NCT04700280Phase 2Terminated

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (pSS)

Study sponsor: Lakefront Biotherapeutics NV · LKFT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-10-28Actual

Enrollment · participants31Actual

Source updated2023-09-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Primary Sjögren Syndrome

Treatments or interventions studied

GLPG3970Drug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 12; description: 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).; timeFrame: Baseline, Week 12; measure: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) by Severity; 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. 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.; timeFrame: From first dose of study drug up to 30 days after last dose of study drug (maximum duration=16 weeks)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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