Trial · NCT03733444
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
NCT03733444, 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 Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care. Trials, record NCT03733444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03733444
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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 Participants With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
- NCT number
- NCT03733444
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 781 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- GLPG1690, Placebo
- First posted
- 2018-11-07
- Last updated
- 2022-07-29
- Other registries' IDs
- eudract:2018-001406-29
- Results first posted
- 2022-07-29
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 Forced Vital Capacity (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 52 Weeks | 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 125) | Percentage of participants with respiratory related to 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 of FVC Until EoS | Baseline up to EoS (week 125) | 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 125) | 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 125) | 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 125) | Percentage of participants with respiratory related mortality until end of study were reported for this study. |
| Secondary | Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS | Up to EoS (week 125) | Percentage of Participants who were hospitalized for 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 Forced Vital Capacity (FVC) up to Week 52 | Baseline up to week 52 | Full Analysis Set | mL/year | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Disease Progression Up to 52 Weeks | Up to week 52 | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Up to EoS (week 125) | Full Analysis Set | 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 | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Annual Rate of Decline of FVC Until EoS | Baseline up to EoS (week 125) | Full Analysis Set | mL/year | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Disease Progression Until EoS | Up to EoS (week 125) | Full Analysis Set | 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 | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With All Cause Hospitalization Until EoS | Up to EoS (week 125) | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Respiratory Related Mortality Until EoS | Up to EoS (week 125) | Full Analysis Set | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Hospitalized for Non-Elective Lung Transplant Until EoS | Up to EoS (week 125) | Full Analysis Set | Percentage of participants | NUMBER |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group167
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 Forced Vital Capacity (FVC) up to Week 52 | GLPG1690, 600 mg | -173.8 | Standard Error 18.04 | mL/year | |
| Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52 | GLPG1690, 200 mg | -174.9 | Standard Error 17.65 | mL/year | |
| Annual Rate of Decline in Forced Vital Capacity (FVC) up to Week 52 | Placebo | -176.6 | Standard Error 17.74 | mL/year | |
| Percentage of Participants With Disease Progression Up to 52 Weeks | GLPG1690, 600 mg | 23.9 | Percentage of participants | ||
| Percentage of Participants With Disease Progression Up to 52 Weeks | GLPG1690, 200 mg | 23.1 | Percentage of participants | ||
| Percentage of Participants With Disease Progression Up to 52 Weeks | Placebo | 22.1 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | GLPG1690, 600 mg | 13.5 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | GLPG1690, 200 mg | 10.8 | Percentage of participants | ||
| Percentage of Participants With Respiratory-Related Hospitalization Until End of Study (EoS) | Placebo | 6.6 | Percentage of participants | ||
| Change From Baseline in St.George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | GLPG1690, 600 mg | 4.6 | Standard Error 1.13 | Score on a scale |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 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 | 260 | |
| Overall Study | STARTED | GLPG1690, 200 mg | 262 | |
| Overall Study | STARTED | Placebo | 259 | |
| Overall Study | Treated | GLPG1690, 600 mg | 259 | |
| Overall Study | Treated | GLPG1690, 200 mg | 260 | |
| Overall Study | Treated | Placebo | 258 | |
| 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 | 260 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events393
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 | Weight decreased | Investigations | Placebo | 8 | 258 | 9 |
| other | Weight decreased | Investigations | GLPG1690, 600 mg | 14 | 259 | 16 |
| other | Weight decreased | Investigations | GLPG1690, 200 mg | 9 | 260 | 14 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 22 | 258 | 27 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | GLPG1690, 600 mg | 24 | 259 | 32 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | GLPG1690, 200 mg | 20 | 260 | 23 |
| other | Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Placebo | 14 | 258 | 17 |
| other | Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | GLPG1690, 600 mg | 24 | 259 | 34 |
| other | Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | GLPG1690, 200 mg | 18 | 260 | 21 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 22 | 258 | 25 |
1 to 10 of 393Source ClinicalTrials.gov
See all 393 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 12 | 258 |
| Total, all-cause mortality | GLPG1690, 600 mg | 23 | 259 |
| Total, all-cause mortality | GLPG1690, 200 mg | 21 | 260 |
| Total, other adverse events | Placebo | 117 | 258 |
| Total, other adverse events | GLPG1690, 600 mg | 141 | 259 |
| Total, other adverse events | GLPG1690, 200 mg | 134 | 260 |
| Total, serious adverse events | Placebo | 42 | 258 |
| Total, serious adverse events | GLPG1690, 600 mg | 64 | 259 |
| Total, serious adverse events | GLPG1690, 200 mg | 63 | 260 |
Source ClinicalTrials.gov
Papers4
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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