Primary Sjogren's Syndrome MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: GLPG3970
Product Code: G1567970
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not applicable
Current Sponsor code: G1567970
Other descriptive name: GLPG3970
Concentration
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subject between 18-74 years of age (extremes included), on the date of signing the informed consent form (ICF). - Documented diagnosis of pSS for =4 described by the American College of Rheumatology - European League Against Rheumatism (ACR-EULAR). - Subject has an ESSDAI score >=5 assessed on 7 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematological, and biological. - Subject has an ESSPRI score >=5. - Subject has stimulated whole salivary flow rate of >=0.1 mL/min. - Subject has positive serum titers of anti-SS-A/Ro and/or anti-SS-B/La antibodies. - Subjects already on treatment should be on stable standard of care (SoC) for at least 4 weeks prior to first IP dosing. The following SoC medications are permitted: • Corticosteroids =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Secondary Sjögren's syndrome according to the ACR-EULAR (2016) classification. - 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. - Subject has any active systemic infection within 2 weeks prior to first IP dosing, or poorly controlled chronic cardiac, pulmonary, or renal disease. - Subject 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, coccidiodmycosis, pneumocystosis, aspergillosis). - Subject has a chronic hepatitis B virus (HBV) infection, as defined by persistent HBV surface antigen (HBsAg) positivity. Subject has hepatitis C virus (HCV) infection, as defined by positive HCV antibody at screening and detectable HCV viremia. Subjects with positive HCV antibody must undergo reflex HCV ribonucleic acid (RNA) testing, and subjects with HCV RNA positivity will be excluded. Subjects with positive HCV antibody and negative HCV RNA are eligible. - Subject 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 subjects who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection, as detected at screening or baseline 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. - Subject has taken any disallowed therapies before the planned first dose of IP: • 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. - Concurrent use of anticholinergic agents that, in the opinion of the investigator, are a contributing factor to the subject’s dryness. - Subject has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis. - Subject 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. This list only contains the key exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of GLPG3970 compared to placebo on the signs and symptoms of primary Sjögren's Syndrome. - To evaluate the safety and tolerability of GLPG3970 compared to placebo.;Secondary Objective: - To further characterize the efficacy of GLPG3970 compared to placebo on the patient reported signs and symptoms of primary Sjögren's Syndrome. - To characterize the pharmacokinetics (PK) of GLPG3970.;Primary end point(s): - Change from baseline in European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 12. - Number, incidence, and severity of treatment-emergent adverse events (TEAEs).;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as per clinical study design. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score at Week 4, 8, and 12. - Change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score over time at Week 4, 8, and 12. - Observed GLPG3970 plasma trough concentration (Ctrough).;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as per clinical study design. | — |
Countries
France, Germany, Greece, Hungary, Netherlands, Poland, Spain, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Galapagos NV
Outcome results
None listed