A Study to Investigate Interchangeability of ABP 654 for the Treatment of Subjects with Moderate to Severe Plaque Psoriasis

Phase 1

Conditions: Moderate to severe plaque psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2020-005205-42-ES

Lead Sponsor: Amgen, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 352

Inclusion Criteria

1. Subject is male or female and is >/= 18 and 2. Subject has 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. Subject has a baseline score of PASI >/= 12, involvement of >/= 10% body surface area (BSA) and static Physician Global Assessment (sPGA) >/= 3 at screening and at baseline.
4. Subject is a candidate for phototherapy or systemic therapy.
5. Subject has previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy (eg, methotrexate, cyclosporine, psoralen plus ultraviolet light [PUVA]).
6. Female subject (except if at least 2 years postmenopausal or surgically sterile): a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
7. Subject or legally acceptable representative is capable of giving signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) informed consent.
8. Subject has no known history of latent or active tuberculosis. 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 hours to 72 hours after test is placed, or
o Negative Quantiferon®/T-spot® test.
• Subject with a positive PPD test and a history of Bacillus Calmette-Guérin (BCG)
vaccination is allowed with a negative Quantiferon/T-spot test
• Subject with a positive PPD test (without a history of BCG vaccination) or subject with a positive or indeterminate Quantiferon/T-spot test is allowed if he/she has all of the following:
o No symptoms per tuberculosis worksheet provided by the sponsor, Amgen Inc.
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 tuberculosis after most recent prophylaxis
o No evidence of active tuberculosis 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 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 97

Exclusion Criteria

Skin Disease Related Conditions
1. Subject has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis.
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 enrollment
b. Serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to enrollment
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. Subject has known history of human immunodeficiency virus (HIV).
5. Subject has hepatitis B surface antigen or hepatitis C virus antibody positivity at screening.
6. Subject has uncontrolled, clinically significant systemic disease, such as uncontrolled diabetes mellitus, cardiovascular disease, renal disease, liver disease, or hypertension.
7. Subject has known malignancy within the previous 5 years (except treated or considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma).
8. Subject has 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. Subject has moderate to severe heart failure (New York Heart Associate class III/IV).
10. Subject has known hypersensitivity to the investigational product or to any of the excipients.
11. Subject has any concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Laboratory Abnormalities
12. Subject has 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 < 3,000 cells/mm3
d. Aspartate aminotransferase and/or alanine aminotransferase = 2.0 × the upper limit of normal
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. Subject has had previous treatment with any agent specifically targeting IL-12 or IL-23 within 1 year prior to enrollment.
14. Subject has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment.
15. Subject has received any investigational agents within the previous month or 5 half-lives (whichever is longer) prior to enrollment.
16. Subject has received non-biologic systemic psoriasis therapy within 4 weeks prior to enrollment (details in protocol).
17. Subject has received ultraviolet A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or ultraviolet B phototherapy within 2 weeks prior to enrollment.
18. Subject has received topical psoriasis treatment within 2 weeks prior to enrollment (exception: upper mid-strength to least potent [class III to VII] topical steroids permitted on the palms, soles, f

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate pharmacokinetic equivalence in subjects with multiple switches between ustekinumab and ABP 654 compared to subjects receiving continued use of ustekinumab;Secondary Objective: To assess the efficacy, safety and immunogenicity in subjects with multiple switches between ABP 654 and ustekinumab compared with subjects receiving continued use of ustekinumab;Primary end point(s): Pharmacokinetic parameters:<br>• AUCtau between week 52 and week 64<br>• Cmax between week 52 and week 64;Timepoint(s) of evaluation of this end point: between week 52 and week 64

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacokinetic-related Endpoints:<br>• tmax between week 52 and week 64<br>• Ctrough,ss between week 28 and week 52<br>Efficacy-related Endpoints:<br>• PASI percent improvement from baseline (day 1) to week 64<br>• PASI 75 response at week 64<br>• PASI 100 response at week 64<br>Safety-related Endpoints:<br>• Treatment-emergent adverse events and serious adverse events, post randomization<br>• Events of interest, post randomization<br>• Incidence of antidrug antibodies, post randomization;Timepoint(s) of evaluation of this end point: Pharmacokinetic-related Endpoints:<br>• between week 52 and week 64<br>• between week 28 and week 52<br>Efficacy-related Endpoints:<br>• week 64<br>• week 64<br>• week 64<br>Safety-related Endpoints:<br>• post randomization<br>• post randomization<br>• post randomization

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