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A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome (GLIDER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04700280
Recruitment Status : Terminated (Study was terminated based on Sponsor decision)
First Posted : January 7, 2021
Last Update Posted : February 9, 2022
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:
This is a first exploration of GLPG3970 in subjects with active primary Sjogren's Syndrome to evaluate the efficacy, safety and tolerability and determine its pharmacokinetics (PK) profile compared to placebo.

Condition or disease Intervention/treatment Phase
Primary Sjögren Syndrome Drug: GLPG3970 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome
Actual Study Start Date : January 28, 2021
Actual Primary Completion Date : October 28, 2021
Actual Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GLPG3970
Participants will receive GLPG3970 tablet, orally, once daily for 12 weeks.
Drug: GLPG3970
GLPG3970 film-coated tablet.

Placebo Comparator: Placebo
Participants will receive placebo tablet, orally, once daily for 12 weeks.
Drug: Placebo
Placebo film-coated tablet.

Primary Outcome Measures :
  1. Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 12 [ Time Frame: Baseline and Week 12 ]
  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity [ Time Frame: From first dose up to Follow-up (Week 16) ]

Secondary Outcome Measures :
  1. Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 4, 8, and 12 [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
  2. Change from baseline in EULAR ESSDAI Score Over Time at Weeks 4, 8, and 12 [ Time Frame: Baseline, Weeks 4, 8, and 12 ]
  3. Observed Plasma Trough Concentration (Ctrough) of GLPG3970 [ Time Frame: Predose (within 30 minutes prior to dosing) on Days 8, 29, 57, and 85 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Documented diagnosis of primary Sjögren's Syndrome (pSS) for <10 years prior to screening AND defined by the classification criteria >=4 described by the American College of Rheumatology - European League Against Rheumatism (ACR-EULAR).
  2. Participant has an ESSDAI score >=5 assessed on 7 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematological, and biological.
  3. Participant has an ESSPRI score >=5.
  4. Participant has stimulated whole salivary flow rate of >=0.1 mL/min.
  5. Participant has positive serum titers of anti-Sjögren's-syndrome-related antigen A (anti-SS-A)/Ro and/or anti-SS-B/La antibodies.
  6. Participants already on treatment should be on stable standard of care (SoC) for at least 4 weeks prior to first investigational product (IP) dosing.

    The following SoC medications are permitted:

    • Corticosteroids <=7.5 mg/day (prednisone or equivalent); AND/OR
    • Non-steroidal anti-inflammatory drugs (NSAIDs); AND/OR
    • One single antimalarial at a stable dose (hydroxychloroquine <=400 mg/day; quinacrine 100 mg/kg/day, or chloroquine <=250 mg/day); AND/OR
    • One single immunosuppressant at a stable dose (methotrexate [MTX] <=10 mg/week or azathioprine [AZA] <=2 mg/kg/day); AND/OR
    • One single cholinergic stimulant at a stable dose (e.g., pilocarpine, cevimeline).
  7. Female participant of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin or urine dipstick) pregnancy test.
  8. Female participant of childbearing potential or male participant must agree to use highly effective contraception/preventive exposure measures.

Key Exclusion Criteria:

  1. Secondary Sjögren's syndrome according to the ACR-EULAR (2016) classification.
  2. History or presence of unstable condition not related to Sjögren's Syndrome that, in the opinion of the investigator, could constitute an unacceptable risk when taking the IP or interfere with the interpretation of data.
  3. Participant has any active systemic infection within 2 weeks prior to first IP dosing, or poorly controlled chronic cardiac, pulmonary, or renal disease.
  4. Participant has a known or suspected history of or a current immunosuppressive condition, or a history of opportunistic infections (e.g., human immunodeficiency virus [HIV] infection, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis).
  5. Participant has a chronic hepatitis B virus (HBV) infection, as defined by persistent HBV surface antigen (HBsAg) positivity. Participant has hepatitis C virus (HCV) infection, as defined by positive HCV antibody at screening and detectable HCV viremia. Participants with positive HCV antibody must undergo reflex HCV ribonucleic acid (RNA) testing, and participants with HCV RNA positivity will be excluded. Participants with positive HCV antibody and negative HCV RNA are eligible.
  6. Participant testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected at screening based on real time polymerase chain reaction (RT-PCR) or at baseline based on immunoglobulin M (IgM) immunoassay, or participants who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Participants presenting any signs or symptoms of SARS-CoV-2 infection, as detected prior to first IP dosing following careful physical examination (e.g., cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc). In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection.
  7. Participant has taken any disallowed therapies:

    • Mycophenolate mofetil (MMF) within a week prior to screening.
    • Cyclosporine/Tacrolimus within a week prior to screening.
    • Cyclophosphamide within 6 months prior to screening.
    • Ocular medicines (e.g., topical cyclosporine, topical NSAIDs/ corticosteroids) for at least 4 weeks prior to screening, except for a sporadic use.
    • Biologics such as, but not limited to, rituximab, abatacept, and any other unapproved biologic within 6 months prior to screening.
    • Plasmapheresis within 12 weeks prior to screening.
    • Plasma exchange within 12 weeks prior to screening.
    • Intravenous immunoglobulin (IVIG) therapy within 24 weeks prior to screening.
    • Other prohibited medications within 2 weeks or 5 half-lives, whichever is longer, prior to first IP dosing.
  8. Concurrent use of anticholinergic agents or any other medication known to cause dry mouth/dry eyes that, in the opinion of the investigator, are a contributing factor to the participant's dryness and/or use of anticholinergic agents not contributing to this dryness, if not stable at least 4 weeks prior to screening.
  9. Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis.
  10. Participant has a history of lymphoma or any malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of cervix which is considered cured with minimal risk of recurrence.
  11. Participant has severe organ manifestation or life-threatening condition, or has planned a surgery during the study.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700280

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Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, France, 33000
CHU Nice Hôpital L'Archet
Nice, France, 06202
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Charite - Universitatsmedizin Berlin
Berlin, Germany, 10117
Universitaetsklinikum Freiburg
Freiburg, Germany, 79106
General Hospital of Athens Laiko
Athens, Greece, 11527
Obudai Egeszsegugyi Centrum Kft
Budapest, Hungary, 1036
Debreceni Egyetem
Debrecen, Hungary, 4032
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, Poland, 85-168
Centrum Medyczne Plejady
Krakow, Poland, 30-363
ETG Lublin
Lublin, Poland, 20-412
Centrum Badan Klinicznych S.C.
Poznań, Poland, 60-773
Medycyna Kliniczna
Warsaw, Poland, 00-874
NZOZ Centrum Medyczne Reuma Park
Warsaw, Poland, 02-691
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 8035
Medical Center Harmoniya Krasy
Kyiv, Ukraine, 1135
Sponsors and Collaborators
Galapagos NV
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Study Director: Catherine Vincent Galapagos NV
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT04700280    
Other Study ID Numbers: GLPG3970-CL-207
2020-003298-22 ( EudraCT Number )
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galapagos NV:
Primary Sjögren Syndrome
Sjögren Syndrome
Autoimmune Diseases
Rheumatic Diseases
Sicca Syndrome
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases