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Clinical Trial Results:
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

Summary
EudraCT number	2022-001770-59
Trial protocol	HU
Global end of trial date	24 May 2024

Results information
Results version number	v1(current)
This version publication date	20 Jun 2025
First version publication date	20 Jun 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BAT-2306-002-CR

ISRCTN number

US NCT number

NCT05377944

WHO universal trial number (UTN)

Other trial identifiers

China IND: CXSL2000344

Sponsor organisation name

Bio-Thera Solutions, Ltd.

Sponsor organisation address

Floor 5, Building A6 Science Enterprise Accelerator 11 Kaiyuan Avenue, Science City Huangpu District, Guangzhou, China, 510530

Public contact

Xiaolei Yang, Bio-Thera Solutions, Ltd., +86 13538941739, xlyang@bio-thera.com

Scientific contact

Xiaolei Yang, Bio-Thera Solutions, Ltd., +86 13538941739, xlyang@bio-thera.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Jul 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

27 Jul 2023

Global end of trial reached?

Yes

Global end of trial date

24 May 2024

Was the trial ended prematurely?

Main objective of the trial

To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis.

Protection of trial subjects

This study was conducted in accordance with the accepted version of the Declaration of Helsinki in compliance with ICH GCP guidelines, and according to the appropriate regulatory requirements in the countries where the study was conducted. The clinical study protocol, protocol amendments, informed consent forms (ICFs), and any other appropriate study-related documents were reviewed and approved by independent ethics committees(IECs) and institutional review boards (IRBs) for each study center. Before entering the study, the investigator (or designee) explained to each subject (or their legally acceptable representatives, if applicable) the nature of the study, its purpose, procedures, expected duration, alternative therapy available, and the benefits and risks involved in study participation. Subjects were given written information about the study, and, before any study procedures were performed, each subject voluntarily signed and dated the ICF.

Background therapy

Evidence for comparator

Secukinumab (Cosentyx®) is a human IgG1 monoclonal antibody developed by Novartis. Secukinumab can inhibit IL-17 receptor via selectively binding to IL-17A, to inhibit its interaction with the IL-17 receptor and thus inhibiting the release of pro-inflammatory cytokines and chemokines. Cosentyx® has been marketed overseas in 2014 with approved indications such as moderate to severe plaque psoriasis (in adults who are candidates for systemic therapy or phototherapy [EU label for candidates of systematic therapy only]), psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Secukinumab has been marketed in China in March 2019 under the trade name of Cosentyx, and its approved indications are psoriasis and ankylosing spondylitis

Actual start date of recruitment

13 Oct 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 112

Country: Number of subjects enrolled

Hungary: 65

Country: Number of subjects enrolled

China: 265

Country: Number of subjects enrolled

Japan: 60

Worldwide total number of subjects

502

EEA total number of subjects

177

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

451

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects were screened from 2022.Oct.13 to 2023.May.15. First patient was randomized on 2022.Oct.26 and Last patient was randomized on 2023.May.31 Subjects were recruited from Poland, Hungary, China and Japan.

Screening details

Patients should have moderate to severe plaque-type psoriasis as defined at screening and baseline by: a. PASI ≥ 12, b. IGA ≥ 3 (based on a scale of 0-4), and c. BSA affected by chronic plaque-type psoriasis ≥ 10%

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

BAT2306

Arm description

Arm type

Experimental

Investigational medicinal product name

BAT2306 Injection

Investigational medicinal product code

BAT2306

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg (2 injections of 150 mg/1 ml) of BAT2306 or Cosentyx via PFS will be subcutaneously administered at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.

Cosentyx

Arm description

Arm type

Active comparator

Investigational medicinal product name

EU-approved Cosentyx

Investigational medicinal product code

Cosentyx

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

300 mg (2 injections of 150 mg/1 ml) of BAT2306 or Cosentyx via PFS will be subcutaneously administered at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.

Number of subjects in period 1	BAT2306	Cosentyx
Started	252	250
Completed	234	223
Not completed	18	27
Physician decision	1	2
Consent withdrawn by subject	12	17
Adverse event, non-fatal	-	3
Pregnancy	1	-
Imprisoned	-	1
Poor patient compliance	-	1
Lost to follow-up	3	3
Lack of efficacy	1	-

Baseline characteristics

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Reporting group title

BAT2306

Reporting group description

Reporting group title

Cosentyx

Reporting group description

Reporting group values	BAT2306	Cosentyx	Total
Number of subjects	252	250	502
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	228	223	451
From 65-84 years	24	27	51
85 years and over	0	0	0
Gender categorical
Units: Subjects
Female	70	73	143
Male	182	177	359

End points

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Reporting group title

BAT2306

Reporting group description

Reporting group title

Cosentyx

Reporting group description

Subject analysis set title

BAT2306 TP1

Subject analysis set type

Intention-to-treat