| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Moderate to Severe Plaque Psoriasis |
|
| E.1.1.1 | Medical condition in easily understood language |
| Moderate to Severe Plaque Psoriasis |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10071117 |
| E.1.2 | Term | Plaque psoriasis |
| E.1.2 | System Organ Class | 100000004858 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
To evaluate efficacy, pharmacokinetics (PK), quality of life (QoL), and
overall safety including immunogenicity up to Week 52. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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 and bland moisturizers/emollients
(without urea or beta or alpha hydroxy acids) are also allowed for treatment of psoriasis, but these should not be used in the mornings of
study visits when efficacy assessments are going to be performed.
• Ultraviolet A phototherapy (with or without oral psoralen) or ultraviolet B phototherapy for the treatment of psoriasis within 4 weeks
prior to the first administration of the study drug (Day 1)
• Any systemic steroids or nonbiologic systemic therapies that could affect psoriasis within 4 weeks prior to the first administration of the
study drug (Day 1)
• Any investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to the first administration of the study drug (Day 1)
• Initiation or dose modification of drugs that may aggravate psoriasis (e.g., beta-blockers, lithium, antimalarials) within 4 weeks prior to the
first administration of the study drug (Day 1). Patients who have been on stable dose without exacerbation of psoriasis for at least 4 weeks
prior to the first administration of the study drug (Day 1) can be enrolled, however, the same dose should remain throughout the study.
• Herbal treatment within 2 weeks prior to the first administration of the study drug (Day 1)
Please refer protocol section 4.1.2 for rest of the criterias. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy endpoint will be the mean percent improvement from baseline in PASI score at Week 12. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | 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 |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Weeks 0, 2, 4, 8, 12, 16, 28, 40, and 52. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 21 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Korea, Republic of |
| Ukraine |
| Estonia |
| Poland |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of the study is defined as the date that the final database lock with no further database change for the final CSR. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 18 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 18 |
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