Please select the eligibility criteria that correspond to the clinical trial below.
Title: BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
Brief Summary: This is a randomized double blind, double dummy, active comparator controlled, parallel design study that is performed to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) compared to adalimumab to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.


Options:
A: Inclusion Criteria Common to Both Part A:

* Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.
* Participant is a candidate for systemic therapy
* Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization

Inclusion Criterion Specific to Part B

* Participant has completed the treatment period for part A (at least through week 20)

Inclusion Criterion Specific to Part C

* Participant has completed the treatment period for part B

Exclusion Criteria Common to Part A, B and C:

* Participant has pustular, erythrodermic and/or guttate forms of psoriasis
* Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry
* Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \>28 days, infliximab or adalimumab \>56 days, alefacept \>60 days, ustekinumab \>8 months, or any other biologic agent/monoclonal antibody \>5 half-lives prior to baseline
* Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \[PUVA\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 \[mild, such as desonide\] or 7 \[least potent, such as hydrocortisone\] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)
* Participant has donated more than 500 mL of blood within the last month
* Participant has another serious disorder or illness
* Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months
* Participant has a history of uncontrolled high blood pressure
* Participant has clinical laboratory test results at entry that are outside the normal reference range
* Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
* Participant is a woman who is lactating or breast feeding
* If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study
* If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months
* If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate
* If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study

Exclusion Criteria Specific to B:

* If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab
* If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

Exclusion Criteria Specific to C:

* If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab
* If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant.
B: 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
C: Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to the first screening procedure.
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed.
* Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
* Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.
D: Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
* Subject has any active CTCAE grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
* Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
* Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
* Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
* Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab

Answer: B