This is a first exploration of GLPG3970 in participants with active primary Sjogren's Syndrome (pSS) to evaluate the efficacy, safety and tolerability and to determine its pharmacokinetics (PK) profile compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany
General Hospital of Athens Laiko
Athens, Greece
Debreceni Egyetem
Debrecen, Hungary
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland
Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 12
The ESSDAI is a systemic disease activity index to assess 12 domains (organ systems: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, CNS, hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, and high). Each domain score was obtained by multiplying the activity level with the domain weight, ranged from 1 to 6, and assigned a numerical score based on pre-determined weighting of each individual domain. The sum of all individual weighted domain scores was the overall score, ranged from 0 (best) to 123 (worst activity). A higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated the improvement of symptoms. Least squares (LS) mean was calculated using mixed models for repeated measures (MMRM).
Time frame: Baseline, Week 12
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity
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. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) current version at the time of assessment. The maximum intensity of the AE were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). A TEAE was any AE with an onset date on or after the first dose of GLPG3970 and no later than 30 days after last dose of GLPG3970, or any worsening of any AE on or after the GLPG3970 start date.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks)
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain was scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score was calculated as the mean of the 3 individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A higher score indicates worst symptom. A clinically significant reduction from baseline of the ESSPRI score (at least one point or 15% of the baseline value) indicated the improvement of symptoms.
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Centrum Medyczne Plejady
Krakow, Poland
ETG Lublin
Lublin, Poland
Centrum Badan Klinicznych S.C.
Poznan, Poland
Medycyna Kliniczna
Warsaw, Poland
NZOZ Centrum Medyczne Reuma Park
Warsaw, Poland
Medical Center Harmoniya Krasy
Kyiv, Ukraine
Time frame: Baseline, Weeks 4, 8, and 12
Change From Baseline in ESSDAI Score at Weeks 4, 8, and 12
The ESSDAI is a systemic disease activity index to assess 12 domains (organ systems: constitutional, lymphadenopathy and lymphoma, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, CNS, hematological, biological) in participants with pSS. Each of the domains was assessed for activity level (no, low, moderate, and high). Each domain score was obtained by multiplying the activity level with the domain weight, ranged from 1 to 6, and assigned a numerical score based on pre-determined weighting of each individual domain. The sum of all individual weighted domain scores was the overall score, ranged from 0 (best) to 123 (worst activity). A higher score indicated more disease activity. A clinically meaningful reduction from baseline (≥3 points) indicated the improvement of symptoms. Results of Week 12 is presented in primary outcome measure 1.
Time frame: Baseline, Weeks 4, 8, and 12
Observed Pre-dose Plasma Concentration (Ctrough) of GLPG3970
Plasma concentration of GLPG3970 observed at pre-dose in nanogram per milliliter (ng/mL), obtained directly from the observed concentration versus time data.
Time frame: Pre-dose (within 30 minutes prior to dosing) on Weeks 1, 4, 8, and 12