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

NCT04700267 | Terminated Phase 1 DMC

• 2 other identifiers: GLPG3970-CL-1022020-001820-32
• Study Type: interventional
• Target: 11
• Locations: 5 countries
• Sites: 14

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Observed GLPG3970 plasma trough concentrations (Ctrough)

  Between Day 1 and 87

Study Arms (2)

GLPG3970

EXPERIMENTAL

One dose level of GLPG3970

Drug: GLPG3970 film-coated tablet

Placebo

PLACEBO COMPARATOR

One dose level of Placebo

Drug: Placebo film-coated tablet

Interventions

GLPG3970 film-coated tablet DRUG

GLPG3970 for oral administration

GLPG3970

Placebo film-coated tablet DRUG

Placebo for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (14)

Medical center Medconsult Pleven

Pleven, 5800, Bulgaria

Location

UMHAT-Plovdiv AD

Plovdiv, 4002, Bulgaria

Location

UMHAT Sv. Ivan Rilski EAD

Sofia, 1612, Bulgaria

Location

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, 2025, Moldova

Location

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, 85168, Poland

Location

Centrum Medyczne Plejady

Krakow, 30363, Poland

Location

Medycyna Kliniczna

Warsaw, 00874, Poland

Location

FutureMeds sp. Z o. o.

Wroclaw, 50088, Poland

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Medical Centre of Ltd Liability Comp

Kyiv, 01135, Ukraine

Location

Multidisciplinary Medical Center of Odesa National Medical University

Odesa, 65026, Ukraine

Location

N.I.Pirogov Vinnytsia Reg Council

Vinnytsia, 21028, Ukraine

Location

SRI of Invalid Rehabilitation

Vinnytsia, 21029, Ukraine

Location

LLC Suchasna klinika

Zaporizhzhia, 69600, Ukraine

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Catherine Vincent, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: December 28, 2020
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); UA (5); MO (1); PL (4); BU (3)