Khatri 2016

Methods	Randomised, double‐blind, active‐controlled trial Date: April 2015‐August 2016 Location: USA
Participants	Total sample size: 12 Inclusion criteria Present with chronic moderate‐severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for ≥ 6 months prior to baseline Active psoriatic skin lesions of plaque psoriasis (Ps) Are a candidate for phototherapy and/or systemic therapy Men must agree to use a reliable method of birth control or remain abstinent during the study and for ≥ 12 weeks after stopping treatment Women must agree to use reliable birth control or remain abstinent during the study and for ≥ 12 weeks after stopping treatment Exclusion criteria Are unable to commit to the photography schedule for the duration of the study Have participated in any study with interleukin 17 (IL‐17) or (IL‐23) antagonists, including ixekizumab Serious disorder or illness other than psoriasis Serious infection within the last 3 months Breastfeeding or nursing (lactating) women
Interventions	Intervention: Ixekizumab once every 2 weeks, SC, 160 mg 2 injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44 Control intervention: Ixekizumab once every 4 weeks, SC, 160 mg, 2 injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once every 4 weeks through week 44
Outcomes	At week 12, Primary outcome Patient's Global Assessment of Disease Severity Secondary outcomes Itch Numeric Rating Scale DLQI PASI BSA AEs
Notes	NCT02387801 Study start date: April 2015 Study completion date: August 2016 Published abstract entitled “Early onset of clinical improvement with ixekizumab in patients with moderate‐severe plaque psoriasis” published in 2016 in Journal of the European Academy of Dermatology and Venereology, Vol 30 No original paper published. We emailed the study authors (3 and 12 January 2017) for the protocol and results but have not had a response.