Bmab 1200 versus Stelara® in Patients with Moderate to Severe Chronic Plaque Psoriasis
- Conditions
- Moderate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-006668-25-LV
- Lead Sponsor
- Biocon Biologics UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 384
1. 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;
2. Patient is aged 18 to 80 years, both inclusive, and weighing <130 kg at the time of the screening visit;
3. 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;
4. Patient with moderate to severe chronic plaque psoriasis as defined by BSA involvement =10%, PASI score =12, and sPGA =3 at the screening and baseline visits;
5. Patient has stable disease for at least 2 months before the baseline visit;
6. Patient has adequate renal and hepatic function at the screening
7. Patient has the following hematology laboratory test results at screening:
a) Hemoglobin =10.0 g/dL;
b) Absolute neutrophil count =1500/µL (SI units: =1.5 × 10^9 cells/L);
c) Platelet count =100 000/µL (SI units: =100 × 10^9 cells/L);
8. Patient has had a previous failure, inadequate response, intolerance, or contraindication to at least one antipsoriatic systemic therapy;
9. 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 (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy);
10. Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions which are consistent with local regulations regarding the use of birth control methods for patients participating in clinical studies throughout the study period and continuing for at least 15 weeks after the last dose of study drug. Please refer to APPENDIX 1 of protocol for acceptable highly effective contraceptive methods. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 15 weeks after the last dose of study drug.
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 344
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. 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 of psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate;
2. Patient who has a current or past history of any of the following infections:
a) 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;
b) Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening;
c) 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;
d) 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;
e) History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.
3. Patient meeting any of the following tuberculosis (TB)-related conditions:
a) Patient who has current or history of active TB.
b) Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening.
c) Patients with current latent TB d) Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit.
4. Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
5. Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
6. Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.
7. Patient who has received or plans to receive any of the following prohibited medications or treatment that could affect psoriasis:
a) Topical therapies for the treatment of psoriasis within 2 weeks before the baseline visit.
b) Ultraviolet A phototherapy (with or without oral psoralen) or ultraviolet B phototherapy for the treatment of psoriasis within 4 weeks before the baseline visit.
c) Systemic steroids within 4 weeks before the baseline visit.
d) Any nonbiologic systemic therapies for the treatment of psoriasis or psoriatic arthritis within 4 weeks before the baseline visit.
e) Any biologic systemic therapy with a mechanism of action that could impact the course of psoriasis/psoriatic arthritis or its evaluations, within 5 half-lives or 90 days, whichever is longer, before the baseline visit.
f) Any
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate equivalent efficacy between Bmab 1200 and Stelara® in patients with moderate to severe chronic plaque psoriasis.;Secondary Objective: - To assess the efficacy of Bmab 1200 based on other efficacy parameters and timepoints over the study period as compared with Stelara®;<br><br>- To assess the safety and tolerability of Bmab 1200 as compared with Stelara® over the study period;<br><br>- To assess the immunogenicity of Bmab 1200 as compared with Stelara® over the study period;<br><br>- To assess the PK of Bmab 1200 as compared with Stelara®;<br><br>- To assess the safety and immunogenicity after switching from Stelara® to Bmab 1200;<br>;Primary end point(s): Percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score at Week 12 (Time Frame: Baseline [Day 1] to Week 12).;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method