A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY OF SUBCUTANEOUS SECUKINUMAB TO DEMONSTRATE EFFICACY AFTER TWELVE WEEKS OF TREATMENT, AND TO ASSESS THE SAFETY, TOLERABILITY AND LONG-TERM EFFICACY UP TO ONE YEAR IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE-TYPE CHRONIC PSORIASIS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2012年1月2日最近更新: 2023年9月4日

研究概览

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•1. SUBJECTS MUST BE ABLE TO UNDERSTAND AND COMMUNICATE WITH THE INVESTIGATOR AND COMPLY WITH THE REQUIREMENTS OF THE STUDY AND MUST GIVE A WRITTEN, SIGNED AND DATED INFORMED CONSENT BEFORE ANY STUDY RELATED ACTIVITY IS PERFORMED. WHERE RELEVANT, A LEGAL REPRESENTATIVE WILL ALSO SIGN THE INFORMED STUDY CONSENT ACCORDING TO LOCAL LAWS AND REGULATIONS.
•2. MEN OR WOMEN AT LEAST 18 YEARS OF AGE AT TIME OF SCREENING.
•3. CHRONIC PLAQUE-TYPE PSORIASIS DIAGNOSED FOR AT LEAST 6 MONTHS BEFORE RANDOMIZATION
•4. MODERATE TO SEVERE PSORIASIS AS DEFINED IN RANDOMIZATION BY:
•PASI SCORE 12 OR GREATER AND
•IGA MOD 2011 SCORE OF 3 OR GREATER (BASED ON A SCALE OF 0-4) AND
•BODY SURFACE AREA (BSA) AFFECTED BY PLAQUE-TYPE PSORIASIS OF 10% OR GREATER.
•5. CANDIDATE FOR SYSTEMIC THERAPY, DEFINED AS HAVING CHRONIC PLAQUE-TYPE PSORIASIS CONSIDERED INADEQUATELY CONTROLLED BY:
•TOPICAL TREATMENT AND/OR
•PHOTOTHERAPY AND/OR
•PREVIOUS SYSTEMIC THERAPY.

•1. FORMS OF PSORIASIS OTHER THAN CHRONIC PLAQUE-TYPE (eg., PUSTULAR, ERYTHRODERMIC AND GUTTATE PSORIASIS)
•2. DRUG-INDUCED PSORIASIS (ie., NEW ONSET OR CURRENT EXACERBATION FROM BETA-BLOCKERS, CALCIUM CHANNEL INHIBITORS OR LITHIUM)
•3. ONGOING USE OF PROHIBITED PSORIASIS TREATMENT (eg., TOPICAL OR SYSTEMIC CORTICOSTEROIDS (CS), UV THERAPY). WASHOUT PERIODS DETAILED IN THE PROTOCOL HAVE TO BE ADHERED TO (TABLE 5-1)
•4. ONGOING USE OF OTHER NON-PSORIASIS PROHIBITED TREATMENTS. WASHOUT PERIODS DETAILED IN THE PROTOCOL HAVE TO BE ADHERED TO (TABLE 5-1). ALL OTHER PRIOR NON-PSORIASIS CONCOMITANT MEDICATIONS MUST BE ON A STABLE DOSE FOR AT LEAST FOUR WEEKS BEFORE RANDOMIZATION
•5. PREVIOUS EXPOSURE TO SECUKINUMAB OR ANY OTHER BIOLOGIC DRUG DIRECTLY TARGETING IL-17 OR THE IL-17 RECEPTOR
•6. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINING AS THE STATE OF A FEMALE AFTER CONCEPTION AND UNTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE hCG LABORATORY TEST (> 5 mIU/mL)
•7. WOMEN OF CHILD-BEARING POTENTIAL, DEFINED AS ALL WOMEN PHYSIOLOGICALLY CAPABLE OF BECOMING PREGNANT, UNWILLING TO USE EFFECTIVE CONTRACEPTION DURING THE STUDY AND FOR 16 WEEKS AFTER STOPPING TREATMENT.

发起方

OVARTIS BIOSCIENSES PERU S.A.,