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

Primary Purpose

Systemic Lupus Erythematosus

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

GLPG3970 film-coated tablet

Placebo film-coated tablet

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical center Medconsult Pleven
UMHAT-Plovdiv AD
UMHAT Sv. Ivan Rilski EAD
ARENSIA Exploratory Medicine Phase I Unit
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Centrum Medyczne Plejady
Medycyna Kliniczna
FutureMeds sp. Z o. o.
Hospital de la Santa Creu i Sant Pau
Medical Centre of Ltd Liability Comp
Multidisciplinary Medical Center of Odesa National Medical University
N.I.Pirogov Vinnytsia Reg Council
SRI of Invalid Rehabilitation
LLC Suchasna klinika

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLPG3970

Placebo

Arm Description

One dose level of GLPG3970

One dose level of Placebo

Outcomes

Primary Outcome Measures

Change in biomarkers associated with disease anti-dsDNA

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)

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)

To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE

Secondary Outcome Measures

Observed GLPG3970 plasma trough concentrations (Ctrough)

To characterize the PK of GLPG3970 in adult subjects with active SLE

Full Information

NCT ID

NCT04700267

First Posted

January 6, 2021

Last Updated

October 14, 2021

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT04700267

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Study stopped on business grounds

Study Start Date

December 28, 2020 (Actual)

Primary Completion Date

October 6, 2021 (Actual)

Study Completion Date

October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLPG3970

Arm Type

Experimental

Arm Description

One dose level of GLPG3970

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

One dose level of Placebo

Intervention Type

Drug

Intervention Name(s)

GLPG3970 film-coated tablet

Intervention Description

GLPG3970 for oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo film-coated tablet

Intervention Description

Placebo for oral administration

Primary Outcome Measure Information:

Title

Change in biomarkers associated with disease anti-dsDNA

Description

To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE

Time Frame

Between Day 1 and 104

Title

Change in biomarkers associated with disease complement component 3 (C3), and complement component 4 (C4)

Description

To characterize the PD of GLPG3970 compared to placebo in adult subjects with active SLE

Time Frame

Between Day 1 and 104

Title

Number, incidence, and severity of treatment-emergent adverse events (TEAEs)

Description

To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult subjects with active SLE

Time Frame

From screening through study completion, an average of 5 months

Secondary Outcome Measure Information:

Title

Observed GLPG3970 plasma trough concentrations (Ctrough)

Description

To characterize the PK of GLPG3970 in adult subjects with active SLE

Time Frame

Between Day 1 and 87

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Vincent, MD

Organizational Affiliation

Galapagos NV

Official's Role

Study Director

Facility Information:

Facility Name

Medical center Medconsult Pleven

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

UMHAT-Plovdiv AD

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

UMHAT Sv. Ivan Rilski EAD

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

ARENSIA Exploratory Medicine Phase I Unit

City

Chisinau

ZIP/Postal Code

2025

Country

Moldova, Republic of

Facility Name

Szpital Uniwersytecki nr 2 im.dr J. Biziela

City

Bydgoszcz

ZIP/Postal Code

85168

Country

Poland

Facility Name

Centrum Medyczne Plejady

City

Kraków

ZIP/Postal Code

30363

Country

Poland

Facility Name

Medycyna Kliniczna

City

Warszawa

ZIP/Postal Code

00874

Country

Poland

Facility Name

FutureMeds sp. Z o. o.

City

Wrocław

ZIP/Postal Code

50088

Country

Poland

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

8041

Country

Spain

Facility Name

Medical Centre of Ltd Liability Comp

City

Kyiv

ZIP/Postal Code

01135

Country

Ukraine

Facility Name

Multidisciplinary Medical Center of Odesa National Medical University

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

N.I.Pirogov Vinnytsia Reg Council

City

Vinnytsia

ZIP/Postal Code

21028

Country

Ukraine

Facility Name

SRI of Invalid Rehabilitation

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

LLC Suchasna klinika

City

Zaporizhzhia

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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