GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
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ClinicalTrials.gov Identifier: NCT04456998 |
Recruitment Status :
Completed
First Posted : July 7, 2020
Results First Posted : November 7, 2023
Last Update Posted : November 7, 2023
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Sponsor:
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )
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Tracking Information | |||||
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First Submitted Date ICMJE | June 30, 2020 | ||||
First Posted Date ICMJE | July 7, 2020 | ||||
Results First Submitted Date ICMJE | October 16, 2023 | ||||
Results First Posted Date ICMJE | November 7, 2023 | ||||
Last Update Posted Date | November 7, 2023 | ||||
Actual Study Start Date ICMJE | November 12, 2020 | ||||
Actual Primary Completion Date | October 17, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline, Week 24 ] PVR was evaluated using right heart catheterization (RHC).
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Original Primary Outcome Measures ICMJE |
Change from Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline, 24 weeks ] Change in PVR using right heart catheterization (RHC)
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT) [ Time Frame: Baseline, Week 24 ] The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
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Original Secondary Outcome Measures ICMJE |
Change From Baseline to Week 24 on the Six-Minute Walk Test (6MWT) [ Time Frame: Baseline, 24 weeks ] Change in distance achieved on the 6MWT (Δ6MWD)
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) | ||||
Official Title ICMJE | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) | ||||
Brief Summary | The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: Subjects, investigators, other site personnel, and Sponsor (and/or designee) personnel who are directly involved in the conduct of the study, collection of the data, and analysis of the final safety and efficacy results will remain blinded to treatment assignments until after the completion of the study and the database has been locked. Primary Purpose: Treatment
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Condition ICMJE | Pulmonary Artery Hypertension | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
86 | ||||
Original Estimated Enrollment ICMJE |
80 | ||||
Actual Study Completion Date ICMJE | November 1, 2022 | ||||
Actual Primary Completion Date | October 17, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
NOTE: Additional inclusion/exclusion criteria may apply, per protocol. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, Czechia, France, Germany, Serbia, Spain, United Kingdom, United States | ||||
Removed Location Countries | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT04456998 | ||||
Other Study ID Numbers ICMJE | GB002-2101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Gossamer Bio Inc. | ||||
Verification Date | October 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |