| 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 | Diseases [C] - Immune System Diseases [C20] |
| 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 compare the efficacy of ABP 654 with ustekinumab in subjects with moderate to severe plaque psoriasis. |
|
| E.2.2 | Secondary objectives of the trial |
| To assess the safety and immunogenicity of ABP 654 compared with ustekinumab. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Men and women ≥ 18 years and ≤ 75 years of age at the time of randomization
2. Stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the Investigator)
3. Baseline score of PASI ≥ 12, involvement of ≥ 10% BSA, and sPGA ≥ 3 at screening and at baseline
4. Candidate for phototherapy or systemic therapy
5. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy (eg, methotrexate, cyclosporine, psoralen plus ultra-violet light [PUVA])
6. For women (except those at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
7. Signed Institutional Review Board/Ethics Committee (IRB/IEC)-approved informed consent and able to complete study procedures
8. No known history of latent or active TB. Subject must meet any 1 of the following 3 criteria:
• Subject has a negative test for tuberculosis during screening, defined as either:
o Negative purified protein derivative (PPD; < 5 mm of induration at 48 to 72 hours after test is placed) OR
o Negative Quantiferon®/T-spot test
• Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon®/T-spot®
• Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin [BCG] vaccination) or subjects with a positive or indeterminate Quantiferon®/T-spot test are allowed if they have all of the following:
o No symptoms per tuberculosis worksheet provided by the sponsor, Amgen
o Documented history of adequate prophylaxis initiation prior to receiving investigational product in accordance with local recommendations
o No known exposure to a case of active TB after most recent prophylaxis
o No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product |
|
| E.4 | Principal exclusion criteria |
Skin disease related conditions
1. Erythrodermic psoriasis (PsO), pustular PsO, guttate PsO, medication induced PsO, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on PsO
Other medical conditions
2. Subject has a planned surgical intervention during the duration of the study
3. Subject has an active infection or history of infections as follows:
a. Any active infection for which systemic anti-infectives were used within 28 days prior to randomization
b. A serious infection, defined as requiring hospitalization or intravenous antiinfectives within 8 weeks prior to randomization
c. Recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
4. Known history of human immunodeficiency virus (HIV)
5. Hepatitis B surface antigen (HbsAg) or HCV antibody positivity at screening
6. Uncontrolled, clinically significant systemic disease such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension
7. Known malignancy within the previous 5 years (except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma)
8. Active neurological disease such as multiple sclerosis, Guillain-Barre syndrome, optic neuritis, transverse myelitis or history of neurologic symptoms suggestive of central nervous system demyelinating disease
9. Moderate to severe heart failure (New York Heart Associate [NYHA] class III/IV)
10. Known hypersensitivity to the investigational product or to any of the excipients
11. Any concurrent medical condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject Laboratory abnormalities
12. Laboratory abnormalities at screening, including any of the following:
a. Hemoglobin < 9 g/dL
b. Platelet count < 100,000/mm3
c. White blood cell count (WBC) < 3,000 cells/mm3
d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 2.0 × the upper limit of normal (ULN)
e. Creatinine clearance < 50 mL/min (Cockcroft-Gault formula)
f. Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
Washouts and non-permitted drugs
13. Previous treatment with any agent specifically targeting IL-12 or IL-23
14. Received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is the longer) prior to randomization
15. Received any investigational agents within the previous month or 5 drug half-lives (whichever is the longer) prior to randomization
16. Received non-biologic systemic psoriasis therapy within 4 weeks prior to randomization (specified in Protocol section 5.2)
17. Received Ultra-violet A (UVA) phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to randomization, or ultra-violet B (UVB) phototherapy within 2 weeks prior to randomization
18. Received topical psoriasis treatment within 2 weeks prior to randomization (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, face, and intertriginous areas; bland emollients [without urea or α− or β−hydroxy acids])
19. Received live viral or live bacterial vaccination within 2 weeks prior to randomization
20. Received BCG vaccination within 1 year prior to randomization
21. Other investigational procedures within 4 weeks prior to randomization and during the study
General
22. Active substance abuse within 24 weeks prior to randomization
23. For women: pregnant or breast feeding, or planning to become pregnant while participating in the study and for at least 15 weeks after the last dose of investigational product
24. Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) while on study and for 5 months after the last dose of investigational product. Male subjects must agree not to donate sperm during the study and for 5 months following
the treatment with test article or until the scheduled EOS (whichever is longer)
25. Subject likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COA) to the best of the subject and Investigator’s knowledge
26. Any physical or psychiatric disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give informed consent and/or to comply with all required study procedures |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Efficacy Endpoint:
• Psoriasis area severity index (PASI) percent improvement from baseline to week 12 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints:
• PASI percent improvement at other timepoints
• PASI 75 response throughout the study
• PASI 100 response throughout the study
• Static Physician’s Global Assessment (sPGA) responses (0/1) at week 12 and week 52
• Body surface area (BSA) change from baseline at week 12 and week 52
Safety Endpoints:
• TEAEs and SAEs
• EOIs
• Incidence of anti-drug antibodies |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary Efficacy Endpoints:
• at other timepoints
• throughout the study
• throughout the study
• at week 12 and week 52
• week 12 and week 52
Safety Endpoints:
• throughout the study |
|
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
| Immunogenicity, clinical similarity |
|
| 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 | Yes |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 71 |
| 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 |
| Bulgaria |
| Canada |
| Czechia |
| Estonia |
| Germany |
| Hungary |
| Latvia |
| Lithuania |
| Poland |
| Puerto Rico |
| Slovakia |
| Spain |
| United States |
|
| 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 EOS is defined as the date of the last visit of the last subject in the study or last scheduled procedure shown in the SoA (schedule of assessments) for the last subject in the trial globally. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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