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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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). 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.

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 the treatment of autoimmune disease 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 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 corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline visit.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05377944
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bio-Thera Solutions
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jianzhong Zhang
Principal Investigator Affiliation Peking university people' s hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: BAT2306

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.

Active Comparator: EU-approved Cosentyx

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.

Interventions

Drug: - BAT2306

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

Drug: - EU-approved Cosentyx

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Longxun Jin

[email protected]

+8613580506307

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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