Trial · NCT01769196

Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

NCT01769196, Phase 2, Terminated, Gilead Sciences; results first posted 2017-04-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT01769196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01769196

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
NCT number: NCT01769196
Status: Terminated
Phases: Phase 2
Enrollment: 544 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Simtuzumab, Simtuzumab placebo
First posted: 2013-01-16
Last updated: 2017-05-30
Other registries' IDs: eudract:2012-001571-36
Results first posted: 2017-04-13

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival	Up to 148 weeks	Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
Primary	PFS Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 148 weeks
Primary	PFS Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 148 weeks
Secondary	Overall Survival (OS)	Up to 151 weeks	Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Secondary	Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 151 weeks
Secondary	Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 151 weeks
Secondary	Relative Change From Baseline in FVC % Predicted	Weeks 54, 106, and 130	* FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. * Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130 * The relative change was calculated as 100% \* ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Secondary	Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations	Up to 148 weeks
Secondary	Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations	Up to 148 weeks
Secondary	Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death	Up to 148 weeks

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	Up to 148 weeks	ITT Analysis Set	months	MEDIAN
PRIMARY	PFS Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 148 weeks	Participants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.	months	MEDIAN
PRIMARY	PFS Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 148 weeks	Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.	months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to 151 weeks	ITT Analysis Set	months	MEDIAN
SECONDARY	Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	Up to 151 weeks	Participants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.	months	MEDIAN
SECONDARY	Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile	Up to 151 weeks	Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.	months	MEDIAN
SECONDARY	Relative Change From Baseline in FVC % Predicted	Weeks 54, 106, and 130	Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.	Percent change in FVC % predicted	LEAST_SQUARES_MEAN
SECONDARY	Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations	Up to 148 weeks	Participants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations	Up to 148 weeks	Participants in ITT Analysis Set with total hospitalizations were analyzed.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death	Up to 148 weeks	Participants in the ITT Analysis Set with adjudicated deaths were analyzed.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival	Simtuzumab	12.6	95% Confidence Interval 11.3 to 14.4	months
Progression Free Survival	Simtuzumab Placebo	15.4	95% Confidence Interval 12.6 to 19.1	months
PFS Among the Participants With sLOXL2 ≥ 50th Percentile	Simtuzumab	11.7	95% Confidence Interval 9.9 to 15.9	months
PFS Among the Participants With sLOXL2 ≥ 50th Percentile	Simtuzumab Placebo	14.3	95% Confidence Interval 10.4 to 19.1	months
PFS Among the Participants With sLOXL2 ≥ 75th Percentile	Simtuzumab	11.6	95% Confidence Interval 9.0 to 15.0	months
PFS Among the Participants With sLOXL2 ≥ 75th Percentile	Simtuzumab Placebo	16.9	95% Confidence Interval 7.7 to 21.7	months
Overall Survival (OS)	Simtuzumab	NA	95% Confidence Interval NA to NA	months
Overall Survival (OS)	Simtuzumab Placebo	NA	95% Confidence Interval NA to NA	months
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	Simtuzumab	NA	95% Confidence Interval NA to NA	months
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	Simtuzumab Placebo	NA	95% Confidence Interval NA to NA	months

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Simtuzumab	272
Overall Study	STARTED	Simtuzumab Placebo	272
Overall Study	COMPLETED	Simtuzumab	0
Overall Study	COMPLETED	Simtuzumab Placebo	0
Overall Study	NOT COMPLETED	Simtuzumab	272
Overall Study	NOT COMPLETED	Simtuzumab Placebo	272

Source ClinicalTrials.gov

Adverse events376

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Simtuzumab	16	271
other	Constipation	Gastrointestinal disorders	Simtuzumab Placebo	13	272
other	Diarrhoea	Gastrointestinal disorders	Simtuzumab	44	271
other	Diarrhoea	Gastrointestinal disorders	Simtuzumab Placebo	47	272
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Simtuzumab	21	271
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Simtuzumab Placebo	22	272
other	Nausea	Gastrointestinal disorders	Simtuzumab	33	271
other	Nausea	Gastrointestinal disorders	Simtuzumab Placebo	35	272
other	Asthenia	General disorders	Simtuzumab	15	271
other	Asthenia	General disorders	Simtuzumab Placebo	17	272

1 to 10 of 376Source ClinicalTrials.gov

See all 376 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Simtuzumab	31	271
Total, all-cause mortality	Simtuzumab Placebo	32	272
Total, other adverse events	Simtuzumab	237	271
Total, other adverse events	Simtuzumab Placebo	246	272
Total, serious adverse events	Simtuzumab	101	271
Total, serious adverse events	Simtuzumab Placebo	97	272

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27939076	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Simtuzumab vs Simtuzumab Placebo: Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations	Trial comparisons
Simtuzumab vs Simtuzumab Placebo: Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations	Trial comparisons
Simtuzumab vs Simtuzumab Placebo: Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death	Trial comparisons
Simtuzumab vs Simtuzumab Placebo: deaths from any cause	Trial comparisons
Simtuzumab vs Simtuzumab Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01769196

GET https://conductscience.org/api/trials/v1/NCT01769196/results?page=2

API reference For AI assistants