| Study characteristics |
| Methods |
RCT, active/placebo‐controlled, double‐blind trial
Date of study: February 2016 ‐ August 2017
Location: worldwide
Phase 3 |
| Participants |
Randomised: 605 participants planned
Inclusion criteria
Men and women. 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 < 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information Age ≥ 18 years at screening Diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for ≥ 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant Stable moderate‐severe chronic plaque psoriasis with or without psoriatic arthritis at both screening and baseline (randomisation) BSA ≥ 10% PASI score ≥ 12 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
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 BI 655066 Previous exposure to adalimumab (Humira®). Major surgery performed within 12 weeks prior to randomisation or planned within 12 months after screening (e.g. hip replacement, removal aneurysm, stomach ligation) Known chronic or relevant acute infections, such as active TB, HIV or viral hepatitis; confirmation of these diseases testing is required at screening. 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 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 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
Dropouts and withdrawals
20/605 (3.3%); risankizumab group (7), adalimumab group (13) AEs: risankizumab group (3), adalimumab group (7) Protocol violation: risankizumab group (0), adalimumab group (1) Withdrawal: risankizumab group (1), adalimumab group (3) Lost to follow‐up: risankizumab group (2), adalimumab group (1) Other reason: risankizumab group (1), adalimumab group (1)
|
| Interventions |
Intervention
Risankizumab: 150 mg (2 syringes of 75 mg) at Weeks 0, 4 and every 12 weeks, n = 301
Control intervention
Adalimumab: 80 mg at randomisation; then 40 mg at Weeks 1, 3, 5 and every other week, n = 304 |
| Outcomes |
At week 16
Primary outcome
Secondary outcomes
|
| Notes |
Funding: Abbvie, Boehringer Ingelheim
Conflict of interest; not stated |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote (Protocol): "Active‐controlled, double‐blind, double dummy, randomized, parallel design comparison of BI 655066 and adalimumab over 44 weeks... An IRT will be used to allocate medication to patients through medication numbers. At randomization as well as subsequent medication dispense visit, IRT will assign medication numbers"
Comment: Probably done |
| Allocation concealment (selection bias) |
Low risk |
Quote (Protocol): "Active‐controlled, double‐blind, double dummy, randomized, parallel design comparison of BI 655066 and adalimumab over 44 weeks... An IRT will be used to allocate medication to patients through medication numbers. At randomization as well as subsequent medication dispense visit, IRT will assign medication numbers"
Comment: Probably done |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote (Protocol and statistical plan): "Active‐controlled, double‐blind, double dummy, randomized, parallel design comparison of BI 655066 and adalimumab over 44 weeks...Subjects will be blinded to treatment. Subjects in each dose group will receive the same injections at each designated time point, in order to maintain blinding."
Comment: Probably done |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote (Protocol and statistical plan): "Active‐controlled, double‐blind, double dummy, randomized, parallel design comparison of BI 655066 and adalimumab over 44 weeks...Subjects will be blinded to treatment. Subjects in each dose group will receive the same injections at each designated time point, in order to maintain blinding."
Comment: Probably done |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Dealing with missing data:
Quote (Protocol and statistical plan): "Efficacy variables will be summarized in all ITT populations... The NRI will be the primary approach in the analyses of categorical variables"
Results posted on ClinicalTrials.gov: ITT results |
| Selective reporting (reporting bias) |
Low risk |
Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02694523)
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported |
