A Study to Investigate ABP 654 for the Treatment of Subjects with Moderate to Severe Plaque Psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-003184-25-BG
- Lead Sponsor
- Amgen, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 542
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-Guerin (BCG) vaccination are allowed with a negative Quantiferon®/T-spot®
• Subjects with a positive PPD test (without a history of 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
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 435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107
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
d. Active COVID-19 infection as confirmed by a SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test at screening
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,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of ABP 654 with ustekinumab in subjects with moderate to severe plaque psoriasis.;Secondary Objective: To assess the safety and immunogenicity of ABP 654 compared with ustekinumab.;Primary end point(s): Primary Efficacy Endpoint:<br>• Psoriasis area severity index (PASI) percent improvement from baseline to week 12;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Endpoints:<br>• PASI percent improvement at other timepoints<br>• PASI 75 response throughout the study<br>• PASI 100 response throughout the study<br>• Static Physician’s Global Assessment (sPGA) responses (0/1) at week 12 and week 52<br>• Body surface area (BSA) change from baseline at week 12 and week 52<br>Safety Endpoints:<br>• TEAEs and SAEs<br>• EOIs<br>• Incidence of anti-drug antibodies;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoints:<br>• at other timepoints<br>• throughout the study<br>• throughout the study<br>• at week 12 and week 52<br>• week 12 and week 52<br>Safety Endpoints:<br>• throughout the study