Back to resultsA Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Primary Purpose
Systemic Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLPG1690
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Pacific Arthritis Care Center
- UCLA Rheumatology
- RASF Clinical Research Center
- University of Michigan
- Metroplex Clinical Research Center
- UT Physicians Center for Autoimmunity
- UZ Gent
- UZ Leuven
- Azienda Ospedaliero Universitaria Careggi
- Ospedale San Raffaele S.r.l. - PPDS
- Hospital Universitario Vall d'Hebron
- Hospital Universitario 12 de Octubre
- University Hospital Aintree
- Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GLPG1690 600 mg
Placebo
Arm Description
Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03976648
Brief Title
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Official Title
A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The benefit-risk profile no longer supports continuing the studies
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLPG1690 600 mg
Arm Type
Experimental
Arm Description
Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GLPG1690
Intervention Description
film-coated tablets of GLPG1690 to be administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Arthritis Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
UCLA Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
RASF Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UT Physicians Center for Autoimmunity
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l. - PPDS
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
University Hospital Aintree
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW32QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
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