NCT02899962

LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 722 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris. A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Detailed description

After an initial 4-week period of once-daily treatment with open-label active LEO 90100 aerosol foam, subjects who qualify for randomisation will continue into a 52-week maintenance treatment period with twice-weekly application of randomised LEO 90100 aerosol foam / LEO 90100 aerosol foam vehicle. If the subject experiences a relapse of psoriasis, the active lesions will be treated for 4 weeks with open-label active LEO 90100 aerosol foam.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	LEO 90100 aerosol foam	LEO 90100 aerosol foam twice weekly
DRUG	LEO 90100 aerosol foam vehicle	LEO 90100 aerosol foam vehicle twice weekly

Timeline

• Start date: 2017-02-15
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2016-09-14
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

58 sites across 6 countries: United States, Canada, France, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study