drugset / Trial / NCT01107457
A Study in Participants With Moderate to Severe Psoriasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose for this study is to help answer the following research questions * The safety of ixekizumab (LY2439821) and any side effects that might be associated with it. * Whether ixekizumab can help participants with Psoriasis. * How much ixekizumab should be given to participants.
Timeline
- Start
- 2010-04
- Primary completion
- 2011-01
- Completion
- 2016-07
Outcome
Met primary endpoint
paper percentage of patients with a reduction in the PASI score by at least 75% was significantly greater with ixekizumab (except with the lowest, 10-mg dose) PMID 22455413 ↗
paper 150 mg (82.1%), 75 mg (82.8%), and 25 mg (76.7%)--than with placebo (7.7%, P<0.001 for each comparison) PMID 22455413 ↗
registry Placebo vs 25 mg Ixekizumab; p <0.001; Mixed Models Analysis NCT01107457 ↗
Publications
- Langley RG, Rich P, Menter A, Krueger G, Goldblum O, Dutronc Y, Zhu B, Wei H, Cameron GS, Heffernan MP. Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1763-70. doi: 10.1111/jdv.12996. Epub 2015 Feb 18.
- Gordon KB, Leonardi CL, Lebwohl M, Blauvelt A, Cameron GS, Braun D, Erickson J, Heffernan M. A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2014 Dec;71(6):1176-82. doi: 10.1016/j.jaad.2014.07.048. Epub 2014 Sep 19.
- Leonardi C, Matheson R, Zachariae C, Cameron G, Li L, Edson-Heredia E, Braun D, Banerjee S. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012 Mar 29;366(13):1190-9. doi: 10.1056/NEJMoa1109997.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixekizumab | Monoclonal antibody | 10 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 25 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 80 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 120 mg | Subcutaneous |
| Subject | Ixekizumab | Monoclonal antibody | 150 mg | Subcutaneous |