A Phase 3 Study of Obexelimab in Patients with IgG4-Related Disease

You likely can't join if

• RCP: 1. Any exclusion criteria listed in the ACR/EULAR Classification Criteria for IgG4-RD 2. Has disease in only 1 organ system whose primary manifestation is fibrosis (i.e., retroperitoneum fibrosis without aortitis, Riedel’s thyroiditis, fibrosing mediastinitis, sclerosing mesenteritis involvement, etc.) 3. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening 4. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 2 weeks prior to screening 5. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter,prior to screening 6. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening 7. Acute hepatitis B infection (hepatitis B surface antigen-positive), active hepatitis C virus, orHIV infection. Patients will be excluded from the RCP if they have a positive test for active hepatitis B through detection of (a) hepatitis B surface antigen or (b) hepatitis B core antibody. In Japan, patients will be excluded if there is detection of (a) hepatitis B surface antigen (b) hepatitis B surface antibody, or (c) hepatitis B core antibody. 8. Evidence of active tuberculosis (TB) or at high risk for TB as shown by at least one of the following: a. Documented history of active TB or latent TB, unless completion of treatment according to local guidelines; b. Positive, indeterminate, or invalid interferon-gamma release assay results at screening, unless treatment is documented. Patients with an indeterminate test result can repeat the test once either centrally or locally, but if the repeat test is also indeterminate, the patient is excluded; c. Signs of symptoms that could represent active TB; d. Chest radiograph, computed tomography (CT), or magnetic resonance imaging (MRI) that suggests possible diagnosis of TB 9. History or evidence of a clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic, psychiatric, active infection) other than IgG4-RD that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion 10. Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, breast cancer with no recurrence ≥ 5 years following therapy, or prostate cancer with no recurrence ≥ 3 years following prostatectomy) For the rest of the exclusion criteria, please refer to the study protocol.