Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).


Options:
A: Inclusion Criteria:

* Has a disease duration of plaque psoriasis of either less than or equal to (\<=2) years or (greater than (\>2) years calculated from date at which first symptoms \[plaque\] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration \<=2 years
* Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>10 or affected body surface area (BSA) \>10%) and additionally a Dermatology Life Quality Index (DLQI) score \>10 at baseline (week 0)
* Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
* Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
* Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

Exclusion Criteria:

* Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab \[MK3222\], risankizumab \[BI-655066\])
* Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug.
* Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
* Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
* Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
B: Inclusion Criteria:

Double-blind Treatment Period

* Male or female at least 18 years of age
* Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
* Subject must have Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5 point scale
* Subject must be a candidate for systemic PSO therapy and/or phototherapy
* Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
* Female subject of childbearing potential must be willing to use highly effective method of contraception

Open-label extension (OLE) Period

* Completed the double-blind Treatment Period without meeting any withdrawal criteria
* All Week 48 visit assessments completed
* Compliant with ongoing clinical study requirements
* Signed a separate OLE Period Informed Consent Form (ICF)
* Female subject of childbearing potential must be willing to use highly effective method of contraception

OLE2 Period (USA and Canada)

* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF

Exclusion Criteria:

Double-blind Treatment Period

* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or severe depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

OLE2 Period (USA and Canada)

* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
C: Inclusion Criteria:

* Plaque-type psoriasis diagnosed \>= 6 months prior
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of \>=12 at screening and baseline
* Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
* Women of childbearing potential and all men must agree to use adequate birth control measures throughout the trials and for 12 months following the last injection of study agent
* Have no history of latent or active tuberculosis (TB)

Exclusion Criteria:

* Currently have nonplaque forms of psoriasis or drug-induced psoriasis
* Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
* Patients who have used any therapeutic agent targeted at reducing IL-12 or IL-23
* Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
* Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months prior to screening
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
* Patients participating in another trial using an investigational agent or procedure
* Systemic immunosuppressants within 4 weeks of the first administration of study agent
D: Inclusion Criteria:

1. Able and willing to give written informed consent.
2. Men or women is ≥18 and ≤ 75 years of age at time of screening.
3. Stable moderate to severe plaque psoriasis for at least 6 months before Screening.
4. Moderate to severe psoriasis as defined at Baseline by:

   BSA of ≥ 10% involvement at the Baseline visit. PGA score of ≥ 3 at the Baseline visit. PASI score of ≥ 12 at the Baseline visit.
5. Acceptable to systemic therapy, as judged by the investigator.
6. Previously received at least one traditional psoriasis treatment (for example, methotrexate, cyclosporine A, psoralen plus UVA or UVB, tretinoin, Chinese medicine, etc.), and was insensitive, intolerant, contraindicated to, or failed the treatment, as judged by the investigator.
7. At time of screening, lab tests have to meet the following:

   1. Hemoglobin ≥ 90 g/L
   2. WBC ≥ 3.5 × 10\^9/L
   3. Platelets ≥ 100 × 10\^9/L
   4. Serum creatinine ≤1.5 × upper limit of normal (ULN)
   5. AST and ALT ≤2 × ULN
8. For women of child-bearing age, a negative serum pregnancy test during screening, and a negative urine pregnancy test at baseline.
9. During the study to 150 days after the last dose of study medicine, subjects should use effective contraceptive measures
10. Subject is willing and able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

1. At screening visit, subjects with erythrodermic psoriasis, pustule psoriasis, bit type psoriasis, drug-induced psoriasis, other skin lesions (such as eczema), other systemic autoimmune inflammatory lesions, which may affect the efficacy evaluation of the treatment.
2. The subject has surgery plan during the study period (excluding surgery that is related to the study disease), except that there will be no increased risk for the subjects or no influence on the study treatment or adherence to the study as judged by the investigator.
3. Participants were given the following treatment, or will be required to receive the following treatment during the study period:

   1. The use of topical drugs within the first two weeks before screening;
   2. The use of UVA and/or UVB treatment, and non-biological drugs (such as methotrexate, cyclosporin, tretinoin, traditional Chinese medicine, proprietary Chinese medicine, etc) within the first four weeks before screening;
   3. In the first 4 weeks before screening, the use of Etanercept or Etanercept; in the first 12 weeks before screening, the use of other biological agents
4. Subjects had live vaccination in the first four weeks before screening, or have the intention to receive live vaccination during the study period.
5. Subjects with history of mycobacterium tuberculosis infection, or with active tuberculosis, or with latent tuberculosis, or with suspected tuberculosis infection judged by clinical phenotypes.
6. Anti-HIV antibody positive, or antibody positive for treponema pallidum, or anti-HCV antibody positive, or HBV HBsAg and/or HBcAb positive at screening.
7. Accompanying active infection or history:

   1. Within 4 weeks before screening, systemic anti-infection treatment;
   2. Within 8 weeks before screening, severe infection with hospitalization or intravenous anti-infection treatment;
   3. Recurrent, chronic, or other active infections, which may increase the study risk as evaluated by the investigator.
8. Known malignancy or history of malignancy (except for the following: in situ skin squamous carcinoma after thorough treatment with no sign of recurrence, basal cell carcinoma, cervical cancer in situ, or skin squamous carcinoma at least five years prior to randomization with no signs of recurrence after treatment).
9. Ongoing, severe, progressive, or uncontrolled diseases, including but not limited to diseases at the endocrine system, blood system, urinary system, liver and gallbladder, respiratory system, nervous system, cardiovascular system, gastrointestinal system or infectious diseases, with increased risk to participate the study as assessed by the investigator.
10. The subjects with active neuropathies, such as multiple sclerosis, Guillain-Barre Syndrome, optic neuritis, transverse myelitis, or neurological symptoms suggestive of the demyelinating diseases of the central nervous system.
11. Moderate to severe heart failure (NYHA III/IV)
12. History of allergic reactions to the active components of the study drugs (HLX03 and adalimumab (Humira®)) and their formulation gradients, or medicines belonging to the same pharmacology and biological category.
13. Participated in another study and received an experimental related drugs within the previous 3 months before screening.
14. Pregnant or lactating women.
15. History of alcohol or substance abuse or dependence, mental disorders.
16. Any condition that will lead to no treatment benefit or affect efficacy evaluation, as judged by the investigator.

Answer: B