A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus

Phase 1

Terminated

Interventions: Drug: GLPG3970 film-coated tablet
Drug: Placebo film-coated tablet

Brief Summary: This is a first exploration of GLPG3970 in subjects with active systemic lupus erythematosus (SLE) to evaluate the effect on disease biomarkers and to determine its pharmacokinetics (PK) profile, safety and tolerability, and pharmacodynamics (PD) biomarkers related to the investigational product (IP) mechanism of action and the pathophysiology of SLE.

Recruitment & Eligibility

Inclusion Criteria

SLE diagnosis defined by American College of Rheumatology (ACR) 1997 criteria ≥4
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))

This list only contains the key inclusion criteria.

Exclusion Criteria

Lupus nephritis >= Class III
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

This list only contains the key exclusion criteria.

Arm && Interventions

Group	Intervention	Description
GLPG3970	GLPG3970 film-coated tablet	One dose level of GLPG3970
Placebo	Placebo film-coated tablet	One dose level of Placebo

Primary Outcome Measures

Name	Time	Method
Change in biomarkers associated with disease anti-dsDNA	Between Day 1 and 104	To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)	Between Day 1 and 104	To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE
Number, incidence, and severity of treatment-emergent adverse events (TEAEs)	From screening through study completion, an average of 5 months	To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE

Secondary Outcome Measures

Name	Time	Method
Observed GLPG3970 plasma trough concentrations (Ctrough)	Between Day 1 and 87	To characterize the PK of GLPG3970 in adult subjects with active SLE

Locations (14): Hospital de la Santa Creu i Sant Pau
🇪🇸
Barcelona, Spain
Medycyna Kliniczna
🇵🇱
Warszawa, Poland
Medical Centre of Ltd Liability Comp
🇺🇦
Kyiv, Ukraine
ARENSIA Exploratory Medicine Phase I Unit
🇲🇩
Chisinau, Moldova, Republic of
Medical center Medconsult Pleven
🇧🇬
Pleven, Bulgaria
UMHAT Sv. Ivan Rilski EAD
🇧🇬
Sofia, Bulgaria
SRI of Invalid Rehabilitation
🇺🇦
Vinnytsia, Ukraine
LLC Suchasna klinika
🇺🇦
Zaporizhzhia, Ukraine
UMHAT-Plovdiv AD
🇧🇬
Plovdiv, Bulgaria
Centrum Medyczne Plejady
🇵🇱
Kraków, Poland
FutureMeds sp. Z o. o.
🇵🇱
Wrocław, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
🇵🇱
Bydgoszcz, Poland
Multidisciplinary Medical Center of Odesa National Medical University
🇺🇦
Odesa, Ukraine
N.I.Pirogov Vinnytsia Reg Council
🇺🇦
Vinnytsia, Ukraine