Trial · NCT03976648

A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

NCT03976648, Phase 2, Terminated, Lakefront Biotherapeutics NV; results first posted 2022-03-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis. Trials, record NCT03976648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03976648

On this page

Trial

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

Title: A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
NCT number: NCT03976648
Status: Terminated
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: Lakefront Biotherapeutics NV
Conditions: Systemic Sclerosis
Interventions: GLPG1690
First posted: 2019-06-06
Last updated: 2022-03-29
Other registries' IDs: eudract:2019-001279-34
Results first posted: 2022-03-15
Limitations and caveats: The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Day 1 up to 91 weeks	An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Day 1 up to 91 weeks	Participants in the OLE-FAS were analyzed.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Category	Value	Units
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	GLPG1690 600 mg	TEAEs	21	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	TEAEs	10	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	GLPG1690 600 mg	Serious TEAEs	6	Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo	Serious TEAEs	3	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	GLPG1690 600 mg	21
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	GLPG1690 600 mg	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	GLPG1690 600 mg	21
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events198

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	Hot flush	Vascular disorders	GLPG1690 600 mg	0	21	0
other	Hot flush	Vascular disorders	Placebo	1	10	1
other	Raynaud's phenomenon	Vascular disorders	GLPG1690 600 mg	3	21	5
other	Raynaud's phenomenon	Vascular disorders	Placebo	0	10	0
other	Discomfort	General disorders	GLPG1690 600 mg	0	21	0
other	Discomfort	General disorders	Placebo	1	10	1
other	Nodule	General disorders	GLPG1690 600 mg	0	21	0
other	Nodule	General disorders	Placebo	1	10	1
other	Fatigue	General disorders	GLPG1690 600 mg	2	21	3
other	Fatigue	General disorders	Placebo	0	10	0

1 to 10 of 198Source ClinicalTrials.gov

See all 198 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GLPG1690 600 mg	0	21
Total, all-cause mortality	Placebo	0	10
Total, other adverse events	GLPG1690 600 mg	21	21
Total, other adverse events	Placebo	10	10
Total, serious adverse events	GLPG1690 600 mg	6	21
Total, serious adverse events	Placebo	3	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
GLPG1690 600 mg vs Placebo: deaths from any cause	Trial comparisons
GLPG1690 600 mg vs 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/NCT03976648

GET https://conductscience.org/api/trials/v1/NCT03976648/events?page=2

API reference For AI assistants