A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Plaque Psoriasis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The study consists of a four week screening period, three treatment periods and a four-week follow-up period. The treatment periods are: Randomized treatment; four dose le...
The study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The study consists of a four week screening period, three treatment periods and a four-week follow-up period. The treatment periods are: Randomized treatment; four dose levels and placebo. Biweekly (Q2W) administration during during 12 weeks. Administration Q2W during during 12 weeks, starting with a possible dose adjustment depending on the achieved absolute PASI score. Subjects on placebo are switched to active drug every 4 weeks (Q4W). Administration Q4W, starting with a possible dose adjustment , depending on the achieved absolute PASI score. The dosing interval is varied between Q4W and Q8W, depending on the PASI score.
Tracking Information
- NCT #
- NCT03591887
- Collaborators
- TFS Trial Form Support
- Investigators
- Principal Investigator: Sascha Gerdes, Dr. med Klinik für Dermatologie, Venerologie und Allergologie
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