18 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Safety Profile of SimtuzumabPrimary· 30 days post last study treatment (up to 165 weeks)
The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
Adverse Events (AEs)
Group
Value
95% CI
Simtuzumab
97.1
Grade 3 or 4 AEs
Group
Value
95% CI
Simtuzumab
47.1
Serious Adverse Events
Group
Value
95% CI
Simtuzumab
35.3
SAEs Related to simtuzumab
Group
Value
95% CI
Simtuzumab
5.9
AEs leading to discontinuation of simtuzumab
Group
Value
95% CI
Simtuzumab
29.4
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144Secondary· Weeks 72 and 144
* FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
* Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.
Week 72
Group
Value
95% CI
Simtuzumab
-8.05
± 1.829
Week 144
Group
Value
95% CI
Simtuzumab
-12.04
± 2.086
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144Secondary· Weeks 72 and 144
* DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
* Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.
Week 72
Group
Value
95% CI
Simtuzumab
-7.41
± 3.062
Week 144
Group
Value
95% CI
Simtuzumab
-22.80
± 3.475
All-cause MortalitySecondary· Up to 165 weeks
All-cause mortality was assessed as a number of participants who died from any cause.
Group
Value
95% CI
Simtuzumab
3
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120Secondary· Weeks 72 and 120
Week 72
Group
Value
95% CI
Simtuzumab
5.93
± 5.937
Week 120
Group
Value
95% CI
Simtuzumab
-0.69
± 6.032
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days post last study treatment (up to 165 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Simtuzumab
Serious: 12/34 (35%)
Deaths: 3/34
Serious adverse events (20 terms)
Reaction
System
Simtuzumab
Pneumonia
Infections and infestations
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Leukocytosis
Blood and lymphatic system disorders
—
Arteriosclerosis coronary artery
Cardiac disorders
—
Coronary artery disease
Cardiac disorders
—
Coronary artery occlusion
Cardiac disorders
—
Myocardial infarction
Cardiac disorders
—
Hiatus hernia
Gastrointestinal disorders
—
Chest pain
General disorders
—
Influenza
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
—
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01672853 — Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (P
· Phase 2
· completed
NCT01769196 — Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 2
· terminated
NCT01707472 — Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
· Phase 2
· completed
NCT01369498 — Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelo
· Phase 2
· completed
Other recruiting trials for Idiopathic Pulmonary Fibrosis
Currently open trials in the same condition.
NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF
· Phase 1
· recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in
· Phase 2
· recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc
· Phase 1
· recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
· Phase 2
· recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o
· Phase 1
· recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 4 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01759511.