Papp 2018.

Study characteristics
Methods	RCT, placebo‐controlled, double‐blind trial, phase 2 Date of study: Novermber 2016 ‐ November 2017 Location: 82 sites In the USA, Japan, Poland, Canada, Germany, Latvia, Mexico, and Australia
Participants	Randomised: 267 participants Inclusion criteria Men and women, ages 18 to 70 years Diagnosis of plaque psoriasis for 6 months Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half‐lives of the study drug plus 90 days. Exclusion criteria Any significant acute or chronic medical illness Blood transfusion within 4 weeks of study drug administration Inability to tolerate oral medication positive hepatitis‐B (HBV) surface antigen Positive hepatitis‐C (HCV) antibody Any history or risk for tuberculosis (TB) Any major illness/condition or evidence of an unstable clinical condition Chest X‐ray findings suspicious of infection at screening Has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication Has received anti‐Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication Has received Rituximab within 6 months of first administration of study medication. Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication Other protocol‐defined inclusion/exclusion criteria could apply Dropouts and withdrawals 61/267 (15.%): BMS‐986165_3EOD (10), BMS‐986165_3 (8), BMS‐986165_3*2 (3), BMS‐986165_6*2 (6), BMS‐986165_12 (2), PBO (14) Lost to follow‐up: BMS‐986165_3EOD (0), BMS‐986165_3 (1), BMS‐986165_3*2 (1), BMS‐986165_6*2 (2), BMS‐986165_12 (0), PBO (1) AEs: BMS‐986165_3EOD (1), BMS‐986165_3 (2), BMS‐986165_3*2 (1), BMS‐986165_6*2 (3), BMS‐986165_12 (1), PBO (2) Lack of efficacy: BMS‐986165_3EOD (4), BMS‐986165_3 (3), BMS‐986165_3*2 (0), BMS‐986165_6*2 (0), BMS‐986165_12 (1), PBO (5) Participant: BMS‐986165_3EOD (5), BMS‐986165_3 (0), BMS‐986165_3*2 (1), BMS‐986165_6*2 (1), BMS‐986165_12 (0), PBO (5) Others: BMS‐986165_3EOD (0), BMS‐986165_3 (2), BMS‐986165_3*2 (0), BMS‐986165_6*2 (0), BMS‐986165_12 (0), PBO (1)
Interventions	Intervention: A. BMS‐986165 3 mg every other day (EOD) (by mouth), n = 44 Control intervention: B. BMS‐986165 3 mg a day (by mouth), n = 44 C. BMS‐986165 3 mg*2 a day (by mouth), n = 45 D. BMS‐986165 6 mg*2 a day (by mouth), n = 45 E. BMS‐986165 12 mg a day (by mouth), n = 44 F Placebo, n = 45
Outcomes	At week 12 Primary outcome: PASI 75 Secondary outcomes: IGA 0/1 PASI 50, 90, 100 DLQI 0/1 AEs
Notes	Funding Quote (p 1320): "Supported by Bristol‐Myers Squibb." Conflicts of interest Quote (p 1320‐21): "Dr. Papp reports receiving grant support, consulting fees, advisory board fees, and fees for serving on a speakers’ bureau from Amgen, AbbVie, Boehringer Ingelheim, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, UCB, Valeant Pharmaceuticals, and Kyowa Hakko Kirin, grant support, consulting fees, and fees for serving as a scientific officer from Akros Pharma, consulting fees from Can‐Fite BioPharma, grant support, consulting fees, advisory board fees, fees for serving on a speakers’ bureau, and travel support from Celgene, grant support, consulting fees, and advisory board fees from Merck Sharp & Dohme, PRCL Research, and Takeda, grant support from Anacor Pharmaceuticals, GlaxoSmithKline, and Meiji Seika Pharma, and grant support and consulting fees from Coherus BioSciences and Dermira; Dr. Gordon, receiving grant support and consulting fees from AbbVie, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, and UCB and consulting fees from Amgen, Almirall, Dermira, Leo Pharma, Pfizer, and Sun Pharma; Dr. Thaçi, receiving grant support, lecture fees, consulting fees, and advisory board fees from AbbVie, lecture fees, consulting fees, and advisory board fees from Almirall, Pfizer, Sandoz/Hexal, UCB, Regeneron Pharmaceuticals, and Sanofi, consulting fees and advisory board fees from Boehringer Ingelheim, grant support, lecture fees, consulting fees, advisory board fees, and writing assistance from Celgene and Novartis, and lecture fees, consulting fees, advisory board fees, and writing assistance from Eli Lilly, Leo Pharma, and Janssen‐Cilag; Dr. Morita, receiving grant support and lecture fees from AbbVie, Esai, Kyowa Hakko Kirin, Leo Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, and Torii Pharmaceutical and lecture fees from Celgene, Eli Lilly Japan, and Janssen Pharmaceutical; Dr. Gooderham, receiving advisory board fees, fees for serving as principal investigator, and lecture fees from AbbVie, Galderma, Leo Pharma, Pfizer, and Regeneron Pharmaceuticals, advisory board fees and lecture fees from Actelion Pharmaceuticals, fees for serving as principal investigator and consulting fees from Akros Pharma, advisory board fees, fees for serving as principal investigator, lecture fees, and consulting fees from Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis Pharmaceuticals, Sanofi Genzyme, and Valeant Pharmaceuticals, fees for serving as principal investigator from Arcutis Pharmaceuticals, Bristol‐Myers Squibb, Dermira, GlaxoSmithKline, MedImmune, Merck, Roche Laboratories, and UCB, and fees for serving as principal investigator and lecture fees from Glenmark; Dr. Foley, receiving grant support, advisory board fees, fees for serving on a speakers’ bureau, and travel support from AbbVie, Celgene, CSL, Galderma, iNova Pharmaceuticals, Janssen, Leo Pharma, Eli Lilly, Novartis, Pfizer, and Sanofi, grant support and advisory board fees from Amgen and Sun Pharma, grant support from Boehringer Ingelheim, Celtaxsys, Cutanea Life Sciences, Dermira, Genentech, and Regeneron Pharmaceuticals, grant support, advisory board fees, and fees for serving on a speakers’ bureau from GlaxoSmithKline, grant support and consulting fees from Bristol‐Myers Squibb, and grant support, fees for serving on a speakers’ bureau, and travel support from Roche; Dr. Kundu, being employed by Bristol‐Myers Squibb; and Dr. Banerjee, being employed by and holding stock in Bristol‐Myers Squibb. No other potential conflict of interest relevant to this article was reported."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (p 1314):"Randomization was stratified according to previous treatment with a biologic agent (yes or no) and geographic region (Japan or the rest of the world), with the use of a central interactive Web‐response system." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (p 1314):"Randomization was stratified according to previous treatment with a biologic agent (yes or no) and geographic region (Japan or the rest of the world), with the use of a central interactive Web‐response system." Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (p 1314): "Patients were randomly assigned to one of five oral doses of BMS‐986165 (3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, or 12 mg daily) or matching oral placebo in a ratio of 1:1:1:1:1:1. Capsules of the active drug (3 mg) or matched placebo were combined as appropriate to provide the required daily dose and were taken each morning and again 12 hours later...Patients, investigators, and the trial sponsor were unaware of the trial‐group assignments." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (p 1314): "Patients were randomly assigned to one of five oral doses of BMS‐986165 (3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, or 12 mg daily) or matching oral placebo in a ratio of 1:1:1:1:1:1. Capsules of the active drug (3 mg) or matched placebo were combined as appropriate to provide the required daily dose and were taken each morning and again 12 hours later...Patients, investigators, and the trial sponsor were unaware of the trial‐group assignments.'' Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dealing with missing data Quote (p 1315): "For the primary end point of PASI 75 and other binary end points (PASI 50, PASI 90, PASI 100, an sPGA score of 0 or 1, and a DLQI score of 0 or 1), patients who discontinued the trial regimen early or who had a missing value at any time point had outcomes imputed as a nonresponse at that time point, regardless of the status of response at the time of discontinuation." Randomised 267, analysed 267 Comment: Done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02931838) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported