NL-OMON55954已完成3 期
A phase 3, randomized, double-blind, multicenter, placebo-controlled study of Inebilizumab efficacy and safety in IgG4-related disease - MITIGATE
Viela Bio, Inc. / Horizon Therapeutics Ireland DAC0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female adults, who have reached the age of consent in the applicable
- •region (eg, >= 18 years in the US).
- •2. Written informed consent and any locally required authorization (eg, data
- •Privacy) obtained from the subject prior to performing any protocol-related
- •procedures, including screening evaluations.
- •3. Clinical diagnosis of IgG4-RD.
- •4. Fulfillment of the 2019 ACR/EULAR classification criteria (Appendix A) as
- •determined by the Eligibility Committee. Specifically, subjects must meet the
- •classification criteria entry requirements (including involvement of one of the
- •following organs: pancreas, bile ducts/biliary tree, orbits, lungs, kidneys,
- •lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges,
- •or thyroid gland [Riedel*s thyroiditis]), must not meet any of the
- •classification criteria exclusions, and must achieve at least 20 classification
- •criteria inclusion points.
- •5. Experiencing (or recently experienced) an IgG4-RD flare that requires
- •initiation or continuation of GC treatment at the time of informed consent.
- •This criterion may be met in two ways:
- •* On GC therapy for recent IgG4-RD flare, having received a maximum of 4 weeks
- •of treatment prior to informed consent at a dose no higher than 60 mg/day
- •prednisone or equivalent, and at 20 mg/day prednisone or equivalent on the day
- •prior to randomization, or
- •* Experiencing active disease not currently being treated at the time of
- •informed consent, with planned initiation of treatment for flare with GC at a
- •maximum dose of 60 mg/day prednisone (or equivalent) and with a plan to be
- •treated at a dose of 20 mg/day of prednisone (or equivalent) on the day prior
- •to randomization, for a total duration of GC treatment during screening period
- •of at least 3 weeks at the time of randomization.
- •This GC therapy can either be newly initiated or be increased from a
- •maintenance dose of <= 10 mg/day of prednisone or equivalent. Subjects unable to
- •be tapered to 20 mg/day of prednisone or equivalent by Visit 2 may not be
- •randomized.
- •Total duration of GC treatment must be at least 3 weeks and not exceed 8 weeks
- •prior to randomization.
- •6. IgG4-RD affecting at least 2 organs/sites at any time in the course of
- •IgG4-RD with documentation to confirm. One organ must meet the requirements for
- •the ACR/EULAR classification criteria (inclusion 4); the second organ is as
- •defined by the investigator.
- •7. Willing and able to comply with the protocol, complete study assessments,
- •and complete the study period.
- •8. Non-sterilized male subjects who are sexually active with a female partner
- •of childbearing potential must use a condom with spermicide (where spermicide
- •is available) from Day 1 through to the end of the study and must agree to
- •continue using such precautions for at least 6 months after the final dose of
- •Females of childbearing potential who are sexually active with a non-sterilized
- •male partner must use a highly effective method of contraception (Table 2 on
- •page 36 of Protocol Amendment 3 dated 16 April 2020) from signing informed
- •consent and must agree to continue using such precautions through the end of
- •the follow-up of the study and at least 180 days after the last dose of IP;
- •cessation of contraception after this point should be discusse
排除标准
- •1. Severe cardiovascular, respiratory, endocrine, gastrointestinal,
- •hematological, neurological, psychiatric, or systemic disorder, or any other
- •condition that, in the opinion of the Investigator, would place the patient at
- •unacceptable risk of complications, interfere with evaluation of the IP, or
- •confound the interpretation of patient safety or study results. 2. History of
- •solid organ or cell-based transplantation. 3. Known immunodeficiency disorder.
- •4. Active malignancy or history of malignancy that was active within the last
- •10 years, except as follows: * In situ carcinoma of the cervix following
- •apparently curative therapy > 12 months prior to screening, * Cutaneous basal
- •cell or squamous cell carcinoma following apparently curative therapy, or *
- •Prostate cancer treated with radical prostatectomy or radiation therapy with
- •curative intent > 3 years prior to screening and without known recurrence or
- •current treatment. or * Thyroid cancer for which surgery has been performed and
- •there is no evidence of active disease. 5. Receipt of any biologic B
- •cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab,
- •inebilizumab) in the 6 months prior to screening. 6. Receipt of non-depleting
- •B-cell-directed therapy (eg, belimumab), abatacept, or other biologic
- •immunomodulatory agent within 6 months prior screening. 7. Receipt of
- •non-biologic DMARD or immunosuppressive agent other than GCs (eg, azathioprine,
- •mycophenolate mofetil, methotrexate, others) within 4 weeks prior to screening.
- •8. Receipt of any investigational agent < 12 weeks or < 5 half-lives of the
- •drug (whichever is longer) prior to screening. 9. Inability to be tapered off
- •of GC therapy by 8 weeks post-randomization (other than <= 2.5 mg/day prednisone
- •or equivalent for treatment of adrenal insufficiency or intolerance of taper)
- •in the opinion of the Investigator. 10. Receipt of live vaccine or live
- •therapeutic infectious agent within the 2 weeks prior to screening. 11.
- •Pregnancy, lactation, or planning to become pregnant within 6 months of the
- •last dose of IP. 12. Positive test for, or prior treatment for, hepatitis B or
- •HIV infection. A positive test for hepatitis B is detection of either (1)
- •hepatitis B surface antigen (HBsAg); or (2) hepatitis B core antibody
- •(anti-HBc); and in Japan only (3) hepatitis B surface antibody (HBsAb). 13.
- •History of untreated hepatitis C infection, or positive antibody test for
- •hepatitis C virus (HCV) unless patient is considered to be cured following
- •antiviral therapy and has a HCV viral load below the limit of detection at
- •least 24 weeks after completion of treatment at site or central lab. 14.
- •Evidence of active tuberculosis (TB) or being at high risk for TB based on: *
- •History of active TB or untreated/incompletely treated latent TB. Patients with
- •a history of active or latent TB who have documentation of completion of
- •treatment according to local guidelines may be enrolled. * History of recent (<=
- •12 weeks of screening) close contact with someone with active TB (close contact
- •is defined as >= 4 hours/week OR living in the same household OR in a house
- •where a person with active TB is a frequent visitor). * Signs or symptoms that
- •could represent active TB by medical history or physical examination. *
- •Positive, indeterminate, or invalid interferon-gamma rel
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