An Efficacy and Safety Study of Injectable Ravagalimab to Assess Change in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) in Adult Participants With Moderately to Severely Active Primary Sjogren's Syndrome (pSS)

Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

ESSDAI is a systemic disease activity index including 12 domains (i.e., organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, haematological, glandular, constitutional, lymphadenopathic and biological).

Time frame: Up to Week 16

Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

ESSPRI is designed to evaluate the patient symptoms with 3 questions related to the dryness, pain and fatigue a participant has experienced in the prior 2 weeks. It is a numeric rating scale from 0 - 10, with a final score the mean of the 3 questions

Time frame: Up to Week 24

Change From Baseline in Tender Joint Count

An assessment of 68 joints will be done for tenderness by pressure manipulation on physical examination. Joint pain/tenderness will be classified as: present, absent, replaced or no assessment.

Time frame: Up to Week 24

Change From Baseline in Swollen Joint Count

An assessment of 66 joints will be done by directed physical examination. The joints to be examined for swelling are the same as those examined for tenderness, except the hip joints are excluded. Joint swelling will be classified as present, absent, replaced or no assessment.

Time frame: Up to Week 24

Change From Baseline in Salivary Flow (Unstimulated)

Patients will be asked to collect their saliva in a cup every 30 seconds for a total period of 5 minutes. The saliva production is expressed in ml/minute.

Time frame: Up to Week 24

Change From Baseline in Salivary Flow (Stimulated)

Saliva production is stimulated by parafilm and collected in a cup every 30 seconds for a total period of 5 minutes.. The saliva production is expressed in ml/minute.

Time frame: Up to Week 24

Change From Baseline in Lacrimal Flow (Schirmer's Test of Ocular Function)

Lachrymal flow will be assessed by Schirmer's test of ocular function. A small filter paper will be placed in the conjunctival sac for 5 minutes. After that, the degree of wetting is evaluated

Time frame: Up to Week 24

Change From Baseline in Van Bijsterveld Score

The van Bijsterveld score is an ocular score for dryness. The Bijsterveld score is determined by adding up the combined score (from 0 to 3; 0 is normal and 3 is the highest level of staining) in the central and two outer sections of the eye.

Time frame: Up to Week 24

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases. This instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (e.g., sleeping, and social activities). A lower score indicates less negative impact on daily activities.

Time frame: Up to Week 24

Change From Baseline in Patient's Global Assessment of Disease Activity Numeric Rating Scales

Patient's Global Assessment of Disease Activity Numeric Rating Scale allows a patient to score 0 - 10 to assess the patient's overall functionality assessment considering the disease activity within the past week

Time frame: Up to Week 24

Change From Baseline in Physician's Global Assessment of Disease Activity Numeric Rating Scales

Physician's Global Assessment of Disease Activity Numeric Rating Scale allows a physician to score 0 - 10 to assess the patient's overall functionality assessment considering the disease activity within the past week.

Time frame: Up to Week 24

Change from Baseline in anti-Sjogrens-syndrome-related antigen A (anti-SSA)

Change from baseline in anti-SSA s assessed.

Time frame: Up to Week 24

Change from Baseline in anti-Sjogrens-syndrome-related antigen B (anti-SSB)

Change from baseline in anti-SSB is assessed.

Time frame: Up to Week 24

Change from Baseline in antinuclear antibody (ANA)

Change from baseline in antinuclear antibody (ANA) is assessed.

Time frame: Up to Week 24

Change from Baseline in rheumatoid factor (RF)

Change from baseline in rheumatoid factor (RF) is assessed.

Time frame: Up to Week 24

Change from Baseline in high-sensitivity C-reactive protein (hsCRP)

Change from baseline in high-sensitivity C-reactive protein (hsCRP) is assessed.

Time frame: Up to Week 24

Change from Baseline in immunoglobulin M (IgM)

Change from baseline in immunoglobulin M (IgM) is assessed

Time frame: Up to Week 24

Change from Baseline in immunoglobulin M (IgG)

Change from baseline in immunoglobulin M (IgG) is assessed.

Time frame: Up to Week 24

Change from Baseline in immunoglobulin A (IgA)

Change from baseline in immunoglobulin A (IgA) is assessed.

Time frame: Up to Week 24

Change from Baseline in Serum-Free Light Chains

Change from baseline in serum-free light chains is assessed.

Time frame: Up to Week 24

Change from Baseline in Serum C3

Change from baseline in Serum C3 is assessed.

Time frame: Up to Week 24

Change from Baseline in Serum C4

Change from baseline in Serum C4 is assessed.

Time frame: Up to Week 24

Change from Baseline in Haemolytic Complement CH50

Change from baseline in CH50 is assessed.

Time frame: Up to Week 24

Change From Baseline in Focus Score of Sublabial Salivary Gland Biopsy (In Participants With a Screening and Week 24 Biopsy)

Change from baseline in focus score of sublabial salivary gland biopsy is assessed.

Time frame: Week 24