Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chroni… (NCT05335356) | Clinical Trial Compass
CompletedPhase 3
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
United States384 participantsStarted 2022-06-28
Plain-language summary
This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion.
✓. Patient is aged 18 to 80 years, both inclusive, and weighing \<130 kg at the time of the screening visit.
✓. Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate for systemic therapy or phototherapy at the time of the screening visit.
✓. Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement
✓. Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
✓. Patient has adequate renal and hepatic function at the screening
✓. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. A female patient is considered not of childbearing potential when postmenopausal or surgically sterilized
✓. Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.
Exclusion criteria
✕. Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment on psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate.
✕. Patient who has a current or past history of any of the following infections:
✕. Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening.
✕. Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening.
✕. Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization ≤8 weeks before baseline visit, or oral/intramuscular antibiotics ≤4 weeks before baseline visit, or topical antibiotics ≤2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed.
✕. Any recurrent bacterial, fungal, opportunistic or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study.
✕. History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.
✕. Patient meeting any of the following tuberculosis (TB)-related conditions: