A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06317285 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2209292023-509371-16-002023
• Study Type: interventional
• Target: 158
• Locations: 10 countries
• Sites: 56

Brief Summary

Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

GSK3915393; Idiopathic Pulmonary Fibrosis; Efficacy; Safety; Forced vital capacity; Tolerability

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26

  Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline (CFB) in FVC at Week 26 was calculated for each participant using the FVC Week 26 result minus the Baseline FVC result. Posterior median CFB and the 95% highest posterior density (HPD) interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.

  Baseline (Day 1) and Week 26

Secondary Outcomes (12)

• Absolute Change From Baseline in Forced Vital Capacity at Weeks 4, 8, 12 and 18

  Baseline (Day 1) and Weeks 4, 8, 12 and 18

• Absolute Change From Baseline in FVC (Percentage [%] Predicted) at Weeks 4, 8, 12, 18 and 26

  Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26

• Proportion of Participants Who Achieved Relative Decline of Less Than or Equal to (<=) 5% in FVC From Baseline at Week 26

  Baseline (Day 1) and Week 26

• Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 29

• Number of Participants With Vital Signs Results by Potential Clinical Importance (PCI) Criteria

  Up to Week 29

Study Arms (2)

GSK3915393

EXPERIMENTAL

Participants received GSK3915393 80 milligrams (mg), orally, twice daily for 26 weeks.

Drug: GSK3915393

Placebo

PLACEBO COMPARATOR

Participants received matching placebo, orally, twice daily for 26 weeks.

Drug: Placebo

Interventions

GSK3915393 DRUG

GSK3915393 was administered.

GSK3915393

Placebo DRUG

Placebo was administered.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with IPF diagnosed within 5 years prior to screening based on the applicable American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guideline at the time of diagnosis.
• Centrally read chest High Resolution Computed Tomography (HRCT) obtained at screening or historical HRCT obtained within 12 months of screening that is consistent with Usual interstitial pneumonia (UIP) or probable UIP (if indeterminate HRCT finding, IPF may be confirmed locally by historical biopsy).
• FVC greater than or equal to (\>=) 45 percent (%) of predicted normal.
• Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) \>=25% of predicted normal corrected for hemoglobin (Hb).
• Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC \>=0.7.
• If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
• If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or participant choice.
• If not currently receiving pirfenidone or nintedanib, participant must have stopped pirfenidone or nintedanib for at least 4 weeks prior to screening.
• Body weight \>=40 kilogram (kg) and body mass index within the range 18.5-35 kilogram per meter square (kg/m\^2) (inclusive).
• A female participant is eligible to participate if a woman of nonchildbearing potential (WONCBP)
• Capable of giving signed informed consent

You may not qualify if:

• Participants with Interstitial Lung Disease (ILD) associated with other known causes.
• Diagnosis of sarcoidosis or any systemic autoimmune disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus and rheumatoid arthritis).
• Acute IPF exacerbation within 6 months prior to screening and/or during the screening period (investigator-determined).
• Clinically significant non-parenchymal lung disease (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural diseases) at screening.
• Diagnosis of severe pulmonary hypertension (investigator-determined)
• Extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
• History of previous lung transplant or recent major surgery (investigator-determined) within 12 weeks prior to screening or planned during the trial period. Registration on a transplant waiting list is allowed.
• Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, Corona virus disease 2019 \[COVID-19\]) requiring treatment within 4 weeks prior to and/or during the screening period.
• Cigarette smoking (including e-cigarettes) either current or within 3 months before screening.
• Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) greater than (\>) 2x Upper Limit of Normal (ULN) and bilirubin \>1.5x ULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than (\<) 35% at screening).
• Clinically significant abnormalities detected on ECG of either rhythm or conduction, a Corrected QT interval (QTc) \>450 millisecond (msec) or QTc \> 480msec for participants with a bundle branch block and/or a pacemaker who are actively ventricularly pacing during the screening ECG.
• Participants with pacemakers who are not pacing at the time of the screening ECG should have a non-paced QTc \<450 msec.
• Prior/Concomitant Therapy-
• Simultaneous use of pirfenidone and nintedanib at screening.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (56)

GSK Investigational Site

Newport Beach, California, 92663, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32224, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33704, United States

Location

GSK Investigational Site

Ann Arbor, Michigan, 48109-5360, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37204, United States

Location

GSK Investigational Site

Cypress, Texas, 77429, United States

Location

GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Bueno, C1207AAP, Argentina

Location

GSK Investigational Site

Florida, B1602DQD, Argentina

Location

GSK Investigational Site

La Plata, 1900, Argentina

Location

GSK Investigational Site

Mendoza, M5500CCG, Argentina

Location

GSK Investigational Site

Rosario, S2000DBS, Argentina

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GSK Investigational Site

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

Location

GSK Investigational Site

Hamilton, Ontario, L8N 4A6, Canada

Location

GSK Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

GSK Investigational Site

La Tronche, 38700, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Rennes, 35000, France

Location

GSK Investigational Site

Rouen, 76000, France

Location

GSK Investigational Site

Toulouse, 31059, France

Location

GSK Investigational Site

Essen, 45293, Germany

Location

GSK Investigational Site

Hanover, 30173, Germany

Location

GSK Investigational Site

Heidelberg, 69126, Germany

Location

GSK Investigational Site

Wuppertal, 42283, Germany

Location

GSK Investigational Site

Catania, 95123, Italy

Location

GSK Investigational Site

Monza MB, 20900, Italy

Location

GSK Investigational Site

Naples, Italy

Location

GSK Investigational Site

Padova, 35128, Italy

Location

GSK Investigational Site

Perugia, 06132, Italy

Location

GSK Investigational Site

Pisa, 56124, Italy

Location

GSK Investigational Site

Roma, 00168, Italy

Location

GSK Investigational Site

Sassari, 07100, Italy

Location

GSK Investigational Site

Torrette AN, Italy

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

Location

GSK Investigational Site

Bialystok, 15-044, Poland

Location

GSK Investigational Site

Lodz, 90-153, Poland

Location

GSK Investigational Site

Poznan, 60-569, Poland

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Barcelona, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Oviedo, 33011, Spain

Location

GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

Location

GSK Investigational Site

Santander, 39011, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Edinburgh, EH16 4SA, United Kingdom

Location

GSK Investigational Site

Leeds West Yorkshire, LS9 7TF, United Kingdom

Location

GSK Investigational Site

London, SW3 6HP, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study with respect to allocation of GSK3915393 or placebo to participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a placebo-controlled parallel group study.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: April 4, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 18, 2026
• Results First Posted: September 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

FR (6); DE (4); GB (3); PL (3); US (10); NL (2); ES (8); CA (5); AR (6); IT (9)