Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.


Options:
A: Inclusion Criteria:

* Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Current or prior use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
* Current use of more than one conventional DMARD
* Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
B: Inclusion Criteria:

1. Subjects must give a written and signed informed consent.
2. Men or women at least 18 years old at the time of signing the ICF
3. Moderate to severe plaque psoriasis diagnosed at least 6 months before signing the informed consent form.
4. Patients received at least one course of phototherapy or systemic therapy for psoriasis or are candidates for such treatment according to the investigator.
5. Body surface area (BSA) affected by psoriasis of 10% or greater, the PASI score of 10 or greater, and the sPGA score of 3 or greater at screening.
6. Negative pregnancy urine test in female subjects (no test is required in women who are post-menopausal for at least 2 years and in surgically sterile women).
7. The patient must be able to follow the Protocol procedures (in the investigator's opinion).
8. Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent to 20 weeks after the last dose of the study therapy. This requirement does not apply to the patients after surgical sterilization and to females who are post-menopausal for 2 years or longer. Reliable contraception methods suggest using one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives

Exclusion Criteria:

1. Baseline erythrodermic, pustular, and guttate psoriasis or any other skin diseases (e.g. eczema) that can affect/complicate assessment of psoriasis treatment
2. Use of the following medications:

   * Prior use of monoclonal antibodies targeting IL17 or its receptor
   * Prior use of more than one drug containing monoclonal antibodies or their fragments
   * Prior use of monoclonal antibodies within 12 weeks before signing the informed consent.
   * Any systemic medications for psoriasis (including glucocorticoids, methotrexate, sulfasalazine, cyclosporine, acitretin, mycophenolate mofetil, аpremilast, calcitriol derivatives, etc.) used within 4 weeks before signing the ICF If prior systemic therapy with non-biologics was stopped due to any reasons, the screening period can be extended up to 8 weeks during which no new non-biologics are allowed.
   * Use of phototherapy within 4 weeks before signing the ICF
   * Topical medications for psoriasis used within 2 weeks before signing the ICF
   * Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF
3. Any active systemic infection or recurrent infection at screening/randomization
4. HIV, hepatitis B, hepatitis C, or syphilis
5. Blood biochemistry abnormalities appearing as:

   1. baseline creatinine \> 2 × ULN
   2. baseline ALT, AST or alkaline phosphatase \> 2.5 × ULN
   3. baseline bilirubin \> 1.5 × ULN
6. WBC count \< 3.0 × 109/L; ANC \< \<2.0× 109/L; platelet count \< 100 × 109/L, or hemoglobin \< 90 g/L at baseline
7. Any psychiatric conditions including severe depressive disorders and/or any history of suicidal thoughts or suicidal attempts ;
8. Signs of clinically significant depression (Beck's score of 16 or more at screening)
9. Alcohol or substance abuse
10. Tuberculosis now or in the past
11. Latent TB infection (positive results of the Diaskintest or QuantiFERON test, or T-spot).
12. Concurrent diseases ongoing at screening that may increase the risk of adverse events during the study or affect the evaluation of psoriasis symptoms (mask, enhance or alter the symptoms of psoriasis, or cause clinical or laboratory signs/symptoms similar to those of psoriasis):

    * active inflammatory diseases or aggravation of chronic inflammatory diseases other than psoriasis
    * Stable angina class III-IV, unstable angina or a history of myocardial infarction within 1 year before signing the informed consent
    * Cardiac failure moderate to severe (NYHA class III-IV)
    * Treatment-resistant hypertension
    * A history of severe asthma or angioedema
    * Moderate to severe respiratory failure, COPD grade ¾
    * Diabetes mellitus with unsatisfactory glycemic control, when the level of glycated hemoglobin HbA1С ≥8% (results are valid if the test was performed at the screening or within 3 months before signing the ICF)
    * The patient has thyrotoxicosis, which persists in the presence of thyreostatic medications, or hypothyroidism despite of the thyroid hormone treatment
    * Systemic autoimmune diseases (including but not limited to SLE, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease , intersection syndrome, etc.)
    * Any other underlying conditions (including but not limited to metabolic, hematologic, hepatic, renal, pulmonary, neurological, endocrine, cardiac, gastrointestinal conditions and infections) that, in the opinion of the investigator, may affect the course of psoriasis, affect the assessment of signs/symptoms of psoriasis, or put patients using the study treatment at additional risk
13. Malignancies with less than 5 years of remission
14. Known severe allergies (anaphylaxis or drug allergy to two or more drug products)
15. Known allergy or intolerance to monoclonal antibody drugs (murine, chimeric, humanized, or human) or any other components of the test drug or comparator
16. Major surgery within 30 days before the screening, or a major surgery being scheduled at any time during the study
17. Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF
18. Systemic antibacterial/antimycotic/antiprotozoal treatment within 2 months before the signing the ICF
19. More than 4 episodes of respiratory infection within 6 months before signing the ICF
20. Episodes of severe mycoses (histoplasmosis, coccidioidomycosis, blastomycosis, etc.) within 6 months before signing the ICF
21. A history of epileptic attacks or seizures
22. Any concurrent diseases during which, in the investigator's opinion, the study treatment can harm the patient
23. Pregnancy, breastfeeding, or planning for pregnancy while participating in the study
24. Participation in any other clinical study within 3 months before signing the ICF or simultaneous participation in other clinical studies
25. Patients will not be re-enrolled in this study if they were randomized to this study and then discontinue the participation
C: Inclusion Criteria:

* Patients with chronic plaque type psoriasis having body surface area involvement of \> 20%
* Patients of either sex
* Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
* Age range 18-65 years

Exclusion Criteria:

* Females of child bearing potential
* H/O hypersensitivity to acitretin
* Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase \>1.5 times the upper limit of normal)
* Impaired renal function (serum creatinine \>1.5mg% in males and \>1.4 mg% in females)
* Hyperlipidemia
* BMI \>30 kg /m2
* H/O excessive alcohol use
* Diabetes mellitus
* Congestive heart failure
* Ischemic heart disease
D: Inclusion criteria:

* Male or female patients. Women of childbearing potential\* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

  \*Women of childbearing potential are defined as:
  * having experienced menarche and
  * not postmenopausal (12 months with no menses without an alternative medical cause) and
  * not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
* Age ≥ 18 years at screening
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the patient.
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):

  * Have an involved body surface area (BSA) ≥ 10% and
  * Have a Psoriasis Area and Severity Index (PASI) score ≥ 12 and
  * Have a static Physician Global Assessment (sPGA) score of ≥ 3.
* Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
* Must be candidates for treatment with adalimumab (Humira®) according to local label as confirmed by the investigator.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

* Patients with

  * non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
  * current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  * active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
* Previous exposure to ABBV-066
* Previous exposure to adalimumab (Humira®)
* Currently enrolled in another investigational study or less than 30 days or more from screening since completing another investigational drug or device study.
* Use of any restricted medication or any drug considered likely to interfere with the safe conduct of the study.
* Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation).
* Known chronic or relevant acute infections, such as active tuberculosis (TB), human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON® TB test or purified protein derivative (PPD) skin test will be performed according to local labelling for Humira®. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then treatment should have been initiated and maintained according to local country guidelines.
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
* Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram \[ECG\]), or laboratory value at the Screening Visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
* History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Previous enrolment in this trial

Answer: C