E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Sjogren's Syndrome |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040767 |
E.1.2 | Term | Sjogren's syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <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). − 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 <=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). − Female subject of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin or urine dipstick) pregnancy test. − Female subject of childbearing potential or male subject must agree to use highly effective contraception/preventive exposure measures.
This list only contains the key inclusion criteria. |
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E.4 | Principal 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, 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. − Subject 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, as listed in the clinical study protocol − 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 subject’s dryness and/or use of anticholinergic agents not contributing to this dryness, if not stable at least 4 weeks prior to screening. − 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. - Subject has severe organ manifestation or life-threatening condition, or has planned a surgery during the study.
This list only contains the key exclusion criteria. |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Various timepoints during the trial as per clinical study design. |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Various timepoints during the trial as per clinical study design. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Ukraine |
France |
Germany |
Hungary |
Netherlands |
Poland |
Spain |
United Kingdom |
Greece |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |