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

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

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.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: GLPG3970 film-coated tablet; Drug: Placebo film-coated tablet

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult Pleven
  • Plovdiv, Bulgaria, 4002
    • UMHAT-Plovdiv AD
  • Sofia, Bulgaria, 1612
    • Umhat Sv. Ivan Rilski Ead
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2025
    • ARENSIA Exploratory Medicine Phase I Unit
• Poland
  • Bydgoszcz, Poland, 85168
    • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Kraków, Poland, 30363
    • Centrum Medyczne Plejady
  • Warszawa, Poland, 00874
    • Medycyna Kliniczna
  • Wrocław, Poland, 50088
    • FutureMeds sp. z o. o.
• Spain
  • Barcelona, Spain, 8041
    • Hospital De La Santa Creu I Sant Pau
• Ukraine
  • Kyiv, Ukraine, 01135
    • Medical Centre of Ltd Liability Comp
  • Odesa, Ukraine, 65026
    • Multidisciplinary Medical Center of Odesa National Medical University
  • Vinnytsia, Ukraine, 21028
    • N.I.Pirogov Vinnytsia Reg Council
  • Vinnytsia, Ukraine, 21029
    • SRI of Invalid Rehabilitation
  • Zaporizhzhia, Ukraine, 69600
    • LLC Suchasna klinika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLPG3970; One dose level of GLPG3970	Drug: GLPG3970 film-coated tablet; GLPG3970 for oral administration
PLACEBO_COMPARATOR: Placebo; One dose level of Placebo	Drug: Placebo film-coated tablet; Placebo for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Catherine Vincent, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2020
• Primary Completion (ACTUAL): October 6, 2021
• Study Completion (ACTUAL): October 6, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: GLPG3970-CL-102; 2020-001820-32 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No