A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.

Inclusion Criteria:

• Patients must provide written, signed, informed consent.

• Patients must have a diagnosis of Rheumatoid Arthritis (RA) according to AmericanCollege of Rheumatology (ACR) criteria or the 2010 ACR/European League AgainstRheumatism classification, for at least 6 months prior to first administration ofstudy drug.

• Patients must have active RA at screening and baseline (Day 1 of the study).

• Patients who have active disease despite csDMARD (conventional syntheticdisease-modifying antirheumatic drugs) therapy for at least 3 months prior to Day 1of the study.

• Patients must have had an inadequate response to previous anti-TNF⍺ (anti-tumornecrosis factor alpha) biological agent(s) for the treatment of RA and meet thewashout period prior to Day 1 of the study.

Exclusion Criteria:

• Patients receiving oral agents, except for medications listed in inclusion criteriafor the treatment of RA.

• Patients who have previously received any other or biological agent for thetreatment of RA, other than anti-TNF⍺ inhibitor(s).

• Patients who have a current or past history of hepatitis B virus (HBV) infection;positive test for hepatitis C virus (HCV) antibody; positive test for humanimmunodeficiency virus (HIV); history of or concurrent interstitial pneumonia; acuteinfection requiring oral antibiotics within 2 weeks, or parenteral injection ofantibiotics within 4 weeks prior to first administration of the study drug; otherserious infection within 6 months prior to first administration of study drug;recurrent herpes zoster or other chronic or recurrent infection within 6 weeks priorto first administration of the study drug; past or current granulomatous infectionsor other severe or chronic infection; positive test for tuberculosis (TB) or otherevidence of TB.

• Patients with uncontrolled diabetes mellitus, or uncontrolled hypertension (systolicblood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg).

• Patients with any other inflammatory or rheumatic diseases that could impact theevaluation of the effect of the study drug.

• Patients with a history of malignancy within 5 years prior to first administrationof the study drug, except completely excised and cured squamous cell carcinoma,carcinoma of the cervix in situ, cutaneous basal cell carcinoma, or cutaneoussquamous cell carcinoma.

• New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolledcardiac disease or heart attack within 6 months prior to first administration of thestudy drug.

• Female patients who are currently pregnant, breastfeeding or planning to becomepregnant or breastfeed within 6 months of the last dose of the study drug.

Other protocol-defined inclusion/exclusion criteria could apply.