EUCTR2016-002135-15-DE进行中（未招募）1 期
Multicenter, randomized, open-label, efficacy assessor-blinded, active comparator-controlled phase 3b study to compare the efficacy of guselkumab to fumaric acid esters (Fumaderm® initial/ Fumaderm®) for adult patients with moderate to severe plaque psoriasis who are candidates for and naive to systemic treatment - POLARIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 114
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
入选标准
- •1. Male or female and =18 years of age
- •2. Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug
- •3. Have a PASI >10 or BSA >10 at screening and at baseline
- •4. Have a DLQI >10 at screening and at baseline
- •5. Be a candidate for systemic treatment for psoriasis
- •6. Topical psoriasis therapy is considered to be inadequate by the investigator due to
- •- inadequate response to, intolerance to or contraindication against topical therapy in the subject’s medical history (documented or reported by the subject)
- •- and/or disease severity at screening and at baseline
- •7. Must be eligible for Fumaderm® treatment according to the SmPC
- •8. Fumaderm® is considered, in the opinion of the investigator, to be an appropriate treatment option
- •9. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
- •10. A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0
- •11. A woman must agree not to donate eggs for the purpose of assisted reproduction during the study and for a period of at least 12 weeks after receiving the last administration of study treatment
- •12. During the study and for a minimum of 1 spermatogenesis cycle after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man
- •who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception during the study and for at least 12 weeks after receiving the last study treatment.
- •who is sexually active with a woman who is pregnant must use a condom, during the study and for at least 12 weeks after receiving the last administration of study treatment.
- •must agree not to donate sperm during the study and for at least 12 weeks after receiving the last administration of study treatment.
- •13. Considered eligible according to the following tuberculosis screening criteria
- •Have no history of latent or active TB before screening. An exception is made for subjects who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first administration of study drug, or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of study drug. It is the responsibility of the investigator to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation.
- •Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination
- •Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before first administration of study drug
- •Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold Plus test result or have a newly identified positive QuantiFERON®-TB Gold
排除标准
- •1. Has received prior systemic treatment of psoriasis including but not limited to
- •- conventional systemic therapy (eg, methotrexate, cyclosporine, fumaric acid esters and acitretine)
- •- apremilast and tofacitinib
- •- drugs targeted for reducing TNF (including but not limited to infliximab, adalimumab or etanercept)
- •- drugs targeted for reducing IL-12, IL-17, or IL-23 (including but not limited to ustekinumab, tildrakizumab [MK3222], secukinumab [AIN457], ixekizumab [LY2439821], or brodalumab [AMG827])
- •- alpha-4 integrin antagonists (including but not limited to natalizumab)
- •2. Has a history or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •3. Has a history of malignancy within 5 years before screening (with the exception of a non-melanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before first study drug administration)
- •4. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- •5. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug)
- •6. Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
- •7. Has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received IV antibiotics for an infection during the 2 months before screening
- •8. Has or has had herpes zoster within the 2 months before screening
- •9. Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
- •10. Has a non-plaque form of psoriasis (eg, erythrodermic, guttate, or pustular)
- •11. Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
- •12. Known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- •13. Contraindications to the use of Fumaderm® initial/ Fumaderm® per local prescribing information
- •14. Has received phototherapy (including, but not limited to, PUVA, narrow-band UVB, balneophototherapy) within 4 weeks of the first administration of study drug
- •15. Has used topical medications/ treatments that could affect psoriasis (including, but not limited to, corticosteroids, anthralin, calcipotriene, topical vitamin D derivatives, retino
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