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

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

Sponsors

Lead Sponsor: GB004, Inc.

Source Gossamer Bio Inc.
Brief Summary

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of 2 dose regimens of GB004 in adult subjects with mild-to-moderate active UC and who have disease activity despite treatment with 5-aminosalicylate (5-ASA). The primary objective of this study is to evaluate the effect of GB004 compared to placebo on clinical remission.

Overall Status Recruiting
Start Date September 2020
Completion Date April 2022
Primary Completion Date March 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of Participants With Clinical Remission at Week 12 12 weeks
Secondary Outcome
Measure Time Frame
Proportion of Participants with Clinical Response at Week 12 12 weeks
Proportion of Participants with Histologic Remission at Week 12 12 weeks
Proportion of Participants with Endoscopic Improvement at Week 12 12 weeks
Proportion of Participants with Mucosal Healing at Week 12 12 weeks
Enrollment 195
Condition
Intervention

Intervention Type: Drug

Intervention Name: GB004

Description: GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Placebo

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 treatments: 1. prednisone ≤ 20 mg/day or equivalent or 2. 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 myocophenolate mofetil within 8 weeks of Day 1. - Azathioprine, or 6-mercaptopurine within 1 day of Day 1. NOTE: Other Inclusion/Exlcusion criteria may apply per protocol.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Barrett Levesque, MD Study Director Gossamer Bio Inc.
Overall Contact

Last Name: Gossamer Bio, Inc

Phone: 1-866-668-4083

Email: [email protected]

Location
Facility: Status: Contact:
Gastro SB Clinic | Chula Vista, California, 91910, United States Recruiting Principal Investigator
Gastro Care Institute | Lancaster, California, 93534, United States Recruiting Principal Investigator
Delta Research Partners | Monroe, Louisiana, 71201, United States Recruiting Principal Investigator
Las Vegas Medical Research | Las Vegas, Nevada, 89113, United States Recruiting Principal Investigator
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: GB004 dose A

Type: Experimental

Description: GB004 dose A for oral administration

Label: GB004 dose B

Type: Experimental

Description: GB004 dose B for oral administration

Label: Placebo

Type: Placebo Comparator

Description: Placebo for oral administration

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.

Source: ClinicalTrials.gov