Trial · NCT03798366
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis
NCT03798366, Phase 2, Completed, Lakefront Biotherapeutics NV; results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis. Trials, record NCT03798366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03798366
On this page
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 Systemic Sclerosis
- NCT number
- NCT03798366
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Systemic Sclerosis
- Interventions
- GLPG1690, Placebo
- First posted
- 2019-01-09
- Last updated
- 2021-05-04
- Other registries' IDs
- eudract:2018-001817-33
- Results first posted
- 2021-05-04
- Limitations and caveats
- This was a proof-of-concept study not sized or powered to confirm any treatment effect.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in mRSS at Week 4 | Baseline, Week 4 | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. |
| Primary | Change From Baseline in mRSS at Week 8 | Baseline, Week 8 | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. |
| Primary | Change From Baseline in mRSS at Week 16 | Baseline, Week 16 | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. |
| Primary | Change From Baseline in mRSS at Week 24 | Baseline, Week 24 | The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to end of the study (36 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. |
Source ClinicalTrials.gov
Outcomes5
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 mRSS at Week 4 | Baseline, Week 4 | Participants in the FAS were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in mRSS at Week 8 | Baseline, Week 8 | Participants in the FAS were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in mRSS at Week 16 | Baseline, Week 16 | Participants in the FAS were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in mRSS at Week 24 | Baseline, Week 24 | Participants in the FAS were analyzed. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to end of the study (36 weeks) | Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
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 mRSS at Week 4 | GLPG1690 600 mg | -2.2 | Standard Error 0.85 | units on a scale | |
| Change From Baseline in mRSS at Week 4 | Placebo | -1.6 | Standard Error 1.04 | units on a scale | |
| Change From Baseline in mRSS at Week 8 | GLPG1690 600 mg | -3.2 | Standard Error 0.85 | units on a scale | |
| Change From Baseline in mRSS at Week 8 | Placebo | -2.5 | Standard Error 1.07 | units on a scale | |
| Change From Baseline in mRSS at Week 16 | GLPG1690 600 mg | -6.8 | Standard Error 0.85 | units on a scale | |
| Change From Baseline in mRSS at Week 16 | Placebo | -4.8 | Standard Error 1.12 | units on a scale | |
| Change From Baseline in mRSS at Week 24 | GLPG1690 600 mg | -8.9 | Standard Error 0.87 | units on a scale | |
| Change From Baseline in mRSS at Week 24 | Placebo | -6.0 | Standard Error 1.11 | units on a scale | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | GLPG1690 600 mg | TEAEs | 20 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Placebo | TEAEs | 11 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GLPG1690 600 mg | 21 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | GLPG1690 600 mg | 21 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | GLPG1690 600 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events200
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 | Upper respiratory tract infection | Infections and infestations | GLPG1690 600 mg | 2 | 21 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 2 | 12 | |
| other | Rhinitis | Infections and infestations | GLPG1690 600 mg | 2 | 21 | |
| other | Rhinitis | Infections and infestations | Placebo | 1 | 12 | |
| other | Urinary tract infection | Infections and infestations | GLPG1690 600 mg | 3 | 21 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 0 | 12 | |
| other | Cellulitis | Infections and infestations | GLPG1690 600 mg | 2 | 21 | |
| other | Cellulitis | Infections and infestations | Placebo | 0 | 12 | |
| other | Influenza | Infections and infestations | GLPG1690 600 mg | 2 | 21 | |
| other | Influenza | Infections and infestations | Placebo | 0 | 12 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse 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 | 12 |
| Total, other adverse events | GLPG1690 600 mg | 20 | 21 |
| Total, other adverse events | Placebo | 11 | 12 |
| Total, serious adverse events | GLPG1690 600 mg | 2 | 21 |
| Total, serious adverse events | Placebo | 1 | 12 |
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.
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/NCT03798366
GET https://conductscience.org/api/trials/v1/NCT03798366/events?page=2