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 site in 1 country556 target enrollmentJuly 6, 2021

ConditionsPlaque Psoriasis

InterventionsBAT2206 Stelara (EU-sourced)

DrugsBAT2206 Stelara (EU-sourced)

Overview

Phase: Phase 3
Intervention: BAT2206
Conditions: Plaque Psoriasis
Sponsor: Bio-Thera Solutions
Enrollment: 556
Locations: 1
Primary Endpoint: PASI
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2021

End Date

July 7, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bio-Thera Solutions

Responsible Party

Sponsor

Eligibility Criteria

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:
•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.

Exclusion Criteria

•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.

Arms & Interventions

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.

Intervention: 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.

Intervention: Stelara (EU-sourced)

Outcomes

Primary Outcomes

PASI

Time Frame: 0-12 weeks

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

Secondary Outcomes

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)