Systemic Sclerosis
Conditions
Brief summary
This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.
Interventions
DRUGGLPG1690
film-coated tablets of GLPG1690 to be administered orally
Sponsors
Galapagos NV
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants who completed the 24-week treatment period of Study GLPG1690-CL-204 and who according to the investigator's judgment may benefit from long-term treatment with GLPG1690.
Exclusion criteria
* Any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Belgium, Italy, Spain, the United Kingdom, and the United States. The first participant was screened on 18 Jul 2019. The last study visit occurred on 13 Apr 2021. The treatment duration was planned for 104 weeks but the study was terminated at 91 weeks.
Pre-assignment details
A total of 31 participants who completed 24-week double-blind treatment in the GLPG1690-CL-204 (NCT03798366) study were rolled over and randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| GLPG1690 600 mg Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 21 |
| Placebo Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 10 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Study terminated by sponsor | 21 | 8 |
Baseline characteristics
| Characteristic | Placebo | Total | GLPG1690 600 mg |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 18.57 | 50.1 years STANDARD_DEVIATION 15.06 | 50.4 years STANDARD_DEVIATION 13.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 30 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 30 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 21 Participants | 15 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 10 |
| other Total, other adverse events | 21 / 21 | 10 / 10 |
| serious Total, serious adverse events | 6 / 21 | 3 / 10 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
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.
Time frame: Day 1 up to 91 weeks
Population: Participants in the OLE-FAS were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLPG1690 600 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 21 Participants |
| GLPG1690 600 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 6 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 10 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 3 Participants |