EUCTR2013-001370-20-GR进行中（未招募）1 期
OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- 性别
- All
入选标准
- •To be eligible for enrollment in the study, subjects must meet all of the following criteria:
- •All Subjects
- •1. Adults (18 through 70 years of age) with clinically-documented diagnosis of PV for >2 months and <10 years.
- •2. History of biopsy consistent with PV (H and E staining and direct
- •immunofluorescence). If no history, a biopsy may be performed during the Screening Period.
- •3. At least 1 previous episode of a failed steroid taper (ie, disease flare/relapse at a prednisone/prednisolone dose >10 mg/day).
- •Additional Criteria Prior to Randomization
- •4. Screening anti-Dsg antibodies consistent with a diagnosis of PV (ie, elevated anti-Dsg3 antibodies).
- •5. Has initiated and received a stable dose of prednisone/prednisolone from a minimum of 20 mg/day (eg, 0.25 mg/kg/day for an 80-kg person) up to a maximum of 120 mg/day or 1.5 mg/kg/day (whichever is higher) for >= 2 weeks prior to
- •randomization. (Note: subjects who are on every-other-day dosing regimens need to change to a daily dosing regimen for >= 2 weeks during the Screening Period in order to qualify.)
- •6. Has exhibited PV disease control, defined as no new lesions for >= 2 weeks.
- •Additional Criteria for Female Subjects
- •7. A female subject is eligible to enter the study if she:
- •a. Is of nonchildbearing potential, who is documented as either surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or post-hysterectomy) or is postmenopausal without menses for >2 years. Women who are <2 years postmenopausal are required to have menopausal status confirmed by folliclestimulating hormone (FSH) and estradiol levels at the screening evaluation. If FSH and estradiol levels do not provide confirmation of menopause, subject will be considered to be of childbearing potential.
- •b. Is of childbearing potential, defined as a woman who has functional ovaries, ducts, and a uterus with no documented impairment that would cause sterility. This includes women with oligomenorrhea (even severe), women who are perimenopausal, and women who have just begun to menstruate. Subject must:
- •- Have a negative serum pregnancy test at screening
- •- Agree to the consistent and correct use of acceptable methods of contraception during heterosexual intercourse, beginning when the subject provides informed consent and lasting until 6 months after last dose of investigational product. Acceptable methods of contraception are limited to the following:
- •-Oral contraceptives (either combined or progesterone only)
- •-Injectable progesterone
- •-Levonorgestrel implants
- •-Estrogenic vaginal ring
- •-Percutaneous contraceptive patches
- •-Intrauterine device or intrauterine system with a documented failure rate of <1% per year
- •-Male partner sterilization (vasectomy with documentation of
- •azoospermia) prior to the female subject’s entry into the study; this male must be the subject’s sole partner
- •-Double-barrier method: condom and an occlusive cap (diaphragm or
- •cervical/vault caps) with a vaginal spermicidal agent
- •(foam/gel/film/cream/suppository)
- •-Complete abstinence from heterosexual intercourse
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated with, or beneficary of, a social security category.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 121
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Subjects meeting any of the following criteria will not be enrolled:
- •1. Diagnosis of pemphigus foliaceus, paraneoplastic pemphigus, or other autoimmune blistering disease (other than pemphigus vulgaris).
- •2. Past or current history of hypersensitivity to components of the investigational product or medically significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
- •3. Prior treatment with rituximab without achieving disease control within 6 months of initiating rituximab dosing.
- •4. Prior treatment with any of the following within the specified periods (refer toprotocol, table page 32)
- •5. Confirmed PML, or neurological findings potentially consistent with PML.
- •6. Evidence or history of clinically significant infection including:
- •-Chronic or ongoing active infectious disease requiring long-term systemic treatment, including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, or active hepatitis C.
- •-Positive test for HBsAg. For HBsAg negative, but anti-HBc positive (regardless of HBsAb status), an HBV DNA test will be performed and the subject will be excluded if results are positive. Consult with a physician experienced in the care and management of subjects with hepatitis B to manage/treat subjects who are
- •anti-HBc positive.
- •-History of positive serology for human immunodeficiency virus.
- •-Previous serious opportunistic or atypical infections.
- •-Prior history, or suspicion, of tuberculosis.
- •7. Past or current malignancy, except for:
- •-Cervical carcinoma Stage 1B or less.
- •-Noninvasive basal cell and squamous cell skin carcinoma.
- •-Cancer diagnoses with a duration of complete response (remission) >5 years.
- •Note: A history of hematologic malignancy excludes a subject from
- •participation, regardless of response.
- •8. Significant concurrent, uncontrolled medical condition that could affect the subject’s safety, impair the subject’s reliable participation in the study, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol.
- •9. Any of the following screening laboratory values:
- •-White blood cells (WBC) <3.8 GI/L (<3800/mm3).
- •-Neutrophils <2 GI/L (<2000/mm3).
- •-Platelets <130 GI/L (<130,000/mm3).
- •-Circulating IgG, IgA, or IgM levels <10% of the LLN and requiring treatment in the opinion of the investigator.
- •-Alanine aminotransferase (ALT) >2.0 times the upper limit of normal (ULN).
- •-Aspartate aminotransferase (AST) >2.0 x ULN.
- •-Alkaline phosphatase (ALP) >1.5 x ULN.
- •-Bilirubin >1.5 x ULN (except in cases of isolated predominantly indirect hyperbilirubinemia due to Gilbert’s syndrome).
- •10. Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives, or the duration of biological effect (whichever is longer) prior to Screening.
- •11. Electrocardiogram (ECG) showing a clinically significant abnormality or showing a QTc interval =450 msec (=480 msec for subjects with a bundle branch block) (ECG to be obtained during Screening/prior to receiving the first dose of study drug).
- •12. Woman who is breastfeeding.
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