EUCTR2016-002995-29-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
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
- 1,040
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. Be a man or a woman at least 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 =12 at screening and at baseline.
- •4. Have an IGA =3 at screening and at baseline.
- •5. Have an involved BSA =10% at screening and at baseline.
- •6. Be a candidate for phototherapy or systemic treatment for psoriasis
- •7. Be considered, in the opinion of the investigator, suitable candidates for secukinumab (Cosentyx) therapy according to their country's approved secukinumab product labeling.
- •Reproduction-related inclusion criteria:
- •8. Before the first administration of study drug, a woman must be either:
- •- Not of childbearing potential: premenarchal; postmenopausal; permanently sterilized or otherwise
- •be incapable of pregnancy.
- •- Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies
- •9. A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections.
- •10. A woman must agree not to donate eggs for the purposes of assisted reproduction during the study and for at least 16 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab.
- •11. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control or a partner with an occlusive cap during the study and for at least 16 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab. All men must also agree to not donate sperm during the study and for at least 16 weeks after receiving the last administration of secukinumab or at least 12 weeks after receiving the last administration of guselkumab.
- •Infectious disease-related inclusion criteria:
- •12. Are considered eligible according to the following TB screening criteria:
- •- Have no history of latent or active TB before screening.
- •o 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.
- •o It is the responsibility of the investigator to verify the adequacy of previous anti-TB 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 the first administration of study drug.
- •- Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active
- •TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study drug. Within 2 months before the first administration of study
排除标准
- •1. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- •2. Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months.
- •3. Has unstable suicidal ideation or suicidal behavior, that may be defined as an eC-SSRS rating at screening of: Suicidal ideation with intention to act (4”), Suicidal ideation with specific plan and intent (5”), or a suicide attempt in the last 6 months and is confirmed to be at risk by the investigator based on an evaluation by a mental health professional. The final decision on excluding a subject will be made at the judgment of the investigator.
- •4. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drug).
- •5. 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.
- •6. Is pregnant, nursing, or planning a pregnancy while enrolled in this study and within 12 weeks following the last administration of study drug.
- •7. Has a nonplaque form of psoriasis
- •8. Has current drug-induced psoriasis
- •9. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the subject is expected to participate in the study.
- •10. Is known to have had a substance abuse (drug or alcohol) problem within the previous 12 months.
- •11. Had a known allergy or sensitivity to products containing latex.
- •Please refer to protocol pages 27-30 for all the exclusion criteria
研究者
相似试验
进行中（未招募）
1 期
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis (ReSTORE)Candidemiainvasive candidiasis.MedDRA version: 20.0Level: LLTClassification code 10064954Term: Invasive candidiasisSystem Organ Class: 100000004862MedDRA version: 20.0Level: LLTClassification code 10060573Term: CandidemiaSystem Organ Class: 100000004862EUCTR2018-002630-21-DECidara Therapeutics Inc.218
进行中（未招募）
不适用
A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety and Efficacy of ABT-874 to Methotrexate in Subjects with Moderate to Severe Chronic Plaque Psoriasis.EUCTR2007-004687-47-FIAbbott GmbH & Co. K.G.371
已完成
3 期
A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Placebo Plus Best Supportive Care in Subjects with Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia due to IPSS Lower-risk Myelodysplastic Syndromes.Myelodysplastic Syndromespreleukemia10018865NL-OMON47302Celgene Corporation12
招募中
3 期
A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phaseschronic inflammation of the colon10017969Ulcerative ColitisNL-OMON44753Shire Development LLC16
进行中（未招募）
不适用
A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety and Efficacy of ABT-874 to Methotrexate in Subjects with Moderate to Severe Chronic Plaque PsoriasisModerate to severe chronic plaque psoriasisMedDRA version: 9.1Level: LLTClassification code 10037153Term: PsoriasisEUCTR2007-004687-47-GBAbbott GmbH & Co. K.G.317