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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03976648
Recruitment Status : Terminated (The benefit-risk profile no longer supports continuing the studies)
First Posted : June 6, 2019
Results First Posted : March 15, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: GLPG1690 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2019
Actual Primary Completion Date : April 13, 2021
Actual Study Completion Date : April 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: GLPG1690 600 mg
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.
Drug: GLPG1690
film-coated tablets of GLPG1690 to be administered orally

Experimental: 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.
Drug: GLPG1690
film-coated tablets of GLPG1690 to be administered orally




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976648


Locations
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United States, California
Pacific Arthritis Care Center
Los Angeles, California, United States, 90045
UCLA Rheumatology
Los Angeles, California, United States, 90095
United States, Florida
RASF Clinical Research Center
Boca Raton, Florida, United States, 33486
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
UT Physicians Center for Autoimmunity
Houston, Texas, United States, 77030
Belgium
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Italy
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50139
Ospedale San Raffaele S.r.l. - PPDS
Milano, Italy, 20132
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 8035
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
United Kingdom
University Hospital Aintree
Liverpool, United Kingdom, L9 7AL
Royal Free Hospital
London, United Kingdom, NW32QG
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Galapagos Study Director Galapagos NV
  Study Documents (Full-Text)

Documents provided by Galapagos NV:
Study Protocol  [PDF] January 8, 2020
Statistical Analysis Plan  [PDF] April 13, 2021

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03976648    
Other Study ID Numbers: GLPG1690-CL-206
2019-001279-34 ( EudraCT Number )
First Posted: June 6, 2019    Key Record Dates
Results First Posted: March 15, 2022
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases