CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
GB002 (seralutinib) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04456998
NCT04456998Phase 2Completed
CompareCT.gov

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)

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.·interventional·Posted Jul 7, 2020·Updated Nov 7, 2023

In Brief

A Phase 2 clinical trial evaluating GB002 (seralutinib), Placebo, and 1 other intervention for Pulmonary Artery Hypertension. Completed, enrolled 86 participants across 63 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Artery Hypertension
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Serbia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartNov 12, 2020
Primary CompletionOct 17, 2022
Study CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.0 years ago

Interventions

GB002 (seralutinib)drug

Capsule containing GB002 (seralutinib)

Placebodrug

Matching capsule containing placebo

Generic Dry Powder Inhalerdevice

Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery