A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
NCT ID: NCT04700267
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2020-12-28
2021-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG3970
One dose level of GLPG3970
GLPG3970 film-coated tablet
GLPG3970 for oral administration
Placebo
One dose level of Placebo
Placebo film-coated tablet
Placebo for oral administration
Interventions
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GLPG3970 film-coated tablet
GLPG3970 for oral administration
Placebo film-coated tablet
Placebo for oral administration
Eligibility Criteria
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Inclusion Criteria
* Active arthritis in \>=4 active joints (according to 28 joint count) and/or cutaneous lupus erythematosus disease area and severity index (CLASI) score \>=6.
* Anti-dsDNA antibodies \>15 IU/mL.
* Stable standard-of-care (SoC) therapy (defined as no change in prescription for at least 2 weeks prior to first IP dosing) consisting of the following permitted SoC medications:
* Corticosteroids \<=20 mg/day (prednisone or equivalent) for at least 2 weeks prior to first IP dosing; AND/OR
* Non-steroidal anti-inflammatory drug (NSAIDs); AND/OR
* One single antimalarial at a stable dose (hydroxychloroquine \<=5 mg/ kg/day, quinacrine 100 mg/day, or chloroquine 2.3 mg/kg/day) for at least 8 weeks prior to first IP dosing; AND/OR
* One single immunosuppressant at a stable dose (azathioprine (AZA) \<=2 mg/kg/day, methotrexate (MTX) \<=20 mg/week, or mycophenolate mofetil (MMF) \<=2 g/day) for at least 8 weeks prior to first IP dosing.
* estimated glomerular filtration rate (eGFR) \>=60 mL/min (according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))
Exclusion Criteria
* Severe organ manifestation or life-threatening lupus disease (active severe central nervous system lupus, severe pleuro-pericarditis, severe vasculitis).
* Severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) infection \>0
* Unstable condition not related to SLE
* Systemic inflammatory condition other than SLE such as, but not limited to rheumatoid arthritis (RA), spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis
* Sjögren's syndrome and/or antiphospholipid antibody syndrome who do not require treatment with any prohibited medication are NOT excluded.
* Active systemic infection
* Poorly controlled chronic cardiac, pulmonary, or renal disease.
* Known or suspected history of or a current immunosuppressive condition, or a history of invasive opportunistic infections
* Treatment with disallowed therapies
18 Years
65 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Catherine Vincent, MD
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Medical center Medconsult Pleven
Pleven, , Bulgaria
UMHAT-Plovdiv AD
Plovdiv, , Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, , Bulgaria
ARENSIA Exploratory Medicine Phase I Unit
Chisinau, , Moldova
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Medycyna Kliniczna
Warsaw, , Poland
FutureMeds sp. Z o. o.
Wroclaw, , Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Medical Centre of Ltd Liability Comp
Kyiv, , Ukraine
Multidisciplinary Medical Center of Odesa National Medical University
Odesa, , Ukraine
N.I.Pirogov Vinnytsia Reg Council
Vinnytsia, , Ukraine
SRI of Invalid Rehabilitation
Vinnytsia, , Ukraine
LLC Suchasna klinika
Zaporizhzhia, , Ukraine
Countries
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Other Identifiers
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2020-001820-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG3970-CL-102
Identifier Type: -
Identifier Source: org_study_id