BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

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, HIV or viral
hepatitis; QuantiFERON® TB test or 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 tuberculosis. If presence of
latent tuberculosis 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 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