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
Overview
- Phase
- Phase 3
- Intervention
- BAT2306
- Conditions
- Plaque Psoriasis
- Sponsor
- Bio-Thera Solutions
- Enrollment
- 502
- Locations
- 1
- Primary Endpoint
- Psoriasis Area and Severity Index (PASI)
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: BAT2306
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.
Intervention: EU-approved Cosentyx
Outcomes
Primary Outcomes
Psoriasis Area and Severity Index (PASI)
Time Frame: 0-8 weeks(EMA, PMDA) or 0-12 weeks(FDA, NMPA)
* 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.
Secondary Outcomes
- PASI-50/75/90/100(Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44)
- Psoriasis Area and Severity Index (PASI) score(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)