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

NCT ID: NCT04700280

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2021-12-27

Brief Summary

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

Conditions

Primary Sjögren Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3970

Participants will receive GLPG3970 400 milligrams (mg) (2 \*200 mg tablet), orally, once daily for 12 weeks.

Group Type: EXPERIMENTAL

GLPG3970

Intervention Type: DRUG

GLPG3970 film-coated tablet.

Placebo

Participants will receive placebo matched to GLPG3970 tablet, orally, once daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo film-coated tablet.

Interventions

GLPG3970

GLPG3970 film-coated tablet.

Intervention Type: DRUG

Placebo

Placebo film-coated tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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).

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 milliliter per minute (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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Vincent

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

General Hospital of Athens Laiko

Athens, , Greece

Debreceni Egyetem

Debrecen, , Hungary

Szpital Uniwersytecki nr 2 im.dr J. Biziela

Bydgoszcz, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

ETG Lublin

Lublin, , Poland

Centrum Badan Klinicznych S.C.

Poznan, , Poland

Medycyna Kliniczna

Warsaw, , Poland

NZOZ Centrum Medyczne Reuma Park

Warsaw, , Poland

Medical Center Harmoniya Krasy

Kyiv, , Ukraine

Countries

Germany; Greece; Hungary; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-003298-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3970-CL-207

Identifier Type: -

Identifier Source: org_study_id