Clinical trial NCT04700267: A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in biomarkers associated with disease anti-dsDNA
timeFrame: Between Day 1 and 104
measure: Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)
timeFrame: Between Day 1 and 104
measure: Number, incidence, and severity of treatment-emergent adverse events (TEAEs)
timeFrame: From screening through study completion, an average of 5 months
Secondary outcomes:
measure: Observed GLPG3970 plasma trough concentrations (Ctrough)
timeFrame: Between Day 1 and 87
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven
city: Plovdiv
country: Bulgaria
facility: UMHAT-Plovdiv AD
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski EAD
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Exploratory Medicine Phase I Unit
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Warszawa
country: Poland
facility: Medycyna Kliniczna
city: Wrocław
country: Poland
facility: FutureMeds sp. Z o. o.
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Kyiv
country: Ukraine
facility: Medical Centre of Ltd Liability Comp
city: Odesa
country: Ukraine
facility: Multidisciplinary Medical Center of Odesa National Medical University
city: Vinnytsia
country: Ukraine
facility: N.I.Pirogov Vinnytsia Reg Council
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabilitation
city: Zaporizhzhia
country: Ukraine
facility: LLC Suchasna klinika
Study officials:
affiliation: Galapagos NV
name: Catherine Vincent, MD
role: STUDY_DIRECTOR
References: