Trials / Completed
CompletedNCT02905331
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
A Phase 3, Multicenter, Randomized, Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) Delivered Via a SelfDose (TM) Device in the Treatment of Subjects With Moderate to Severe Plaque-Type Psoriasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Guselkumab | Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device. |
| DRUG | Placebo | Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device. |
Timeline
- Start date
- 2017-02-28
- Primary completion
- 2018-02-06
- Completion
- 2018-02-06
- First posted
- 2016-09-19
- Last updated
- 2025-02-04
- Results posted
- 2018-09-06
Locations
14 sites across 3 countries: United States, Canada, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02905331. Inclusion in this directory is not an endorsement.