Surgery in patients with psoriasis, Specialities

surgery in patients with psoriasis

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WOCBP must agree to use effective contraception, defined as oral contraceptives with one barrier method, or tubal ligation with one barrier method or double barrier method condom plus spermicide or diaphragm plus spermicide during the study and for at least 6 months after the last dose of investigational product.

Egg donation is not permitted while on study medication and for at least 6 months after the last dose of study medication.

Dublerede henvisninger

Sperm donation is not permitted while on study medication and for at least 6 months after the last dose of study medication. Amíg szedi a surgery in patients with psoriasis készítményt, surgery in patients with psoriasis a vizsgálati készítmény utolsó dózisa után még további 6 hónapig tilos spermiumot adni.

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További kritériumok hogy a beteget be lehessen választani az OLE terápiás szakaszba: Mielőtt megkaphatná a 4 hetente esedékes egy KHK infúziót a vizsgálati készítménnyel az OLE terápiában, a vizsgálati alanyoknak a következő követelményeknek kell megfelelniük: 1 Az alanyok befejezték a kettős vak indukciós terápiát, azaz a hat kettős vak kezelésből legalább ötöt megkaptak, vagy a vizsgálati alany már a kettős vak LTE terápiás szakaszban van, de még nem érte el a Subjects with thyroid disorders, vitiligo, or alopecia are eligible for inclusion.

Subjects with latent TB may be included if prophylactic therapy for latent TB is started at least 4 wk prior to Screening.

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Subjects with potentially untreated other infection are excluded. Subject is allowed vaccinations of inactivated vaccines 21 History of substance abuse within 1 yr of Screening; or active marijuana use or active substance abuse; 22 Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, as determined by the Investigator; 23 Previously participated in a study of KHK Nem aktív vakcinával történő oltás megendett.

Safety - safety and surgery in patients with psoriasis will be determined by physical examination, vital signs, body weight,lead ECGs, and clinical laboratory findings; and the number and percentage of subjects reporting AEs frequency, severity, and relationship to investigational productSAEs, and treatment discontinuation due to AEs. For all subjects who receive KHK at dose levels different than the recommended dose during double-blind Induction Therapy, improvement in the mucosa at Week 12 based on the mean change in the mMES from Baseline Week 0 to Week 12 is the main secondary endpoint.

The other secondary efficacy endpoints at Week 12 for all subjects who receive KHK at other than the recommended dose are the same as those listed and defined above, i.

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