Study to Evaluate Broadlumab vs Placebo and Ustekinumab (AMAGINE-3)

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis Read More

Inclusion Criteria:

• Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP.
• Subject has involved body surface area >_10%, PASI>_, and sPGA>_3 at screening and at baseline.
• For women, a negative serum pregnancy test during screening a negative urine pregnancy test 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 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 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 known history of hepatitis B, hepatitis C, or human immunodeficiency virus.
• Subject had myocardial infarction or unstable angina pectoris within the past 12 months prior to the first dose of IP.
• Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
• Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
• Subject has received live vaccine(s) within 28 days of the first dose of IP.
• Subject has used ustekinumab and/or antio-IL-17 biologic therapy ever or other experimental or commercially available biologi immune modulator(s) within 12weeks 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 not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose.
• For women; pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose.