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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

NCT03535194.

Study name A study to assess if mirikizumab is effective and safe compared to secukinumab and placebo in moderate‐to‐severe plaque psoriasis (OASIS‐2)
Methods RCT, active/placebo‐controlled, double‐blind study
Date of study: May 2018
Location: world‐wide
Phase 3
Participants Randomised: 1484 participants
Inclusion criteria
  • Participant must have chronic plaque psoriasis for at least 6 months


Exclusion criteria
  • Not be breastfeeding or nursing woman

  • Must not have had serious, opportunistic, or chronic/recurring infection within 3 months

  • Must not have received a Bacillus Calmette‐Guerin (BCG) vaccination within 12 months or received live vaccine(s) (including attenuated live vaccines) within 12 weeks of baseline or intend to receive either during the study

  • Must not have any other skin conditions (excluding psoriasis)

  • Must not have previous exposure to Cosentyx and any other biologic therapy targeting IL‐17 (including Taltz)

  • Must not have received anti‐tumour necrosis factor (TNF) biologics within 8 weeks

  • Must not have previous exposure to any biologic therapy targeting IL‐23 (including Stelara)

Interventions Intervention
A. Mirikizumab
Control interventions
B. Secukinumab
C. Placebo
Outcomes At week 16
Primary composite outcome
PASI 90 ‐ IGA 0/1
Secondary outcome
PASI 75
DLQI
SF‐36
Change from baseline in quick inventory of depressive symptomology
Starting date Study start date: May 2018
Actual study completion date: May 2020
Last update posted: August 2020, active, recruiting
Contact information Study Director: call 1‐877‐CTLILLY (1‐877‐285‐4559)
Notes Sponsor: Eli Lilly and Company
Ongoing study
Last checked in September 2020