Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patientswith Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-004504-33-BG
- Lead Sponsor
- Bio-Thera Solutions, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 556
1. Male or female aged = 18 years with a diagnosis of plaque-type psoriasis 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. sPGA = 3, and
c. BSA affected by chronic plaque-type psoriasis = 10%
3. Failed to respond to, have a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate, or PUVA
4. Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions throughout the study period and continuing for at least 15 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 15 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 445
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 111
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(eg, eczema)that would interfere with evaluations of the effect of investigational product on psoriasis
2.Have previously received ustekinumab,a biosimilar of ustekinumab,or any drug that targets interleukin-12, interleukin-17 or interleukin-23
3.Weight >120 kg
4.Have received any monoclonal antibody-based biologic drugs for the treatment of Psoriasis(PsO)or Psoriatic arthritis(PsA)other than those prohibited (see exclusion #2)within 5 half-lives of the drugs before the screening visit
5.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 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. 7.Have received ultraviolet (UV) A phototherapy(with or without oral psoralen),UVB phototherapy,any systemic steroids,or nonbiological drugs(such as methotrexate, apremilast,sulfasalazine, azathioprine,JAK inhibitors,or other immunosuppressive agents)for the treatment of PsO or PsA 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(in case of monoclonal antibody-based investigational drugs exclusion #4 applies)
9.Have received any herbal remedies or traditional medicines used to treat psoriasis or PsA within 4 weeks before baseline visit
10.Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may confound the evaluation of the effect of
the study treatment.Patients with concurrent PsA 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.Have received a live vaccination within 4 weeks before the baseline visit(1 year before initiating treatment for Bacillus Calmette–Guerin vaccines). (Patient must agree not to receive a live vaccination during the study and up to 15 weeks [1 year for Bacillus Calmette–Guerin vaccines] after the last dose of the study drug).COVID-19 vaccination will not be allowed for 4 weeks before randomization or for 2 weeks before each dosing (Week 4,Week 16, Week 28,and Week 40)during the study
13.Have clinical signs or symptoms consistent with coronavirus disease 2019 (COVID-19)infection within the last 4 weeks before screening or during screening. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required.
14.History of invasive infection
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 makes the patient unsuitable for the study,including recurrent/disseminated herpes zoster
17.Meet criteria relative to latent or active tuberculosis infection as described in the protocol
18.Presence of any of the abnormal laboratory test results at screening as described in the protocol
19.Positive HIV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method