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

NCT05377944 | Completed Phase 3

• 1 other identifier: BAT-2306-002-CR
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Psoriasis Area and Severity Index (PASI) score

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

• PASI-50/75/90/100

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

• Investigator's Global Assessment (IGA)

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

Study Arms (2)

BAT2306

EXPERIMENTAL

Patients 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.

Drug: BAT2306

EU-approved Cosentyx

ACTIVE COMPARATOR

Patients 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.

Drug: EU-approved Cosentyx

Interventions

BAT2306 DRUG

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

Also known as: Recombinant human monoclonal antibody against IL-17A

BAT2306

EU-approved Cosentyx DRUG

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

Also known as: secukinumab injection

EU-approved Cosentyx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

secukinumab

Study Officials

• Min Zheng

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: October 26, 2022
• Primary Completion: May 24, 2024
• Study Completion: December 10, 2024
• Last Updated: April 23, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)