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Plaque PsoriasisPhase 3NCT05377944

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

A Phase 3 study testing BAT2306 and EU-approved Cosentyx in people with Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
BAT2306 and EU-approved Cosentyx
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
1 siteChina
Study dates
26 Oct 2022to 10 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • PASI ≥ 12,
  • IGA ≥ 3 (based on a scale of 0-4), and
  • BSA affected by chronic plaque-type psoriasis ≥ 10%
  • Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
Show all 12Show fewer
  • topical treatment and/or
  • phototherapy and/or
  • previous systemic therapy.
  • 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).
  • 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.

Who cannot join

  • 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.
  • Have previously received secukinumab, a biosimilar of secukinumab, or any drug that targets interleukin-17 or the IL-17 receptor (eg, ixekizumab, brodalumab).
  • Weight > 120 kg.
  • 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.
  • 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.
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: 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

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.

Read the 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.
Being tested
BAT2306, EU-approved Cosentyx

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT2306Drug

    Also called Recombinant human monoclonal antibody against IL-17A

    150 mg/1 ml/injection (2 injections/visit)

  • EU-approved CosentyxDrug

    Also called secukinumab injection

    150 mg/1 ml/injection (2 injections/visit)

Study groups in NCT05377944
Study groupRoleWhat they receive
BAT2306ExperimentalPatients will receive subcutaneous treatment of 300 mg BAT2306 (2 injections of 150 mg/1 ml) via PFS at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.
Receives: Drug: BAT2306
EU-approved CosentyxActive comparatorPatients will receive subcutaneous treatment of 300 mg EU-approved Cosentyx (2 injections of 150 mg/1 ml) at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40.
Receives: Drug: EU-approved Cosentyx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psoriasis Area and Severity Index (PASI)

    • EMA, PMDA, and Agencies other than the FDA and NMPA: Percent change from baseline in Psoriasis Area and Severity Index (PASI) score to Week 8
    • FDA and NMPA: Percent change from baseline in PASI score to Week 12

    Minimum value 0, maximum value 72. Higher score means worse outcome.

    Measured: 0-8 weeks(EMA, PMDA) or 0-12 weeks(FDA, NMPA)

Secondary outcomes (3)

  1. Psoriasis Area and Severity Index (PASI) score

    Percentage change from baseline in PASI score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44. Minimum value 0, maximum value 72. Higher score means worse outcome.

    Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

  2. PASI-50/75/90/100

    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.

    Higher score means better outcome

    Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

  3. Investigator's Global Assessment (IGA)

    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. Minimum value 0, maximum value 4. Higher score means worse outcome.

    Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start26 Oct 2022
  3. Primary completion24 May 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377944
Sponsor's protocol ID
BAT-2306-002-CR
Status last verified
Oct 2024
First submitted
12 May 2022
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen JQ, Chen R, Wu L, Ding Y, Kaszuba A, Tanizaki H, Yang X, Jin L, Dong Q, Zheng M, Man XY. Secukinumab biosimilar BAT2306 versus reference secukinumab in patients with moderate-to-severe plaque psoriasis: a multicentre, double-blind, randomised, active-controlled, phase 3 trial. Lancet Rheumatol. 2026 Sep;8(9):e727-e736. doi: 10.1016/S2665-9913(26)00118-9. Epub 2026 Jun 29.

    PubMed 42372782

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAT2306 and EU-approved Cosentyx in people with Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psoriasis Area and Severity Index (PASI) (time frame: 0-8 weeks(EMA, PMDA) or 0-12 weeks(FDA, NMPA)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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