Clinical Trials Register

Summary
EudraCT Number:	2022-001770-59
Sponsor's Protocol Code Number:	BAT-2306-002-CR
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-07-28
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2022-001770-59

A.3

Full title of the trial

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

Multicentrikus, randomizált, kettős vak, párhuzamos kar elrendezésű, III. fázisú vizsgálat a BAT2306 és a Cosentyx® hatásosságának és biztonságosságának összehasonlítására középsúlyos vagy súlyos plakkos pikkelysömörben szenvedő betegeknél

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparison of the efficacy and safety between two study drugs in skin disease patients

A.4.1

Sponsor's protocol code number

BAT-2306-002-CR

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05377944

A.5.4

Other Identifiers

Name:

China IND

Number:

CXSL2000344

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bio-Thera Solutions, Ltd.
B.1.3.4	Country	China
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bio-Thera Solutions, Ltd.
B.4.2	Country	China
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bio-Thera Solutions, Ltd.
B.5.2	Functional name of contact point	Xiaolei Yang
B.5.3	Address:
B.5.3.1	Street Address	Floor 5, Building A6, Science Enterprise Accelerator, 11 Kaiyuan Avenue, Science City
B.5.3.2	Town/ city	Huangpu District, Guangzhou, Guangdong Province
B.5.3.3	Post code	510530
B.5.3.4	Country	China
B.5.4	Telephone number	+8613538941739
B.5.6	E-mail	xlyang@bio-thera.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Recombinant human monoclonal IgG1 antibody
D.3.2	Product code	BAT2306
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant human monoclonal IgG1 antibody
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	BAT2306
D.3.9.3	Other descriptive name	Secukinumab
D.3.9.4	EV Substance Code	SUB33242
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cosentyx®
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cosentyx 150 mg solution for injection in pre-filled syringe
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.4	EV Substance Code	SUB33242
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate to Severe Plaque Psoriasis

E.1.1.1

Medical condition in easily understood language

It is an autoimmune diseas characterized by raised areas of abnormal skin. These areas are red, or purple on some people with darker skin, dry, itchy, and scaly.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10021428
E.1.2	Term	Immune system disorders
E.1.2	System Organ Class	10021428 - Immune system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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

E.2.2

Secondary objectives of the trial

- 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.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female aged ≥ 18 years with a diagnosis of plaque-type psoriasis at least 24 weeks before screening.
2. 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%
3. Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
a. topical treatment and/or
b. phototherapy and/or
c. previous systemic therapy.
4. Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions throughout the study period and continuing for at least 20 weeks after the last dose of study drug.
5. If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits.
6. Must be willing to provide written consent and to comply with the requirements of the study protocol.

E.4

Principal 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.
3. Weight > 120 kg.
4. Have received any monoclonal antibody-based biologic drugs for treatment of autoimmune disease or with a potential effect on the study condition other than those prohibited within 5 half-lives or 6 months, whichever is longer, before the screening visit.
5. Have received non-monoclonal antibody biological drugs for the treatment of PSO or PsA within 12 weeks or 5 half-lives (whichever is longer) before the screening visit.
6. Have received topical therapies for the treatment of psoriasis (such as but not limited to corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline visit.
7. Have received phototherapy such as ultraviolet (UV) A phototherapy (with or without oral psoralen), UVB phototherapy, or any systemic steroids, or nonbiological drugs for treatment of autoimmune disease or with a potential effect on the study condition (such as but not limited to methotrexate, apremilast, acitretin, tofacitinib, sulfasalazine, or cyclosporine) within 4 weeks before baseline visit.
8. Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before the screening visit.
9. Have received any herbal remedies or traditional medicines used to treat psoriasis within 4 weeks before baseline visit.
10. Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may affect patient’s safety or efficacy assessment.
11. History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex.
12. Plan to receive any live vaccination after screening and during the study period (Patient must agree not to receive a live vaccination during the study), or with any Covid-19 vaccination within 2 weeks prior to baseline visit.
13. Have clinical signs or symptoms consistent with coronavirus disease 2019 (COVID-19) infection, e.g., fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test (done at the discretion of investigator or per local regulation) within the last 4 weeks before screening or during screening. Resolution of confirmed infection is defined as a negative appropriate COVID-19 laboratory test (as per local regulation) or at least 4 weeks since recovery from symptoms in those symptomatic or at least 4 weeks without any symptom after a positive COVID-19 test in those asymptomatic.
14. History of invasive infection (e.g., histoplasmosis, coccidioidomycosis, blastomycosis).
15. 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.
16. Any recurrent bacterial, fungal, or viral infection that (based on the investigator’s clinical assessment) makes the patient unsuitable for the study, including recurrent/disseminated herpes zoster.
17. Meet any of the criteria relative to latent or active TB infection listed in the protocol.
18. Presence of any abnormal laboratory test results at screening as detailed in the protocol.
19. Positive HIV, hepatitis B, or hepatitis C serological result.
20. Evidence of malignancy, lung infection, or abnormalities suggestive of active TB on chest radiography (x-ray or computed tomography) performed within 12 weeks before the screening visit or during the screening period.
21. Significant medical problems as defined in the protocol.
22. Any history of malignancy or lymphoproliferative disease at any time, except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
23. Have a transplanted organ/tissue or stem cell transplantation.
24. Have an underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of the investigator places the patient at unacceptable risk.
25. With or have a history of inflammatory bowel diseases.
26. Have a history of demyelinating diseases or neurologic symptoms suggestive of demyelinating disease.
27. Any major surgical procedure within 12 weeks of the baseline visit or planned during the study.
28. Patient is not willing to limit UV light exposure during the study.
29. Pregnant or breastfeeding (lactating) women.

Please refer to protocol for complete list of exclusion criteria.

E.5 End points

E.5.1

Primary end point(s)

Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8 .

E.5.1.1

Timepoint(s) of evaluation of this end point

per protocol

E.5.2

Secondary end point(s)

Percentage change from baseline in PASI score at Weeks 2, 4, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Change from baseline in PASI score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Area under the effect curve (AUEC) for PASI from baseline to Weeks 8, 12, and 24

Change from baseline in Investigator’s Global Assessment (IGA mod 2011) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Proportion of patients with IGA score of cleared (0) or minimal (1) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Change from baseline in affected body surface area at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Change from baseline in Dermatology Life Quality Index (DLQI) score to Weeks 2, 4, 8, 12, 24, 32 and 44

E.5.2.1

Timepoint(s) of evaluation of this end point

per protocol

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

quality of life, immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

China

Japan

Poland

Hungary

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

290

F.4.2.2

In the whole clinical trial

500

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-11

P. End of Trial
P.	End of Trial Status	Ongoing

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