A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

Phase 3

Completed

• Conditions: Plaque Psoriasis; Psoriasis; 10003816

• Registration Number: NL-OMON41423
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first ose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).;Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling.;Subject has involved body surface area (BSA) >= 10%, PASI >= 12, and sPGA >= 3 at screening and at baseline.;Subject has no known history of active tuberculosis.;Subject has a negative test for tuberculosis during screening

Exclusion Criteria

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis.;Subject has a planned surgical intervention between baseline and the week 52 evaluation.;Subject has an active infection or history of infections;Subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled.;Subject has known history of Crohn*s disease.;Subject has laboratory abnormalities at screening, including any of the following:
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x the upper limit of normal
• serum direct bilirubin >= 1.5 mg/dL
• white blood cell (WBC) count < 3.00 x 103/µL
• ANC < 2.00 x 103/µL
• 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.;Subject has used topical therapy as follows:
• Super-potent or potent topical steroids or topical anthralin/dithranol within 28 days before first dose of IP
• Any other formulation or potency of topical therapy within 14 days before first dose of IP (exception: upper mid-strength or lower potency topical steroids permitted on the face, axillae, and groin; bland emollients [without alpha or beta hydroxy acids]; shampoo without steroids).;Subject has used the following within 28 days of first dose of IP:
ultraviolet A light therapy (with or without psoralen); ultraviolet B light therapy; excimer laser; oral retinoids; methotrexate; cyclosporine; systemically administered calcineurin inhibitors; zathioprine; thioguanine; hydroxyurea; fumarates; or oral or parenteral corticosteroids including intramuscular or intraarticular administration (exception: otic, nasal, ophthalmic, or inhaled corticosteroids within recommended doses is permitted); other non-biologic systemic therapy for psoriasis.;Subject has received live vaccine(s) within 28 days of the first dose of IP (or longer, according to local requirements for ustekinumab [eg, 1 year in the United States for BCG vaccination]).;Subject has used ustekinumab and/or anti-IL-17 biologic therapy ever or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.;Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).;For women (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by FSH in the postmenopausal range): not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose (if discontinuing before week 52) or for 8 weeks after the last dose (if discontinuing at or after week 52).;For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose (if discontinuing before week 52) or for 8 weeks after the last dose (if discontinuing at or after week 52).

Study & Design

• Study Type: Interventional
• Study Design: Not specified