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About
This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2306 with Cosentyx in patients with moderate to severe plaque psoriasis.
The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (Treatment Period 1 [TP1]), and a 28-week secondary treatment period (Treatment Period 2 [TP2]). The study will be a maximum of 56 weeks.
Full description
Primary objective:
• To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis.
Secondary objectives:
Enrollment
Sex
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Inclusion criteria
Male or female ≥ 18 years old with a diagnosis of plaque-type psoriasis for at least 24 weeks before screening.
Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use a highly effective contraceptive precaution throughout the study period and continuing for at least 20 weeks after the last dose of study drug. See APPENDIX 1 for the acceptable highly effective contraceptive methods. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 20 weeks after the last dose of study drug. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits.
Must be willing to provide written consent and to comply with the requirements of the study protocol.
Exclusion criteria
And so on
Primary purpose
Allocation
Interventional model
Masking
502 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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