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Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 With Cosentyx® in Patients With Moderate to Severe Plaque Psoriasis

NCT05377944•Bio-Thera Solutions

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Primary objective: • To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis. Secondary objectives: * To evaluate the efficacy of BAT2306 compared with Cosentyx over the study period based on secondary efficacy endpoints. * To evaluate the safety and tolerability of BAT2306 compared with Cosentyx over the study period. * To evaluate the immunogenicity of BAT2306 compared with Cosentyx over the study period. * To evaluate the steady-state pharmacokinetics (PK) of BAT2306 compared with Cosentyx. * To assess safety and immunogenicity after transition from Cosentyx to BAT2306.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥ 18 years old with a diagnosis of plaque-type psoriasis for at least 24 weeks before screening.
•2. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
•1. PASI ≥ 12,
•2. IGA ≥ 3 (based on a scale of 0-4), and
•3. BSA affected by chronic plaque-type psoriasis ≥ 10%
•3. Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
•1. topical treatment and/or
•2. phototherapy and/or
•3. previous systemic therapy.
•4. 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).
+2 more criteria

Exclusion Criteria

•1. 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 (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
•2. Have previously received secukinumab, a biosimilar of secukinumab, or any drug that targets interleukin-17 or the IL-17 receptor (eg, ixekizumab, brodalumab).
•3. Weight \> 120 kg.
•4. Have received any monoclonal antibody-based biologic drugs for the treatment of PsO or PsA or with a potential effect on the study condition, other than those prohibited (see exclusion #2) within 5 half-lives or 6 months, whichever is longer, before baseline visit.
•5. Have received non-monoclonal antibody biological drugs (eg, etanercept) for the treatment of PsO or PsA within 12 weeks or 5 half-lives (whichever is longer) before baseline visit.
•6. Have received topical therapies for the treatment of psoriasis (such as corticosteroids, vitamin D analogs, retinoids, herbal or non-pharmacological topical preparations other than moisturizers or emollients) within 2 weeks before baseline visit.
•And so on

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

October 26, 2022

Primary Completion Date

May 24, 2024

Completion Date

December 10, 2024

Last Updated

April 23, 2025

Enrollment

502

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

BAT2306

DRUG

EU-approved Cosentyx

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

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RECRUITINGPHASE3

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis