A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis
NCT03591887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2023-06-08
Summary
This randomized, double-blinded dose-finding study evaluates four dose levels of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis.
The study consists of 52-week Core study and two optional 52-week periods, Extension and Prolongation of Extension.
The Core study consists of three periods: Induction (placebo-controlled, Week 0-12), Optimization (Week 12-24), and Individualization (Week 24-52).
Conditions
Interventions
- BIOLOGICAL
-
ABY-035
ABY-035 solution for injection
- BIOLOGICAL
-
Placebo to ABY-035 solution for injection
Sponsors & Collaborators
-
TFS Trial Form Support
collaborator INDUSTRY -
Affibody
lead INDUSTRY
Principal Investigators
-
Sascha Gerdes, Dr. med · Klinik für Dermatologie, Venerologie und Allergologie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-07
- Primary Completion
- 2019-03-27
- Completion
- 2021-12-03
Countries
- Germany
Study Locations
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