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

Systemic Lupus Erythematosus Clinical Trial

— TAPINOMA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04700267
• Other study ID #: GLPG3970-CL-102
• Secondary ID: 2020-001820-32
• Status: Terminated
• Phase: Phase 1
• Start date: December 28, 2020
• Est. completion date: October 6, 2021

Study information

• Verified date: October 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• GLPG3970 film-coated tablet
GLPG3970 for oral administration
• Placebo film-coated tablet
Placebo for oral administration

Locations

Country	Name	City	State
Bulgaria	Medical center Medconsult Pleven	Pleven
Bulgaria	UMHAT-Plovdiv AD	Plovdiv
Bulgaria	UMHAT Sv. Ivan Rilski EAD	Sofia
Moldova, Republic of	ARENSIA Exploratory Medicine Phase I Unit	Chisinau
Poland	Szpital Uniwersytecki nr 2 im.dr J. Biziela	Bydgoszcz
Poland	Centrum Medyczne Plejady	Kraków
Poland	Medycyna Kliniczna	Warszawa
Poland	FutureMeds sp. Z o. o.	Wroclaw
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Ukraine	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

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Bulgaria,  Moldova, Republic of,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers associated with disease anti-dsDNA	To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE	Between Day 1 and 104
Primary	Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)	To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE	Between Day 1 and 104
Primary	Number, incidence, and severity of treatment-emergent adverse events (TEAEs)	To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE	From screening through study completion, an average of 5 months
Secondary	Observed GLPG3970 plasma trough concentrations (Ctrough)	To characterize the PK of GLPG3970 in adult subjects with active SLE	Between Day 1 and 87