NCT03255382.

Study characteristics
Methods	RCT, active‐controlled, open‐label study with blinded assessment of the efficacy outcome Date of study: August 2017 ‐ July 2018 Location: Germany (23 sites) Phase 3
Participants	Randomised: 120 participants Inclusion criteria Have a diagnosis of chronic plaque psoriasis for at least 6 months before the first administration of study drug. Duration since diagnosis may be reported by the participant Participant has stable moderate‐to‐severe plaque psoriasis (body surface area [BSA] > 10, Psoriasis Area and Severity Index [PASI] > 10, and Dermatology Quality of Life Index [DLQI] > 10) with or without psoriatic arthritis at Baseline Must be naïve to and candidate for systemic therapy, as assessed by the investigator Participant has an inadequate response, intolerance or contraindication to topical psoriasis treatment Exclusion criteria Patients with non‐plaque forms of psoriasis Patient has previously received systemic therapy for psoriasis, whether biologic or non‐biologic or photochemotherapy Active systemic infection during the last 2 weeks (exception: common cold) prior to screening Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately‐treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix Patient has any condition or contraindication to Fumaderm that would preclude their participation in the present study Baseline characteristics N = 120, mean age of 42 years and 59% men Dropouts and withdrawals 13/120 (11%): Risankizumab group (0), Fumaderm 300 group (13) AEs: Risankizumab group (0), Fumaderm 300 group (3) Lost to follow‐up: Risankizumab group (0), Fumaderm 300 group (2) Withdrawal by Subject: Risankizumab group (0), Fumaderm 300 group (2) Other: Risankizumab group (0), Fumaderm 300 group (6)
Interventions	Intervention A. Risankizumab 150 mg by subcutaneous injection at weeks 0, 4, and 16, n = 60 Control intervention B. Fumaderm 30 mg administered as a tablet orally once daily from week 0 to Week 2, then up to 240 mg, n = 60
Outcomes	At week 24 Primary outcome PASI 90 Secondary outcomes PASI 50, PASI 75, PASI 100(at weeks 4, 8, 12, 16, 20 and 24) BSA (at weeks 4, 8, 12, 16, 20 and 24) SF‐36, EQ‐5D‐5L (at weeks 16 and 24) PGA (at weeks 4, 8, 12, 16, 20 and 24) PSS (at weeks 16 and 24) Psoriasis Scalp Severity Index (PSSI) (at weeks 16 and 24) Patient Benefit index (at weeks 16 and 24) Clinical Severity of Nail Psoriasis (NAPPA‐CLIN) (at weeks 16 and 24) Palmoplantar Psoriasis Severity Index (PPASI) (at weeks 16 and 24) DLQI (at weeks 16 and 24) Nail Psoriasis Severity Index (NAPSI) (at weeks 16 and 24)
Notes	Funding: Quote (ClinicalTrials.gov) AbbVie Conflict of interest: not stated RoB completed according to ClinicalTrials.gov protocol
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (study protocol p 59):"All subjects will be centrally randomized using an Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS). Before the study is initiated, the telephone number/call‐in directions and web based information for the IVRS/IWRS will be provided to each site.'' Comment: adequate process
Allocation concealment (selection bias)	Low risk	Quote (study protocol p 59):"All subjects will be centrally randomized using an Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS). Before the study is initiated, the telephone number/call‐in directions and web based information for the IVRS/IWRS will be provided to each site.'' Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote (study protocol p 60):"This is an open‐label study; however, the efficacy assessor will be blinded to the patient's study treatment."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote (study protocol p 60):"This is an open‐label study; however, the efficacy assessor will be blinded to the patient's study treatment." Comment: no description of method used to guarantee no communication between participants and assessors.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dealing with missing data: Quote (ClinicalTrials.gov and study protocol p7):"The efficacy analysis will be performed in the Intent to Treat (ITT) set which includes all subjects who are randomized. Missing data will be imputed using non‐responder imputation, i.e., a subject with missing PASI90 at Week 24 will be considered a non‐responder in the primary analysis... For categorical secondary endpoints, the same statistical test as for the primary endpoint will be used, missing data will be imputed using non‐responder imputation." Randomly assigned 120, analysed 120 Comment: probably done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT03255382) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported Results are posted on ClinicalTrials.gov