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GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Sponsor
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04456998
Collaborator
(none)
86
Enrollment
65
Locations
2
Arms
25.6
Anticipated Duration (Months)
1.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: GB002 (seralutinib)
  • Drug: Placebo
  • Device: Generic Dry Powder Inhaler
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
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
Official Title:
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)
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: GB002 (seralutinib)

GB002 (seralutinib) inhaled orally twice per day (BID) over 24 weeks

Drug: GB002 (seralutinib)
Capsule containing GB002 (seralutinib)

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
Placebo Comparator: Placebo

Placebo inhaled orally BID over 24 weeks

Drug: Placebo
Matching capsule containing placebo

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) [Baseline, 24 weeks]

    Change in PVR using right heart catheterization (RHC)

Secondary Outcome Measures

  1. Change From Baseline to Week 24 on the Six-Minute Walk Test (6MWT) [Baseline, 24 weeks]

    Change in distance achieved on the 6MWT (Δ6MWD)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. A current diagnosis of symptomatic PAH classified by one of the following:

  2. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).

  3. PAH associated with connective tissue disease (CTD-APAH).

  4. PAH associated with anorexigen or methamphetamine use.

  5. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.

  6. 6MWD ≥ 150 meters and ≤ 550 meters at screening.

  7. WHO FC II or III symptomatology.

  8. Treatment with standard of care PAH background therapies.

  9. Documentation of cardiac catheterization within the screening period that is consistent with the diagnosis of PAH and meeting all the following criteria, to be confirmed by a central hemodynamic core laboratory:

  10. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest), AND

  11. PVR ≥ 400 dyne•sec/cm5, AND

  12. Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure (LVEDP) ≤12 mm Hg if PVR ≥400 to <500 dyne∙sec/cm5 OR

  13. PCWP or LVEDP ≤15 mmHg if PVR ≥500 dyne∙sec/cm5

  14. Pulmonary function tests (PFTs) at screening with the following criteria met:

  15. Forced expiratory volume in 1 second (FEV1) divided by the forced vital capacity (FVC) ≥70%;

  16. Total lung capacity (TLC) or FVC ≥ 70% predicted

Exclusion Criteria:

  1. Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram prior to screening.

  2. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during screening visit after a period of rest.

  3. Systolic blood pressure < 90 mm Hg during screening and baseline visits.

  4. WHO Pulmonary Hypertension Group 2-5.

  5. Human immunodeficiency virus (HIV)-associated PAH.

  6. History of left-sided heart disease and/or clinically significant cardiac disease.

  7. Untreated severe obstructive sleep apnea.

  8. History of atrial septostomy within 180 days prior to screening.

  9. Pulmonary venous occlusive disease (PVOD).

  10. Subjects with a history of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher; or baseline ALT or AST > 2 x ULN or Total Bilirubin ≥ 2 x ULN.

  11. History of malignancy within 5 years prior to screening.

  12. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.

  13. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg; history intracranial hemorrhage).

  14. Chronic renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-epi) at screening or requires dialytic therapy or hemofiltration.

  15. Hemoglobin (Hgb) concentration < 8.5 g/dL at screening.

  16. Evidence of active HIV, Hepatitis B or Hepatitis C, or tuberculosis (TB) infections.

  17. Inhaled prostanoids; these drugs may be withdrawn ≥ 4 weeks prior to or at screening, if clinically indicated.

  18. Use of oral anticoagulants (ie, warfarin or NOAC) at randomization.

  19. Requirement of intravenous (IV) inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) other than an IV prostanoid within 4 weeks of screening.

  20. Prior participation in GB002 studies and/or prior treatment with GB002.

  21. Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 4 weeks prior to screening.

  22. Current use of inhaled tobacco and/or inhaled marijuana.

  23. Current alcohol use disorder as defined by DSM-5 and/or positive test for drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).

  24. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.

  25. QTcF of > 480 msec recorded on a screening or baseline ECG or receiving concurrent treatment with medications that prolong QT interval.

  26. Have any other condition or reason that, in the opinion of the Investigator or Medical Monitor, would prohibit the subject from participating in the study.

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pulmonary Associates, PA Phoenix Arizona United States 85032
2 Dept of Veterans Affairs Greater Los Angeles Healthcare System Los Angeles California United States 90073
3 UC Davis Medical Center Sacramento California United States 95817
4 The University of California San Francisco San Francisco California United States 94143
5 Medical Corporation Santa Barbara California United States 93105
6 Stanford Healthcare Stanford California United States 94305
7 The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
8 Central Florida Pulmonary Group, PA Altamonte Springs Florida United States 32701
9 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
10 Cleveland Clinic Florida Weston Florida United States 33331
11 The Emory Clinic Atlanta Georgia United States 30322
12 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
13 University of Kansas Medical Center Kansas City Kansas United States 66160
14 Kentuckiana Pulmonary Research Center Louisville Kentucky United States 40202
15 Tufts Medical Center Boston Massachusetts United States 02111
16 Brigham and Women's Hospital Boston Massachusetts United States 02115
17 University of Michigan Ann Arbor Michigan United States 48109
18 University of Minnesota Minneapolis Minnesota United States 55455
19 Mayo Clinic Rochester Minnesota United States 55905
20 Washington University School of Medicine Saint Louis Missouri United States 63110
21 University of Nebraska Medical Center Omaha Nebraska United States 68198
22 University of New Mexico Health Sciences Center Albuquerque New Mexico United States 87131
23 NYU Langone Health New York New York United States 10016
24 New York Presbyterian Hospital - Weill Cornell Medicine New York New York United States 10065
25 University of Rochester Medical Center Rochester New York United States 14642
26 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
27 Cleveland Clinic Foundation Cleveland Ohio United States 44124
28 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
29 INTEGRIS Baptist Medical Center, Inc. Oklahoma City Oklahoma United States 73112
30 Oregon Health & Science University Portland Oregon United States 97239
31 Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104
32 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
33 UT Southwestern Medical Center Dallas Texas United States 75390
34 Houston Methodist Hospital Houston Texas United States 77030
35 University of Utah Health Salt Lake City Utah United States 84132
36 Medical College of Wisconsin - Froedtert Hospital Milwaukee Wisconsin United States 53226
37 St Vincent's Hospital Darlinghurst New South Wales Australia 2010
38 St Vincent's Hospital Melbourne Fitzroy Australia 3065
39 Royal Hobart Hospital Hobart Australia TAS 7000
40 Westmead Hospital Westmead Australia NSW 2145
41 LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin Graz Austria 8036
42 Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II Wien Austria 1090
43 Erasme University Hospital Bruxelles Belgium 1070
44 University Hospital of Leuven Leuven Belgium 3000
45 Sir Mortimer B Davis Jewish General Hospital Montréal Quebec Canada H3T 1E2
46 Peter Lougheed Centre Calgary Canada T1Y 6J4
47 London Health Sciences Centre - Victoria Hospital London Canada N6A 5W9
48 Všeobecná fakultní nemocnice v Praze Praha Czechia 128 08
49 AP-HP, Hopital de Bicetre Le Kremlin-Bicetre France 94270
50 CHRU de Lille - Hopital Claude Huriez Lille Cedex France 59037
51 CHU de Montpellier - Hopital Arnaud de Villeneuve Montpellier France 34295
52 Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545
53 DRK Kliniken Berlin - Westend Berlin Germany 14050
54 Universitätsklinikum Giessen / Marburg Gießen Germany 35392
55 Medizinische Hochschule Hannover Hannover Germany 30625
56 Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH Heidelberg Germany 69126
57 Universitatsklinikum des Saarlandes Klinik fur lnnere Medizin V Homburg/Saar Germany 66421
58 Universitatsklinikum Regensburg Regensburg Germany 93053
59 University Clinical Centre of Serbia Belgrade Serbia 11000
60 Institute for Pulmonary Diseases of Vojvodina Sremska Kamenica Serbia 21204
61 Hospital Universitario Vall d'Hebron Barcelona Spain 08035
62 Hospital Universitario 12 de Octubre Madrid Spain 28041
63 Hospital Universitario Marqués de Valdecilla Santander Spain 39008
64 Royal Papworth Hospital NHS Foundation Cambridge United Kingdom CB2 0AY
65 Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited London United Kingdom W12 OHS

Sponsors and Collaborators

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

Investigators

  • Study Director: Richard Aranda, Gossamer Bio Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier:
NCT04456998
Other Study ID Numbers:
  • GB002-2101
First Posted:
Jul 7, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
seralutinib
Additional relevant MeSH terms:
Pulmonary Arterial Hypertension
Hypertension

Study Results

No Results Posted as of Aug 18, 2022