Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Product Code: CT-P43
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit:
Sponsors
Celltrion, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female aged 18 to 80 years old, both inclusive. 2. Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks before the first administration of the study drug (Day 1). 3. Patient has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis (PsA) at both Screening and at the time of the first administration of the study drug (Day 1) as defined by the following: a PASI score of =12 and an involved body surface area (BSA) =10% and a static Physician's Global Assessment (sPGA) score of =3 4. Patient is a candidate for phototherapy or systemic therapy. 5. Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results: • Serum creatinine =1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (SI [Système International d'Unités] units: 0.84 mL/s) • Serum alanine aminotransferase or aspartate aminotransferase =2.5 × ULN • Serum total bilirubin =1.5 × ULN 6. Patient has the following hematology laboratory test results at Screening: • Hemoglobin =10.0 g/dL (SI units: >100 g/L or 6.21 mmol/L) • Absolute neutrophil count =1.5 × 10^3 cells/µL (SI units: =1.5 × 10^9 cells/L) • Platelet count =100 × 10^3 cells/µL (SI units: =100 × 10^9 cells/L) 7. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, and signs and dates the written informed consent before participation in the study. 8. Female patient who is considered of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use highly effective methods of contraception consistent with local regulations during the course of the study and at least 15 weeks following discontinuation of study drug (excluding women who are not of childbearing potential). Examples include the following: • Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation • Intrauterine device or intrauterine hormone-releasing system • True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. Male patient who is sexually active with a woman of childbearing potential must agree to use the highly effective method described as above or medically acceptable methods of contraception (e.g., male or female condom AND additional hormonal or barrier method by female partner) consistent with local regulations during the study and for 15 weeks following discontinuation of study drug. If patient or their partner has been surgically sterilized for less than 24 weeks prior to the date of informed consent form (ICF), they also must agree to use method(s) of contraception as described above. Postmenopausal female patients must have experienced their last menses more than 1 year prior to the date of ICF without an alternative medical cause to be classified as not of childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F
Exclusion criteria
Exclusion criteria: 1. Patient diagnosed with forms of psoriasis other than plaque-type such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema) at the time of the Screening visit that would interfere with evaluations of the effect of investigational product on psoriasis. 2. Patient previously received ustekinumab or a biosimilar of stekinumab or any drug that targets directly interleukin (IL)-12, or IL-23. 3. Patient who has prior exposure to 2 or more biologic agents approved for the treatment of psoriasis. Patient with 1 prior biologics can be enrolled after sufficient wash-out period of 12 weeks or 5 half-lives (whichever is longer) prior to the first administration of the study drug (Day 1) (see Exclusion criteria 11 for other prohibited medications or treatment). 4. Patient who has current or chronic inflammatory or autoimmune disease or symptoms other than psoriasis and psoriatic arthritis that might confound study evaluations. Patient with PsA will be allowed to participate. 5. Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex. 6. Patient who has received a live or live-attenuated vaccination within 4 weeks prior to the first administration of the study drug (Day 1). Patient must agree not to receive a live or live-attenuated vaccines during the study and at least 15 weeks after the last dose of the study drug. 7. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to the first administration of the study drug (Day 1). Patients must agree not to receive a BCG vaccination during the study and up to 1 year after the last dose of the study drug. 8. Patient who has a current or past history of any of the following infections: • Current or past history of infection with human immunodeficiency virus (HIV) or current infection with hepatitis B or hepatitis C. However, a patient with past hepatitis B or C virus infection is allowed if resolved. • Current or past history of serious infection requiring hospitalization or parenteral injection of antibiotics within 8 weeks prior to the first administration of the study drug (Day 1). • Herpes zoster infection within 8 weeks prior to the first administration of the study drug (Day 1). • Current or past granulomatous infections or other severe or chronic or recurrent infections (such as sepsis, abscess or opportunistic infections, or invasive fungal infections such as histoplasmosis or nontuberculous mycobacterial infection or infected skin wounds or ulcer). However, a patient who has a past diagnosis with sufficient documentation of complete resolution of the infection can be enrolled in the study. 11. Patient who has received or plans to receive any of the following prohibited medications or treatment that could affect psoriasis: • Topical therapies for the treatment of psoriasis (including, but not limited to, corticosteroids, vitamin D analogs, calcineurin inhibitors or retinoids) within 2 weeks prior to the first administration of the study drug (Day 1). However, low-potency topical corticosteroids (Class 6 or 7) applied to the face and intertriginous areas are permitted during study participation to reduce patient's burden with a restriction of use within 12 hours prior to study visits requiring PASI or sPGA measures. Shampoos with salicylic acids a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that CT-P43 is equivalent to Stelara, in terms of efficacy as determined by the mean percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12.;Secondary Objective: To evaluate efficacy, pharmacokinetics (PK), quality of life (QoL), and overall safety including immunogenicity up to Week 52.;Primary end point(s): The primary efficacy endpoint will be the mean percent improvement from baseline in PASI score at Week 12.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints will be assessed during the study. • The PASI scores at Weeks 0, 2, 4, 8, 12, 16 , 28, 40, and 52 • The mean percent improvement from baseline in PASI score at Weeks 2, 4, 8, 16, 28, 40, and 52 • The proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100) at Weeks 2, 4, 8, 12, 16, 28, 40, and 52 • The proportion of patients with sPGA score on a 5-point scale of clear (0) or almost clear (1) at Weeks 0, 2, 4, 8, 12, 16, 28, 40, and 52 • The change in Dermatology Life Quality Index (DLQI) score from baseline at Weeks 2, 4, 8, 12, 16, 28, 40, and 52;Timepoint(s) of evaluation of this end point: Weeks 0, 2, 4, 8, 12, 16, 28, 40, and 52. | — |
Countries
Estonia, Korea, Republic of, Poland, Ukraine
Contacts
Public ContactYun Ju Bae
Celltrion, Inc.
Outcome results
None listed