A Study to Compare Efficacy and Safety of BAT2306 with Cosentyx in Patients with Moderate to Severe Plaque Psoriasis

JRCT ID: jRCT2051220123

Registered date:29/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Moderate to Severe Plaque Psoriasis
• Date of first enrollment: 07/02/2023
• Target sample size: 60
• Countries of recruitment: China,Japan,Poland,Japan,Hungary,Japan
• Study type: Interventional
• Intervention(s): 300 mg (2 injections of 150 mg/1 ml) of BAT2306 or Cosentyx via prefilled syringe will be subcutaneously administered at weeks 0, 1, 2, 3, and 4 followed by dosing every 4 weeks, thereafter up to Week 40. Patients randomized to receive BAT2306 during treatment period (TP) 1 will continue to receive the same drug during TP2. Patients randomized to receive Cosentyx during TP1 may either receive BAT2306 or Cosentyx in TP 2 on the basis of the randomization performed at the beginning of TP2 (Week 24 visit).

Outcome(s)

Primary Outcome

The primary efficacy endpoint is dependent on the Regulatory Agency to be submitted to, as follows:
- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Each patient must meet all of the following criteria to be enrolled in this study:
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:
a. PASI >= 12,
b. IGA >= 3 (based on a scale of 0-4), and
c. BSA affected by chronic plaque-type psoriasis >= 10%
3. Candidates for systemic therapy, defined as having chronic plaque-type psoriasis considered inadequately controlled by:
a. topical treatment and/or
b. phototherapy and/or
c. 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. 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.

Exclude criteria

Patients meeting any of the following criteria will be excluded from the study:
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, medicationinduced 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 (e.g. ixekizumab, brodalumab).
3. Weight > 120 kg.
4. Have received any monoclonal antibody-based biologic drugs for 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.
5. Have received non-monoclonal antibody biological drugs (e.g. etanercept) for the treatment of PSO or PSA within 12 weeks or 5 half-lives (whichever is longer) before baseline visit.
6. Have received topical therapies for the treatment of psoriasis (such as but not limited to corticosteroids, vitamin D analogs, retinoids, herbal or non-pharmacological topical preparations other than moisturizers or emollients) within 2 weeks before baseline visit.
7. Have received phototherapy such as ultraviolet (UV) A phototherapy (with or without oral psoralen), UVB phototherapy, or any systemic steroids, or nonbiological drugs for treatment of PsO or PsA or with a potential effect on the study condition (such as but not limited to methotrexate, apremilast, acitretin, tofacitinib, upadacitinib, sulfasalazine, or cyclosporine) within 4 weeks before baseline visit.
8. Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before the screening visit.
9. Have received any herbal remedies or traditional medicines for systemic use used to treat psoriasis within 4 weeks before baseline visit.
10. Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may affect patients' safety or study assessment. Patients with concurrent psoriatic arthritis will be allowed to participate.
11. History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex.
12. Plan to receive any live vaccination after screening and during the study period (Patient must agree not to receive a live vaccination during the study), or with any Covid-19 vaccination within 2 weeks prior to baseline visit.
13. Have clinical signs or symptoms consistent with COVID-19 infection, e.g. fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks before Screening or during Screening. Resolution of confirmed infection is defined as a negative appropriate COVID-19 laboratory test or at least 4 weeks since recovery from symptoms in those symptomatic or at least 4 weeks without any symptom after a positive COVID-19 test in those asymptomatic.
14. History of invasive infection (e.g. histoplasmosis, coccidioidomycosis, blastomycosis).
15. Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization <= 8 weeks before baseline visit or oral antibiotics <=2 weeks before baseline visit. Minor fungal infections may be allowed.
16. Any recurrent bacterial, fungal, or viral infection that, (based on the investigator's clinical assessment), makes the patient unsuitable for the study, including recurrent/disseminated herpes zoster.
17. Meet any of the following criteria relative to latent or active tuberculosis (TB) infection:
a. Current or history of active TB
b. Presence of signs or symptoms suggestive of active TB upon medical history and/or physical examination during screening.
c. Positive IGRA result at screening. If a patient's initial IGRA test result is indeterminate, the test can be repeated once. If the test result is again indeterminate (or positive), the patient will be excluded from the study. An exception for positive results may be made for : i) patients who have documentation of having completed appropriate standard treatment for latent TB within 5 years prior to first dose of the study drug as confirmed by a TB specialist/pulmonologist and have not been exposed to increased risk of TB infection since then, and do not have radiologic findings or physical evidence supporting active TB; or ii) patients testing positive for latent TB who have been receiving anti-tuberculosis prophylactic treatment for at least 4 weeks prior to the first dose of the study drug, and are willing to continue to complete prophylactic treatment as per local guidelines.
18. Presence of any of the following abnormal laboratory test results at screening:
a. Abnormal liver function defined as aspartate aminotransferase and/or alanine aminotransferase > 1.5 x upper limit of normal (ULN) (if the initial result is exclusionary, the test may be repeated once if the patient has no known history of liver disease).
b. Serum total bilirubin > 1.5 x ULN, unless there is a documented history of Gilbert syndrome (if the initial result is exclusionary, the test may be repeated once if the patient has no known history of liver disease).
c. Abnormal renal function defined as serum creatinine level >= 1.5 x ULN.
d. Total white blood cell count <= 3000/microL, absolute neutrophil count <= 2000/microL, platelet count < 100,000/microL, or hemoglobin < 8.5 g/dL.
19. Positive HIV, hepatitis B, or hepatitis C serological result.
a. hepatitis B surface antigen-positive patients will be excluded;
b. when hepatitis B core antibody and/ or hepatitis B surface antibody is positive, the patient will be tested for HBV DNA
- If HBV DNA is negative, the patients will be included.
- If HBV DNA is positive, the patients will be excluded.
20. Evidence of malignancy, lung infection, or abnormalities suggestive of active TB on chest radiography (x-ray or computed tomography) performed within 12 weeks before the screening visit or during the screening period.
21. Significant medical problems, including (but not limited to) uncontrolled hypertension (systolic pressure >= 160 mmHg and/or diastolic pressure >= 100 mmHg), congestive heart failure (New York Heart Association status of class III or IV), history of unstable angina pectoris, myocardial infarction, or cerebrovascular accident within the past 12 months before the baseline visit, uncontrolled diabetes, or renal or liver disease.
22. Any history or concurrence of malignancy or lymphoproliferative disease at any time, except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
23. Have a transplanted organ/tissue or stem cell transplantation.
24. Have an underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of the investigator places the patient at unacceptable risk.
25. With current or have a history of inflammatory bowel diseases.
26. Have a history or concurrence of demyelinating diseases (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
27. Any major surgical procedure within 12 weeks of the baseline visit or planned during the study.
28. Patient is not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the study.
29. History of clinically significant drug or alcohol abuse within 12 months prior to the baseline visit as judged by the investigator.
30. Pregnant or breastfeeding (lactating) women.
31. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
32. Patients participating in another investigational drug or device trial or planning on participating in another clinical trial during the course of the study.

Related Information

• Primary Sponsor: Yoo EunHye
• Secondary ID(s): 2022-001770-59