Trial · NCT03711162
A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
NCT03711162, Phase 3, Terminated, Lakefront Biotherapeutics NV; results first posted 2022-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care. Trials, record NCT03711162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03711162
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
- NCT number
- NCT03711162
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 525 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- GLPG1690, Placebo
- First posted
- 2018-10-18
- Last updated
- 2022-07-29
- Other registries' IDs
- eudract:2018-001405-87
- Results first posted
- 2022-07-29
- Limitations and caveats
- This Study was prematurely terminated based on recommendations of the Independent Data Monitoring Committee.
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Rate of Decline in FVC up to Week 52 | Baseline up to week 52 | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Disease Progression up to Week 52 | Up to week 52 | Disease progression was defined as the composite occurrence of more than or equal to (\>=)10 percent (%) absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Up to EoS (week 121) | Percentage of participants with respiratory related hospitalization were reported in this measure. |
| Secondary | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline, week 52 | SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 \* summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 \* summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. |
| Secondary | Annual Rate of Decline in FVC Until EoS | Baseline up to EoS (week 121) | FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Percentage of Participants With Disease Progression Until EoS | Up to EoS (week 121) | Disease progression was defined as the composite occurrence of \>=10% absolute decline in percent predicted %FVC or all-cause mortality. FVC (in mL) is the maximum amount of air exhaled from lungs by a participant after taking their deepest possible breath, as measured by spirometry. |
| Secondary | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100 | Baseline, week 100 | SGRQ is a 50-item paper questionnaire designed to measure and quantify the impact of chronic respiratory disease on health-related quality of life (QOL) and well-being, split into 3 domains: symptoms score assessing the frequency and severity of respiratory symptoms (Items 1-8), activity score assessing the effects of breathlessness on mobility and physical activity (Items 11-17 and 36 to 44), and impacts score assessing the psychosocial impact of the disease (Items 9-10, 18-35 and 45-50). Each item has a specific weight. Domain scores = 100 \* summed weights from positive items in that component/sum of maximum weights for all non-missing items in that component Total score = 100 \* summed weights from positive items in the questionnaire/sum of maximum weights for all non-missing items in the questionnaire Scores were weighted such that each domain score ranged from 0 to 100 and the total score ranged from 0 to 100, with higher scores indicating the poorer health-related QOL. |
| Secondary | Percentage of Participants With All Cause Hospitalization Until EoS | Up to EoS (week 121) | Percentage of participants with all cause hospitalization was reported for this measure. |
| Secondary | Percentage of Participants With Respiratory Related Mortality Until EoS | Up to EoS (week 121) | Percentage of participants with respiratory related mortality until EoS were reported for this study. |
| Secondary | Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS | Up to EoS (week 121) | Percentage of Participants who were hospitalized for Non-elective lung transplant were reported for this measure. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Rate of Decline in FVC up to Week 52 | Baseline up to week 52 | Full Analysis Set - Efficacy (FAS-EF) included all randomized participants who received at least 1 dose of investigational product and excluded participants from the site found to have serious good clinical practice (GCP)-noncompliance issues. | mL/year | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Disease Progression up to Week 52 | Up to week 52 | Full Analysis Set- Efficacy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Up to EoS (week 121) | Full Analysis Set- Efficacy | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | Baseline, week 52 | Full Analysis Set- Efficacy | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Rate of Decline in FVC Until EoS | Baseline up to EoS (week 121) | Full Analysis Set - Efficacy | mL/year | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Disease Progression Until EoS | Up to EoS (week 121) | Full Analysis Set - Efficacy | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 100 | Baseline, week 100 | Full Analysis Set - Efficacy | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With All Cause Hospitalization Until EoS | Up to EoS (week 121) | Full Analysis Set - Efficacy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Respiratory Related Mortality Until EoS | Up to EoS (week 121) | Full Analysis Set - Efficacy | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Hospitalized for Non-elective Lung Transplant Until EoS | Up to EoS (week 121) | Full Analysis Set - Efficacy | Percentage of participants | NUMBER |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group161
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Rate of Decline in FVC up to Week 52 | GLPG1690 600 mg | -124.6 | Standard Error 27.15 | mL/year | |
| Annual Rate of Decline in FVC up to Week 52 | GLPG1690 200 mg | -173.9 | Standard Error 26.31 | mL/year | |
| Annual Rate of Decline in FVC up to Week 52 | Placebo | -147.3 | Standard Error 26.72 | mL/year | |
| Percentage of Participants With Disease Progression up to Week 52 | GLPG1690 600 mg | 17.8 | Percentage of participants | ||
| Percentage of Participants With Disease Progression up to Week 52 | GLPG1690 200 mg | 18.7 | Percentage of participants | ||
| Percentage of Participants With Disease Progression up to Week 52 | Placebo | 18.3 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | GLPG1690 600 mg | 9.5 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | GLPG1690 200 mg | 9.4 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Placebo | 9.8 | Percentage of participants | ||
| Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | GLPG1690 600 mg | 3.3 | Standard Error 1.41 | Score on a scale |
1 to 10 of 161Source ClinicalTrials.gov
See all 161 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GLPG1690 600 mg | 175 | |
| Overall Study | STARTED | GLPG1690 200 mg | 175 | |
| Overall Study | STARTED | Placebo | 175 | |
| Overall Study | Treated | GLPG1690 600 mg | 174 | |
| Overall Study | Treated | GLPG1690 200 mg | 175 | |
| Overall Study | Treated | Placebo | 174 | |
| Overall Study | COMPLETED | GLPG1690 600 mg | 0 | |
| Overall Study | COMPLETED | GLPG1690 200 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | GLPG1690 600 mg | 175 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events300
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 | Diarrhoea | Gastrointestinal disorders | GLPG1690 600 mg | 51 | 174 | 111 |
| other | Diarrhoea | Gastrointestinal disorders | GLPG1690 200 mg | 40 | 175 | 84 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 20 | 174 | 33 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | GLPG1690 600 mg | 9 | 174 | 10 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | GLPG1690 200 mg | 3 | 175 | 3 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 2 | 174 | 2 |
| other | Nausea | Gastrointestinal disorders | GLPG1690 600 mg | 16 | 174 | 18 |
| other | Nausea | Gastrointestinal disorders | GLPG1690 200 mg | 14 | 175 | 20 |
| other | Nausea | Gastrointestinal disorders | Placebo | 10 | 174 | 14 |
| other | Fatigue | General disorders | GLPG1690 600 mg | 10 | 174 | 10 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GLPG1690 600 mg | 12 | 174 |
| Total, all-cause mortality | GLPG1690 200 mg | 8 | 175 |
| Total, all-cause mortality | Placebo | 8 | 174 |
| Total, other adverse events | GLPG1690 600 mg | 91 | 174 |
| Total, other adverse events | GLPG1690 200 mg | 99 | 175 |
| Total, other adverse events | Placebo | 82 | 174 |
| Total, serious adverse events | GLPG1690 600 mg | 38 | 174 |
| Total, serious adverse events | GLPG1690 200 mg | 38 | 175 |
| Total, serious adverse events | Placebo | 36 | 174 |
Source ClinicalTrials.gov
Papers3
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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