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

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)

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.

This study consists of 2 parts (Part A and Part B).

Part A:

• Participants were randomized to receive either risankizumab or adalimumab.

Part B:

• Participants who received risankizumab in Part A continued to receive risankizumab in Part B
• Adalimumab nonresponders (<PASI 50 at Week 16) switched to risankizumab in Part B;
• Adalimumab responders (PASI 90 at Week 16) continued to received adalimumab in Part B;
• Adalimumab inadequate responders (PASI 50 to <PASI 90) were rerandomized to receive either risankizumab or adalimumab in Part 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