Ulcerative ColitisPhase 1NCT03860896
GB004 in Adult Subjects With Active Ulcerative Colitis
A Phase 1 study testing GB004 in people with Ulcerative Colitis, run by GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- GB004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 Apr 2019to 17 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.
Who cannot join
- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- Patients receiving biologic agents and experimental agents are excluded.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Moldova1 site
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, MD2025
About this study
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
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- GB004, Placebo
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB004Drug
GB0004 high dose
PlaceboDrug
Placebo
GB004Drug
GB004 low dose
| Study group | Role | What they receive |
|---|---|---|
| GB004 | Experimental | GB004 for oral administration daily Receives: Drug: GB004 |
| Placebo | Placebo comparator | Placebo for oral administration daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 Days
Secondary outcomes (3)
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Measured: Day 1 to Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Measured: Day 1 to Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start24 Apr 2019
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860896
- Sponsor's protocol ID
- GB004-1101
- Status last verified
- Jan 2020
- First submitted
- 14 Feb 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35014040
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03860896
- Acronym / sponsor ID
- GB004-1101
- Conditions
- Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB004 | Experimental | Drug: GB004GB004 for oral administration daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for oral administration daily |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.
Key exclusion criteria (2 listed)
- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- Patients receiving biologic agents and experimental agents are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB004GB0004 high dose | Drug | GB004 |
| PlaceboPlacebo | Drug | Placebo |
| GB004GB004 low dose | Drug | GB004 |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 56 Days
To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.
3 secondary outcomes
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004
Time frame: Day 1 to Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of GB004
Time frame: Day 1 to Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004
Time frame: Day 1 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 35014040Danese 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB004 in people with Ulcerative Colitis, run by GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: 56 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.