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GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

NCT04456998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-11-07

Study results available
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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.

Conditions

  • Pulmonary Artery Hypertension

Interventions

DRUG

GB002 (seralutinib)

Capsule containing GB002 (seralutinib)

DRUG

Placebo

Matching capsule containing placebo

DEVICE

Generic Dry Powder Inhaler

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

Sponsors & Collaborators

  • GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Aranda · Gossamer Bio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2022-10-17
Completion
2022-11-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456998 on ClinicalTrials.gov