Trial · NCT01766817
Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
NCT01766817, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2019-05-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis. Trials, record NCT01766817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01766817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis
- NCT number
- NCT01766817
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 325 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- BMS-986020, Placebo matching with BMS-986020
- First posted
- 2013-01-11
- Last updated
- 2020-08-11
- Results first posted
- 2019-05-22
- Limitations and caveats
Due to 3 SAE cases on active treatment, a decision was taken by the sponsor to immediately discontinue all study dosing and to implement additional post-treatment safety monitoring in the off-treatment follow-up period.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | Baseline, Week 26 | FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes. |
| Secondary | Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | Baseline, Week 26 | The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller geometric mean ratios to baseline were considered favorable. Baseline included all testing done on Day -1 as well as predose on Day 1. |
| Secondary | Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | Baseline, Week 26 | The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities. Baseline included all testing done on Day -1 as well as predose on Day 1 |
| Secondary | Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26 | Baseline, Week 26 | The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. Baseline included all testing done on Day -1 as well as predose on Day 1. The total score ranges from 0 to 120, with higher scores indicating worse dyspnea. |
| Secondary | Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26 | Baseline, Week 26 | FVC is is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of lungs after taking an inhaled bronchodilator medicine which is used to dilate bronchial (breathing) tubes. Baseline included all testing done on Day -1 as well as predose on Day 1 |
| Secondary | Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26 | Baseline, Week 26 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the Aggregate Physical score of the SF-36. Items 5-8 primarily contribute to the Aggregate mental score of the SF-36. Scores on each item are summed and averaged. Range for Aggregate Physical Score : 0=worst to 100=best; and for Aggregate Mental Score: 0=worst to 100=best. Increases from baseline indicate improvement. Baseline included all testing done on Day -1 as well as predose on Day 1 |
| Secondary | Number of Participants With Death or Non-Elective Hospitalization | Upto Day 210 | Time to death or non-elective hospitalization was defined as the elapsed time (days) from randomization to the date of death or the first non-elective hospitalization. |
| Secondary | Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD) | Upto Day 210 | Number of participants with death or respiratory hospitalization or 10% decline in absolute volume of FVC or 25 meter loss in 6MWD over time were reported. |
| Secondary | Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26 | Baseline, Week 26 | DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine how much of the tracer gas was absorbed during the breath. DLCO, both uncorrected and corrected for hemoglobin in milliliter per minute per millimeter of mercury (mL/min/mmHg) was assessed. |
| Secondary | Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF) | Upto Day 210 | Acute IPF exacerbations is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated as definite (\>=1 AEx) and Probable. Investigators were asked to make the diagnosis of acute exacerbation of IPF on the basis of subjective worsening over 30 days or less, new bilateral radiographic opacities, and the absence of infection or another identifiable etiology. The final diagnosis, however, was confirmed by the study medical monitor. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | Baseline, Week 26 | Intent-to-treat (ITT) population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | liters (L) | MEAN |
| SECONDARY | Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | Ratio | NUMBER |
| SECONDARY | Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | meters (m) | MEAN |
| SECONDARY | Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | Unit on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | liters | MEAN |
| SECONDARY | Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for each category. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Death or Non-Elective Hospitalization | Upto Day 210 | Safety population included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD) | Upto Day 210 | Safety Population included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants.Here 'n' 'number analyzed' signifies number of participants who were evaluable for each category. | mL/min/mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF) | Upto Day 210 | ITT population included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | BMS-986020 600 mg Once Daily | -0.076 | Standard Deviation 0.2238 | liters (L) | |
| Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | BMS-986020 600 mg Twice Daily | -0.050 | Standard Deviation 0.2440 | liters (L) | |
| Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | Placebo | -0.136 | Standard Deviation 0.1804 | liters (L) | |
| Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | BMS-986020 600 mg Once Daily | 1.14 | Ratio | ||
| Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | BMS-986020 600 mg Twice Daily | 1.09 | Ratio | ||
| Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | Placebo | 1.11 | Ratio | ||
| Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | BMS-986020 600 mg Once Daily | -14.2 | Standard Deviation 47.85 | meters (m) | |
| Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | BMS-986020 600 mg Twice Daily | 6.1 | Standard Deviation 53.87 | meters (m) | |
| Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | Placebo | 10.3 | Standard Deviation 54.73 | meters (m) | |
| Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26 | BMS-986020 600 mg Once Daily | 3.8 | Standard Deviation 17.84 | Unit on a scale |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BMS-986020 600 mg Once Daily | 48 | |
| Overall Study | STARTED | BMS-986020 600 mg Twice Daily | 48 | |
| Overall Study | STARTED | Placebo | 47 | |
| Overall Study | COMPLETED | BMS-986020 600 mg Once Daily | 37 | |
| Overall Study | COMPLETED | BMS-986020 600 mg Twice Daily | 37 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | BMS-986020 600 mg Once Daily | 11 | |
| Overall Study | NOT COMPLETED | BMS-986020 600 mg Twice Daily | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 13 |
Source ClinicalTrials.gov
Adverse events138
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | BMS-986020 600 mg Once Daily | 3 | 48 | |
| other | Abdominal pain | Gastrointestinal disorders | BMS-986020 600 mg Twice Daily | 0 | 48 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 47 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | BMS-986020 600 mg Once Daily | 2 | 48 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | BMS-986020 600 mg Twice Daily | 3 | 48 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 2 | 47 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BMS-986020 600 mg Once Daily | 3 | 48 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BMS-986020 600 mg Twice Daily | 6 | 48 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 47 | |
| other | Blood alkaline phosphatase increased | Investigations | BMS-986020 600 mg Once Daily | 1 | 48 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986020 600 mg Once Daily | 2 | 48 |
| Total, all-cause mortality | BMS-986020 600 mg Twice Daily | 2 | 48 |
| Total, all-cause mortality | Placebo | 1 | 47 |
| Total, other adverse events | BMS-986020 600 mg Once Daily | 21 | 48 |
| Total, other adverse events | BMS-986020 600 mg Twice Daily | 40 | 48 |
| Total, other adverse events | Placebo | 25 | 47 |
| Total, serious adverse events | BMS-986020 600 mg Once Daily | 9 | 48 |
| Total, serious adverse events | BMS-986020 600 mg Twice Daily | 16 | 48 |
| Total, serious adverse events | Placebo | 12 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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
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