CTIS2022-500718-24-00招募中1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBEXELIMAB IN PATIENTS WITH IGG4-RELATED DISEASE (INDIGO) - ZB012-03-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •RCP:1. Males and females, = 18 years of age 2. Clinical diagnosis of IgG4-RD 3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD with a score of = 20 4. Patients must have active IgG4-RD signs/symptoms that require the initiation of GC therapy or the increase in background long-term GC therapy 5. A female patient not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) OR b. A WOCBP who agrees to follow the contraceptive guidance throughout the study and for at least 1 month after the last IMP administration; c.Agree to refrain from egg donation throughout the study and for at least 1 month (i.e.,approximately 5 half-lives) after the last dose of IMP 6. A male patient must: a. Agree to (i) abstain from intercourse or (ii) use contraception throughout the study and for at least 1 month after the last dose of IMP, or (iii) be surgically sterile for the duration of the study AND b. Agree to refrain from donating sperm throughout the study and for at least 1 month after the last dose of IMP 7. A WOCBP must have a negative serum pregnancy test at screening and a negative urine test prior to the first dose of IMP and at all timepoints specified in the protocol 8. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol 9. Willing to comply with all study protocol procedures and complete all study visits 10. Total duration of GC treatment prior to randomization must be = 3 weeks and a maximum of 6 weeks at a dose of 20 to 60 mg/day OLE: 1.Have remained on study and completed the Week 52 RCP visit 2. Have not had IMP discontinued due to the following safety reasons: a. Grade = 3 TEAE that is considered related to obexelimab b.Pregnancy; c. Malignancy; d. Hypersensitivity to IMP; e. Determination that the patient was ineligible for the RCP;f. For any reason deemed necessary by the investigator for patient safety 3. Have not discontinued from IMP due to unblinding of a patient 4. Have not received B-cell-depleting, B-cell-targeted, or other biologic immunomodulatory agents (apart from obexelimab) within the 6 months prior to enrollment in the OLE period. Patients who received B-cell-targeted therapy within 6 to 12 months prior to enrollment in the OLE must have a B-cell count that is within the laboratory reference range, as measured by the central laboratory 5. Have a washout period of at least 4 weeks prior to enrollment into OLE if they have received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs For the rest of the inclusion criteria, please refer to the study protocol.
排除标准
- •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 4 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.
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