Randomized, Double Blind, Placebo Controlled, Pilot Study To Evaluate The Safety And Efficacy of 2 doses of SPHIRA in subjects with Moderate to Severe Psoriasis

icholas Piramal Research Center0 个研究点目标入组 74 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Subjects of 18- 70 years of age.
•2.Subjects with confirmed diagnosis of plaque psoriasis since at least 6 months.
•3.Subjects with plaque psoriasis having PASI score >10 even after at least one month treatment with topical steroids or for 2 months with other topical agents used in the treatment of psoriasis.
•4.Women of childbearing potential and men agreeing to use adequate contraception
•(hormonal or barrier method of birth control; abstinence) prior to entry into study, during the period of study participation and for at least 4 weeks after withdrawal from the study
•5.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol-specific procedures are performed.

•1.Subject who has received systemic therapy such as Methotrexate or Cyclosporin therapy in the past three months prior to randomization.
•2.Subject who have received TNF alpha inhibitor therapy any time in the past prior to screening.
•3.Subjects with spontaneously improving or rapidly deteriorating plague psoriasis, acute guttate psoriasis, pustular, inverse or erythrodermic psoriasis, Psoriatic arthritis.
•4.Subject with history of cancer including skin cancer.
•5.Subject with serious dermatological infection in past three months requiring systemic therapy.
•6.Any condition for which participation in this study as judged by the Investigator to be detrimental to the patient, such as (but not limited to) history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric diseases
•7.Subject who has uncontrolled hypertension, severe cardiovascular, pulmonary, (specially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease.
•9.Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs
•10.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month, three months prior to screening visit.

发起方

icholas Piramal Research Center