A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sj gren's Syndrome

  • STATUS
    Recruiting
  • End date
    May 15, 2022
  • participants needed
    30
  • sponsor
    Galapagos NV
Updated on 15 September 2021

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.

Details
Condition Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome, Primary Sjögren Syndrome
Treatment Placebo, GLPG3970
Clinical Study IdentifierNCT04700280
SponsorGalapagos NV
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented diagnosis of primary Sjgren'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)
Participant has an ESSDAI score >=5 assessed on 7 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematological, and biological
Participant has an ESSPRI score >=5
Participant has stimulated whole salivary flow rate of >=0.1 mL/min
Participant has positive serum titers of anti-Sjgren's-syndrome-related antigen A (anti-SS-A)/Ro and/or anti-SS-B/La antibodies
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

Exclusion Criteria

Secondary Sjgren's syndrome according to the ACR-EULAR (2016) classification
History or presence of unstable condition not related to Sjgren'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
Participant has any active systemic infection within 2 weeks prior to first IP dosing, or poorly controlled chronic cardiac, pulmonary, or renal disease
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)
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
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
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
Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis
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
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
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
Participant has severe organ manifestation or life-threatening condition, or has planned a surgery during the study
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