Clinical trial NCT04556383: A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Remission at PCP Week 12
timeFrame: At PCP Week 12
measure: Percentage of Participants With a Treatment Emergent Adverse Event
timeFrame: From first dose of OLE study treatment through OLE Week 28
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at PCP Week 12
timeFrame: At PCP Week 12
measure: Percentage of Participants With Histologic Remission at PCP Week 12
timeFrame: At PCP Week 12
measure: Percentage of Participants With Endoscopic Improvement at PCP Week 12
timeFrame: At PCP Week 12
measure: Percentage of Participants With Mucosal Healing at PCP Week 12
timeFrame: At PCP Week 12
measure: Percentage of Participants With Clinical Remission at PCP Week 36
timeFrame: At PCP Week 36
measure: Percentage of Participants With Clinical Response at PCP Week 36
timeFrame: At PCP Week 36
measure: Percentage of Participants With Histologic Remission at PCP Week 36
timeFrame: At PCP Week 36
measure: Percentage of Participants With Endoscopic Improvement at PCP Week 36
timeFrame: At PCP Week 36
measure: Percentage of Participants With Mucosal Healing at PCP Week 36
timeFrame: At PCP Week 36
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: B G Clinical Research, Inc.
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants
state: Louisiana
city: Lafayette
country: United States
facility: Gastroenterology Clinic of Acadiana
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners
state: Louisiana
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Freehold
country: United States
facility: Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County
state: New Jersey
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Southlake
country: United States
facility: Texas Digestive Disease Consultant
state: Texas
city: Bellevue
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology, PLCC
state: Washington
city: Tbilisi
country: Georgia
facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD Central University Clinic After Academic N. Kipshidze
city: Tbilisi
country: Georgia
facility: LTD Coloproctological Center of Georgia
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
city: Busan
country: Korea, Republic of
facility: Inje University Heaundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Chisinau
country: Moldova, Republic of
facility: PMSI Republican Clinical Hospital "Timofei Mosneaga"
city: Bydgoszcz
country: Poland
facility: CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska
city: Elblag
country: Poland
facility: St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine
city: Jelenia Gora
country: Poland
facility: Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA
city: Katowice
country: Poland
facility: Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice
city: Krakow
country: Poland
facility: "LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices
city: Oswiecim
country: Poland
facility: Medicome Limited Liability Company, Oswiecim Clinical Trial Centre
city: Sopot
country: Poland
facility: Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]
city: Staszow
country: Poland
facility: "NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK
city: Toruń
country: Poland
facility: "Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]
city: Warsaw
country: Poland
facility: EB GROUP Limited Liability Company, MDM Health Centre
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warsaw
country: Poland
facility: Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center
city: Warsaw
country: Poland
facility: VIVAMED Non-Public Healthcare Facility
city: Wroclaw
country: Poland
facility: Clinical Research Center Piotr Napora Medical Doctors Professional Partnership
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Barnaul
country: Russian Federation
facility: Limited Liability Company Joint Venture Diagnostic Center "Biotherm"
city: Bataysk
country: Russian Federation
facility: "Myod" Ltd.
city: Krasnoyarsk
country: Russian Federation
facility: Federal Siberian Research Clinical Center under the Federal Medical Biological Agency
city: Moscow
country: Russian Federation
facility: Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed, Limited Liability Company
city: Novosibirsk
country: Russian Federation
facility: Novosibirskiy Gastrocenter, LLC
city: Novosibirsk
country: Russian Federation
facility: Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
city: Orenburg
country: Russian Federation
facility: Medical Diagnostic Center, Limited Liability Company
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N. Burdenko
city: Pyatigorsk
country: Russian Federation
facility: Clinic UZI 4D, Limited Liability Company
city: St Petersburg
country: Russian Federation
facility: S.M. Kirov Miltiary Medical Academy
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38
city: St. Petersburg
country: Russian Federation
facility: Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs
city: Veliky Novgorod
country: Russian Federation
facility: Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Dr Dragisa Misovic Dedinje''
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center-local lab
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Zrenjanin
country: Serbia
facility: General Hospital "Djordje Joanovic"
city: Cherkasy
country: Ukraine
facility: Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
city: Chernivtsi
country: Ukraine
facility: Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519
city: Chernivtsi
country: Ukraine
facility: Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527
city: Ivano-Frankivsk
country: Ukraine
facility: Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
city: Kharkiv
country: Ukraine
facility: PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"
city: Kyiv
country: Ukraine
facility: PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council
city: Kyiv
country: Ukraine
facility: Medical Center of the Limited Liability Company "Harmoniia Krasy"
city: Kyiv
country: Ukraine
facility: Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
city: Kyiv
country: Ukraine
facility: Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"
city: Kyiv
country: Ukraine
facility: Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"
city: Lutsk
country: Ukraine
facility: The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
city: Odesa
country: Ukraine
facility: Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
city: Poltava
country: Ukraine
facility: Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"
city: Vinnytsia
country: Ukraine
facility: MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1
city: Zaporizhia
country: Ukraine
facility: PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"
city: Zaporizhia
country: Ukraine
facility: MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council
city: Zhytomyr
country: Ukraine
facility: Limited Liability Company "Medibor"
Study officials:
References:
citation: 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.