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Clinical Trials/PER-054-11
PER-054-11
Unknown
未知

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

OVARTIS BIOSCIENSES PERU S.A.,0 sites0 target enrollmentJanuary 2, 2012
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
OVARTIS BIOSCIENSES PERU S.A.,
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 2, 2012
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
OVARTIS BIOSCIENSES PERU S.A.,

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Outcomes

Primary Outcomes

Not specified

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