Skip to main content
. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

CLEAR 2015.

Study characteristics
Methods (applé THACI clear ds cochrane)RCT, active‐controlled, double‐blind
Date of study: 27 February 2014 – 11 May 2015
Location: 137 centres in Europe, Australia and Asia
Participants Randomised: 676 participants (mean age 46 years, 481 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI ≥ 12, BSA ≥ 10), age ≥ 18 years


Exclusion criteria
  • Immunosuppression, active infection

  • Had received anti IL17 drug or ustekinumab


Dropouts and withdrawals
  • 32/676 (4.7%)

  • Did not receive the treatment (4)

  • Information consent obtained the day after study‐related procedure (1, excluded from the efficacy analysis)

  • AE (7)

  • Lost to follow‐up (3)

  • Protocol deviation (5)

  • Participant/guardian decision (7)

  • Physician decision (1)

  • Non‐compliance with study treatment (1)

  • Technical problem (1)

Interventions Intervention
A. Secukinumab (n = 334), SC, 300 mg weeks 0, 1, 2, 3 then monthly
Control intervention
B. Ustekinumab (n = 335), SC, 45/90 mg weeks 0, 4 then every 12 weeks
Outcomes Assessments at 16 weeks
Primary outcomes of the trial
  • PASI 90


Secondary outcomes of the trial
  • PASI 75

  • PASI 90 at week 54

  • DLQI

  • AEs

Notes Funding source:
Quote (p 400): "Novartis Pharma supported this study"
Declarations of interest (p 400): "Dr Thaçi has served as a consultant, served as an advisory board member, and/or received honoraria for lecturing for AbbVie, Amgen, Biogen‐Idec, Celgene, Eli Lilly, Janssen‐Cilag, Leo Pharma, MSD, Novartis, Pfizer, Regeneron, and Sanofi. Dr Blauvelt has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Ortho Biotech, Merck, Novartis, Pfizer, and Sandoz. Dr Reich has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Amgen, Biogen‐Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen‐Cilag, Leo Pharma, Medac, MSD, Novartis, Pfizer, Vertex, Takeda, and Xenoport..."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 402): “were randomised via an interactive response technology system" Randomization was conducted via Interactive Response Technology, which assigned a randomisation number that linked the subject to a treatment arm and specified unique medication pack number
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p 402): “were randomised via an interactive response technology system “
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 402) : “To maintain blinding, placebo injections matching the secukinumab regimen were given in the ustekinumab group”
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 402) : “To maintain blinding, placebo injections matching the secukinumab regimen were given in the ustekinumab group”
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk Randomly assigned 676, analysed 669
Management of missing data:
Quote (p 403): “Missing values with respect to response variables based on PASI and IGA mod 2011 scores were imputed as nonresponse (nonresponder imputation)."
Comment: It was not an ITT analysis as 7 participants were not taken into account, but low rate of dropout
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02074982)
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported