Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Peking university people' s hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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.
Drug: - BAT2306
150 mg/1 ml/injection (2 injections/visit)
Drug: - EU-approved Cosentyx
150 mg/1 ml/injection (2 injections/visit)