A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

Bio-Thera Solutions1 个研究点分布在 1 个国家目标入组 556 人2021年7月6日

适应症Plaque Psoriasis

干预措施BAT2206 Stelara (EU-sourced)

相关药物BAT2206 Stelara (EU-sourced)

概览

阶段: 3 期
干预措施: BAT2206
疾病 / 适应症: Plaque Psoriasis
发起方: Bio-Thera Solutions
入组人数: 556
试验地点: 1
主要终点: PASI
状态: 已完成
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis.

The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.

注册库

clinicaltrials.gov

开始日期

2021年7月6日

结束日期

2023年7月7日

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bio-Thera Solutions

责任方

Sponsor

入排标准

入选标准

•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:
•sPGA ≥ 3, and
•body surface area affected by chronic plaque-type psoriasis ≥ 10%
•Failed to respond to, or have a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate or psoralen and ultraviolet (UV) A
•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 15 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 15 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.

排除标准

•Have any forms of psoriasis at the time of the screening visit other than plaque-type such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
•Have previously received ustekinumab, a biosimilar of ustekinumab, or any drug that targets interleukin-12 or interleukin-
•Have received any biologic agents other than those prohibited (see exclusion #2) within 12 weeks or 5 half-lives (whichever is longer) before the baseline visit.
•Have received topical therapies for the treatment of psoriasis (such as corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline visit.
•Have received UVA phototherapy (with or without oral psoralen), UVB phototherapy, any systemic steroids or nonbiological drugs for the treatment of psoriasis within 4 weeks before baseline visit
•Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before baseline visit
•Have received any herbal remedies or traditional medicines used to treat psoriasis within 4 weeks before baseline visit
•History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex.
•History of invasive infection (eg, histoplasmosis, coccidioidomycosis, blastomycosis).
•Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization ≤ 8 weeks before baseline visit or oral antibiotics ≤ 2 weeks before baseline visit. Minor fungal infections may be allowed.

研究组 & 干预措施

BAT2206

Patients who weigh ≤ 100 kg: BAT2206 45 mg (1 injection of 45 mg/0.5 mL) by SC injection via PFS. Patients who weigh \> 100 kg: EU-sourced Stelara 90 mg (2 injections of 45 mg/0.5 mL each) by SC injection via PFS.

干预措施: BAT2206

Stelara (EU-sourced)

Patients who weigh ≤ 100 kg: EU-sourced Stelara 45 mg (1 injection of 45 mg/0.5 mL) by SC injection via PFS. Patients who weigh \> 100 kg: EU-sourced Stelara 90 mg (2 injections of 45 mg/0.5 mL each) by SC injection via PFS.

干预措施: Stelara (EU-sourced)

结局指标

主要结局

PASI

时间窗: 0-12 weeks

Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12

次要结局

PASI score(Weeks 4, 8, 16, 20, 28, 40, and 52)
PASI-50/75/90/100(Weeks 4, 8, 12, 16, 20, 28, 40, and 52)
Static Physician's Global Assessment (sPGA) score(Weeks 4, 8, 12, 16, 20, 28, 40, and 52)