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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions

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.