A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED, MULTICENTER STUDY OF SUBCUTANEOUS SECUKINUMAB TO DEMONSTRATE EFFICACY AFTER TWELVE WEEKS OF TREATMENT, COMPARED PLACEBO AND ETANERCEPT AND TO ASSESS THE SAFETY, TOLERABILITY AND LONG-TERM EFFICACY UP TO ONE YEAR IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE-TYPE PSORIASIS
- Registration Number
- PER-054-11
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 0
1. SUBJECTS MUST BE ABLE TO UNDERSTAND AND COMMUNICATE WITH THE INVESTIGATOR AND COMPLY WITH THE REQUIREMENTS OF THE STUDY (INCLUDING ADMINISTRATION OF S.C. INJECTIONS AT HOME) AND MUST GIVE A WRITTEN, SGNED AND DATED INFORMED CONSENT BEFORE ANY STUDY RELATED ACTIVITY IS ........ WHERE RELEVANT, A LEGAL REPRESENTATIVE WILL ALSO IGN THE INFORMED STUDY ....... 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 AT RANDOMIZATION BY:
• PASI SCORE OF 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 (i.e., NEW ONSET OR CURRENT EXACERBATION FROM BETA-BLOCKERS, CALCIUM CHANNEL INHIBITORS OR LITHIUM).
3. ONGOING USE OF PROHIBITED PSORIASIS TREATMENTS (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 TREATMENTS MUST BE ON STABLE DOSE FOR AT LEAST FOUR WEEKS BEFORE RANDOMIZATION
5. PREVIOUS EXPOSURE TO SECUKINUMAB OR ANY OTHER BIOLOGIC DRUG DIRECTLY TARGETIN IL-17 OR THE IL-17 RECEPTOR
6. PREVIOUS EXPOSURE TO ETANERCEPT
7. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND UNTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE hCG LABORATORY TEST (≥ 5 mlU/mL)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method