EUCTR2022-000831-21-DK进行中（未招募）1 期
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF DAXDILIMAB SUBCUTANEOUS INJECTION IN REDUCING DISEASE ACTIVITY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE PRIMARY DISCOID LUPUS ERYTHEMATOSUS - RECAST DLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
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
- 性别
- All
入选标准
- •Eligible participants must meet/provide all of the following criteria:
- •1. Written informed consent and any locally required authorization obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- •3. Adult men or women = 18 and = 75 years of age
- •4. A diagnosis of DLE for = 6 months prior to screening supported by a history of:
- •a. A biopsy or
- •b. a clinical feature score of = 7 on the DLE Classification Criteria (DLECC) scale if a biopsy is not available.
- •5. Currently active discoid lupus with all the following:
- •a. Digital photography adjudicated with central reading to confirm a currently active discoid disease lesion.
- •b. CLASI-A score = 8 related to discoid lesions at Baseline
- •6. Treatment refractory DLE defined as active disease despite current or historical treatment with a systemic treatment including, but not limited to: antimalarial, methotrexate, mycophenolate, azathioprine, dapsone, corticosteroid, thalidomide, or lenalidomide, OR documented history of intolerance to antimalarials and/or immunosuppressive medications.
- •7. Participants with active disease who currently are on any of the following therapies must have been on a stable dosage prior to Screening and must remain on a stable dosage through Randomization and for the entire trial as described below:
- •-Antimalarials must be at a stable dosage for at least 8 weeks prior to Screening and through Randomization.
- •-Methotrexate = 20 mg/week (oral or SC) at stable dosage and route of administration for at least 4 weeks prior to Screening and through Randomization.
- •-Mycophenolate mofetil = 2 g/day or mycophenolic acid = 1.44 g/day at stable dosage for at least 4 weeks prior to Screening and through Randomization.
- •-Azathioprine must be stable for at least 4 weeks prior to Screening and through Randomization.
- •-Corticosteroid equivalent to prednisone = 10 mg/day at stable dosage for at least 4 weeks prior to Screening and through Randomization.
- •-Topical corticosteroids and calcineurin inhibitors at stable dosage for at least 1 week prior to Screening and through Randomization.
- •8. Vaccination status should be up to date per local standards.
- •9. Females are eligible to participate if they are not pregnant or
- •breastfeeding, and one of the following conditions applies:
- •-Is a woman of non-childbearing potential (WONCBP) OR - Is a woman
- •of childbearing potential (WOCBP) and using a contraceptive method
- •that is highly effective (ie, has a failure rate of < 1%) , during the study
- •intervention period and for at least 6 months after the last dose of IP
- •and agrees not to donate eggs (ova, oocytes) for the purpose of
- •reproduction during this period. A WOCBP must:
- •-have a negative serum pregnancy test at Screening and a negative urine
- •pregnancy test at Day 1.
- •-Additional requirements for pregnancy testing during and after study
- •intervention are located in Section 8.3.5 Pregnancy Testing of study
- •-The Investigator is responsible for review of medical history, menstrual
- •history, and recent sexual activity to decrease the risk for inclusion of a
- •woman with an early undetected pregnancy. The Investigator should
- •also evaluate the potential for contraceptive method failure (eg,
- •noncompliance, recently initiated) in relationship to the first dose of IP.
- •10. Males are eligible to particip
排除标准
- •Participants will be ineligible for this trial if they meet any of the following criteria:
- •1. Individuals involved in the conduct of the trial, their employees, or immediate family members
- •2. Participation in another clinical trial with an investigational IP within 4wks prior to Randomization or within 5published half-lives, whichever is longer
- •3. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the IP or interpretation of participant safety or trial results.
- •4. Weight >160kg at Screening
- •5. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous mAb or human Ig therapy
- •6. Breastfeeding/pregnant women/women who intend to become pregnant anytime from signing the ICF through 6months after receiving the last dose of IP
- •7. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other trial assessments
- •8. Major surgery within 8wks prior to Screening or elective surgery planned from Screening through W48
- •9. Splenectomy
- •10. Spontaneous or induced abortion, still or live birth, or pregnancy= 4wks prior to Screening through Randomization
- •11. History of clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6months prior to Randomization; arrhythmia requiring active therapy, except for clinically insignificant extra systoles, or minor conduction abnormalities; or presence of clinically significant abnormality on ECG
- •12. History of cancer within the past 5 years years, except as follows: In situ carcinoma of the cervix treated with apparent success with curative therapy>12months prior to Screening, or Cutaneous basal cell or squamous cell carcinoma treated with curative therapy.
- •13. Any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection
- •14. Participant who has given >499 ml of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) or plans to give blood or plasma during their participation in the trial or up to 6 months after the last IP administration, whichever is longer.
- •15. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis, or plasma exchange within 8wks prior to Randomization and for the total duration of the trial participation.
- •16. Known history of a primary immunodeficiency or an underlying condition, e.g.HIV infection, or a positive result for HIV infection.
- •17. At Screening, any of the following per central laboratory tests:
- •-Aspartate aminotransferase>2.5×upper limit of normal (ULN)
- •-Alanine aminotransferase>2.5×ULN
- •-Total bilirubin>1.5×ULN(unless due to Gilbert’s syndrome)
- •-Neutrophil count<1500/µL (or<1.5×109/L)
- •-Platelet count <135,000/µL (or<135×109/L)
- •-Hemoglobin<10g/dL(or<100g/L)
- •-Total lymphocyte count <800/µL(or<0.8×109/L)
- •-Antinuclear antibody titer>1:320
- •18. All participants will undergo testing for hepatitis B surface antigen
- •(HBsAg) and hepatitis B core antibody (HBcAb) during Screening.
- •19. All participants will undergo testing for hepatitis C antibody (HCVAb)
- •during Screening.
- •20. Active TB, or a positive IFN? release assay (IGRA) test at Screening,
- •unless documented history of appropriate treatment for active or latent
- •21. Any severe herpes virus family infection (including Epstein-Barr
- •virus, cytomegalovirus [CMV])
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