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

• ClinicalTrials.gov Identifier: NCT04700280
• Recruitment Status: Terminated
• First Posted: January 7, 2021
• Last Update Posted: February 9, 2022
• Sponsor: Galapagos NV
• Information provided by (Responsible Party): Galapagos NV

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

France

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Bordeaux, France, 33000

CHU Nice Hôpital L'Archet

Nice, France, 06202

CHU Strasbourg - Nouvel Hôpital Civil

Strasbourg, France, 67091

Germany

Charite - Universitatsmedizin Berlin

Berlin, Germany, 10117

Universitaetsklinikum Freiburg

Freiburg, Germany, 79106

Greece

General Hospital of Athens Laiko

Athens, Greece, 11527

Hungary

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary, 1036

Debreceni Egyetem

Debrecen, Hungary, 4032

Poland

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

Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 8035

Ukraine

Medical Center Harmoniya Krasy

Kyiv, Ukraine, 1135

Sponsors and Collaborators

Galapagos NV

Investigators

• Study Director: Catherine Vincent; Galapagos NV

More Information

• 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
• Last Update Posted: February 9, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Sjogren's Syndrome; Syndrome; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases