinical Research, Inc.	Encinitas	California
United States	Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County	Freehold	New Jersey
United States	Gastroenterology Clinic of Acadiana	Lafayette	Louisiana
United States	Gastro Care Institute	Lancaster	California
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Delta Research Partners	Monroe	Louisiana
United States	Mayo Clinic	Rochester	Minnesota
United States	Texas Digestive Disease Consultant	Southlake	Texas
United States	Washington Gastroenterology, PLCC	Tacoma	Washington
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GB004, Inc.

Countries where clinical trial is conducted

United States,  Georgia,  Korea, Republic of,  Moldova, Republic of,  Poland,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With Clinical Response at PCP Week 12	Clinical response is defined as a reduction in Modified Mayo score of = 2 points and = 35% from baseline, including a decrease in rectal bleeding subscore of = 1 or absolute rectal bleeding subscore of = 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
Secondary	Percentage of Participants With Histologic Remission at PCP Week 12	Histologic remission is defined as Robarts Histopathology Index (RHI) = 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. Histologic remission is evaluated among subjects with both baseline lamina propria neutrophils and neutrophils in epithelium RHI subscores > 0.; The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.	At PCP Week 12
Secondary	Percentage of Participants With Endoscopic Improvement at PCP Week 12	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1.; The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.	At PCP Week 12
Secondary	Percentage of Participants With Mucosal Healing at PCP Week 12	Mucosal healing is defined as endoscopic improvement and histologic remission.; Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 12 and for Percentage of Participants With Histologic Remission at PCP Week 12 for information on the measures of endoscopic improvement and histologic remission, respectively.	At PCP Week 12
Secondary	Percentage of Participants With Clinical Remission at PCP Week 36	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 36
Secondary	Percentage of Participants With Clinical Response at PCP Week 36	Clinical response is defined as a reduction in Modified Mayo score of = 2 points and = 35% from baseline, including a decrease in rectal bleeding subscore of = 1 or absolute rectal bleeding subscore of = 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 36
Secondary	Percentage of Participants With Histologic Remission at PCP Week 36	Histologic remission is defined as Robarts Histopathology Index (RHI) = 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0.; The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.	At PCP Week 36
Secondary	Percentage of Participants With Endoscopic Improvement at PCP Week 36	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1.; The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.	At PCP Week 36
Secondary	Percentage of Participants With Mucosal Healing at PCP Week 36	Mucosal healing is defined as endoscopic improvement and histologic remission.; Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 36 and for Percentage of Participants With Histologic Remission at PCP Week 36 for information on the measures of endoscopic improvement and histologic remission, respectively.	At PCP Week 36