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Trial record 1 of 1 for:    GB004-2101
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A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

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ClinicalTrials.gov Identifier: NCT04556383
Recruitment Status : Active, not recruiting
First Posted : September 21, 2020
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB004, Inc. )

Brief Summary:
A 2-part study, comprising of a 36-week placebo-controlled period and a 24-week open-label extension 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: GB004 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
Primary Purpose: Treatment
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
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GB004 Dose A
GB004 dose A for oral administration for 36 weeks
Drug: GB004
GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer

Experimental: GB004 Dose B
GB004 dose B for oral administration for 36 weeks
Drug: GB004
GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer

Placebo Comparator: Placebo
Placebo for oral administration for 36 weeks
Drug: Placebo
Placebo

Experimental: Open-Label GB004 Dose A
GB004 dose A for oral administration for 24 weeks
Drug: GB004
GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer




Primary Outcome Measures :
  1. Proportion of Participants With Clinical Remission at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of Participants with Clinical Response at Week 12 [ Time Frame: 12 weeks ]
  2. Proportion of Participants with Histologic Remission at Week 12 [ Time Frame: 12 weeks ]
  3. Proportion of Participants with Endoscopic Improvement at Week 12 [ Time Frame: 12 weeks ]
  4. Proportion of Participants with Mucosal Healing at Week 12 [ Time Frame: 12 weeks ]
  5. Proportion of Participants with Clinical Remission at Week 36 [ Time Frame: 36 weeks ]
  6. Proportion of Participants with Clinical Response at Week 36 [ Time Frame: 36 weeks ]
  7. Proportion of Participants with Histologic Remission at Week 36 [ Time Frame: 36 weeks ]
  8. Proportion of Participants with Endoscopic Improvement at Week 36 [ Time Frame: 36 weeks ]
  9. Proportion of Patients with Mucosal Healing at Week 36 [ Time Frame: 36 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556383


Locations
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Sponsors and Collaborators
GB004, Inc.
Investigators
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Study Director: Barrett Levesque, MD Gossamer Bio Inc.
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Responsible Party: GB004, Inc.
ClinicalTrials.gov Identifier: NCT04556383    
Other Study ID Numbers: GB004-2101
2020-002306-12 ( EudraCT Number )
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gossamer Bio Inc. ( GB004, Inc. ):
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases