drugset / Trial / NCT00320216
A Safety and Effectiveness Study of CNTO 1275 in Patients With Moderate to Severe Plaque-type Psoriasis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.
Timeline
- Start
- 2003-11
- Primary completion
- 2004-06
- Completion
- 2005-03
Outcome
Met primary endpoint
paper There was at least 75% improvement in the psoriasis area-and-severity index at week 12 (the primary end point) PMID 17287478 ↗
paper in 81% of those who received four weekly 90-mg doses, as compared with 2% of those who received placebo (P<0.001 for each comparison) PMID 17287478 ↗
registry Group I: Placebo vs Group V: Ustekinumab 90 mg Weekly for 4 Weeks; p <0.001 NCT00320216 ↗
Publications
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
- Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, Wang Y, Dooley LT, Lebwohl M; CNTO 1275 Psoriasis Study Group. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med. 2007 Feb 8;356(6):580-92. doi: 10.1056/NEJMoa062382.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 45 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |