Moderate to Severe Chronic Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: SOC Classification code 10040785 Term: Skin and subcutaneous tissue disorders System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Dong-A ST Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged =18 and =75 years at time of screening. 2. Patients with body weight =140 kg. 3. Patients who have a diagnosis of plaque-type psoriasis for at least 6 months prior to IP initiation. 4. Patients with moderate to severe psoriasis defined by PASI score of 12 or greater, Physician Global Assessment (PGA) score of 3 or greater and body surface area (BSA) affected by plaque-type psoriasis of 10% or greater at screening and baseline. 5. Patients who are considered by the treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis. 6. Patients who previously had an inadequate response, intolerance to, or contraindication to at least 1 conventional anti-psoriatic systemic therapy Other protocol-defined inclusion criteria could apply 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 510 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to ustekinumab or any of the product excipients (for either DMB-3115 or Stelara). 2. Patients with non-plaque forms of psoriasis including guttate, erythrodermic, inverse or pustular types or drug induced psoriasis. 3. Patients who have received: - any biological therapeutic agents targeted at inhibiting IL-12 or IL-23, inhibiting IL-17, or integrin. - any biological therapeutic agents for psoriasis within past 90 days or within 5 drug half-lives prior to screening, whichever is longer. - any monoclonal antibodies within 9 months prior to screening. - any other investigational drugs within 5 half-lives of the investigational treatment prior to IP initiation. - phototherapy, photochemotherapy, or non-biological systemic treatment for psoriasis within 4 weeks prior to IP initiation. - topical treatment that is likely to impact signs and symptoms of psoriasis within 2 weeks prior to IP initiation. - topical treatment for psoriasis under investigation within 4 weeks prior to IP initiation. 4. Patients with previous use of 2 or more biologics for treatment of psoriasis. 5. Patients who have allergic reaction or hypersensitivity to previous biological treatments. 6. Patients who have an active ongoing inflammatory disease other than psoriasis that might confound the evaluation of treatment with ustekinumab. 7. Patients who have an active infection or history of infections as follows: - any active infection for which systemic anti-infectives were used within 4 weeks prior to IP initiation - a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to IP initiation - recurrent or chronic infections or other active infection 8. Patients who have a laboratory-confirmed COVID-19 test or have been in close physical contact (6 feet or closer for at least 15 minutes) with a person who is known to have laboratory confirmed COVID-19 or with anyone who has any symptoms consistent with COVID-19 within the past 14 days. 9. Patients with a known infection with human immunodeficiency virus, hepatitis B, or hepatitis C. 10. Patients who have an uncontrolled, clinically significant systemic disease 11. Patients with a prior malignancy within 5 years 12. Patients who have neurologic symptoms suggestive of central nervous system demyelinating disease. 13. Patients who have received a live or live-attenuated vaccination within 6 weeks prior to the first administration of the IP 14. Patients who have had Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to the first administration of the IP. Patients must agree not to receive a BCG vaccination during the study and up to 1 year after the last dose of the IP. 15. Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection. 16. Patients with history or symptoms of active tuberculosis 17. Patients with a history of alcohol or substance abuse within 6 months prior to screening 18. Patients taking medications known to worsen psoriasis Other protocol-defined exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of DMB-3115.;Secondary Objective: To evaluate safety, tolerability, PK, and immunogenicity of DMB-3115.;Primary end point(s): Percent change in the Psoriasis Area and Severity Index (PASI) score from baseline to Week 8;Timepoint(s) of evaluation of this end point: At week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients with a PASI 50, 75, 90, 100 response - Percentage change in AUEC for the PASI score from baseline - Percent change in the PASI score from baseline - Percentage of patients with a Physician's Global Assessment (PGA) score of Cleared or Minimal - Change from baseline in Dermatology Life Quality Index (DLQI) Safety Endpoint: - Incidence of AEs, SAEs, including incidence of injection site reactions, changes in vital signs, laboratory abnormalities. Immunogenicity Endpoint: - Incidence of anti-drug antibodies (ADA). Pharmacokinetic Endpoint: - Drug concentrations at various timepoint - Pharmacokinetic parameters after the first-dose;Timepoint(s) of evaluation of this end point: At different timepoints as defined in the protocol | — |
Countries
Bulgaria, Czechia, Czech Republic, Estonia, Georgia, Hungary, Latvia, Poland, Russian Federation, Ukraine, United States
Contacts
Public ContactProject Management
IQVIA
Outcome results
None listed