EUCTR2020-002915-23-GR进行中（未招募）1 期
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS) - ADDRESS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- argenx BV
- 入组人数
- 213
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
- •1. Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits).
- •2. The participant is male or female, and aged from 18 years at the time of signing the informed consent form (ICF).
- •3. The participant has a clinical diagnosis of PV (mucosal, cutaneous, mucocutaneous) or PF that has been confirmed by cutaneous histology,
- •positive direct immunofluorescence (IF), and positive indirect IF and/or ELISA.
- •4. The participant meets 1 of the following profiles:
- •a. Newly diagnosed disease with PDAI =15 at baseline and naïve to
- •b. Newly diagnosed disease with PDAI =15 while receiving a first course of oral prednisone (or equivalent). According to clinical
- •judgment, the participant has shown no significant improvement of PV or PF signs for at least 2 weeks before baseline and is considered fit to
- •start prednisone treatment at 0.5 mg/kg qd at baseline.
- •c. Experiencing flare with PDAI =15, a maximum of 4 years since disease onset, and off prednisone therapy ± a conventional
- •immunosuppressant (eg, azathioprine, cyclophosphamide, methotrexate,mycophenolate mofetil) or dapsone. Note: conventional
- •immunosuppressants and dapsone must be discontinued before baseline.
- •d. Experiencing flare with PDAI =15, a maximum of 4 years since disease onset, and receiving a tapered dose of oral prednisone (or
- •equivalent), provided that prednisone has been given at stable dose ± a conventional immunosuppressant (eg, azathioprine, cyclophosphamide,
- •methotrexate, mycophenolate mofetil) or dapsone for at least 2 weeks and participants are fit to start prednisone treatment at 0.5 mg/kg qd at
- •baseline. Note: conventional immunosuppressants and dapsone must be discontinued before baseline.
- •5. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those
- •participating clinical trials and:
- •a. Male participants:
- •-Male participants must agree to use acceptable method of contraception, from signing the ICF until the last dose of IMP.
- •b. Female participants:
- •- Women of childbearing potential must:
- •--have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before the IMP can be
- •administered.
- •-- agree to use a highly effective or acceptable contraception method, which should be maintained at minimum until the last dose of IMP.
- •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 149
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •.1. Participant has a confirmed diagnosis of paraneoplastic pemphigus, drug-induced pemphigus, pemphigus vegetans, pemphigus
- •erythematosus, or any other non-PV/non-PF autoimmune blistering disease.
- •2. Participants with mild disease severity as defined by PDAI <15 at baseline.
- •3. Participants who show a significant improvement of PV or PF in the period from screening to baseline according to clinical judgment (eg, the
- •Participant has achieved DC or a substantial reduction in PDAI activity score during screening period).
- •4. The Participant has been administered therapy other than oral prednisone, conventional immunosuppressants (eg, azathioprine,
- •cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone within 2 months before the baseline visit and that can affect clinical
- •disease activity. For example, excluded medications are intravenous methylprednisolone, dapsone, sulfasalazine, tetracyclines, nicotinamide
- •at doses above the recommended daily allowance (RDA)/dietaryreference intake (DRI), plasmapheresis/ plasma exchange,
- •immunoadsorption, and IVIg. Note: conventional immunosuppressants and dapsone must be discontinued before baseline. Nicotinamide doses
- •at or below RDA/DRI from oral supplements is allowed.
- •5. Use of any monoclonal antibody (including rituximab or another antiCD20 biologic) within 6 months before the baseline visit.
- •6. Known hypersensitivity to any of the components of the administered treatments.
- •7. The participant has a known contraindication to oral prednisone.
- •8. The participant has a history of refractory disease, as defined by a failure to respond to first-line and second-line therapies.
- •9. Participants who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for =3 years
- •before first IMP administration. Participants with any of the following cancers can be included at any time, provided they are adequately
- •treated prior to their participation in the study:
- •a. Basal cell or squamous cell skin cancer
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histological finding of prostate cancer (TNM stage T1a or
- •10. Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major
- •surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or
- •put the participant at undue risk.
- •11. Pregnant and lactating women and those intending to become pregnant during the trial.
- •12. Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
- •13. Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical
- •symptoms of PV or PF or put the participant at undue risk.
- •14. The participant has a Karnofsky performance score <60%.
- •15. Vaccination with live/attenuated viral vaccines within 28 days prior to randomization.
- •16. The participant has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
- •17. Positive serum test at screening for an active viral infection with any of the following conditions:
- •a. Hepatitis B Virus (HBV)
- •b. Hepatitis C Virus (HCV)
- •c. HIV based on test results that are associated with an AIDS- defining condition or a CD4 count < =200 cells/mm3
- •18. The participant has total immunoglobulin G (IgG) <6 g/L at screening.
研究者
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