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GB004 in Adult Subjects With Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GB004
Placebo
GB004
Sponsored by
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Inflammatory Bowel Disease, Ulcerative Colitis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.

Exclusion Criteria:

  • Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
  • Patients receiving biologic agents and experimental agents are excluded.

Sites / Locations

  • Delta Research Partners
  • Arensia Exploratory Medicine
  • PMSI Republican Clinical Hospital "Timofei Mosneaga"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GB004

Placebo

Arm Description

GB004 for oral administration daily

Placebo for oral administration daily

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.

Secondary Outcome Measures

Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004

Full Information

First Posted
February 14, 2019
Last Updated
January 13, 2020
Sponsor
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03860896
Brief Title
GB004 in Adult Subjects With Active Ulcerative Colitis
Official Title
A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.
Detailed Description
The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Inflammatory Bowel Disease, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GB004
Arm Type
Experimental
Arm Description
GB004 for oral administration daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for oral administration daily
Intervention Type
Drug
Intervention Name(s)
GB004
Intervention Description
GB0004 high dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
GB004
Intervention Description
GB004 low dose
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Description
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
Time Frame
56 Days
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Time Frame
Day 1 to Day 28
Title
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Time Frame
Day 1 to Day 28
Title
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
Time Frame
Day 1 to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation. Exclusion Criteria: Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection. Patients receiving biologic agents and experimental agents are excluded.
Facility Information:
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Arensia Exploratory Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
PMSI Republican Clinical Hospital "Timofei Mosneaga"
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35014040
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.
Results Reference
derived

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GB004 in Adult Subjects With Active Ulcerative Colitis

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