NCT03591887

A Study to Evaluate ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis

A Phase II, Randomized, Parallel Group, Placebo-controlled, Double-blinded, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of ABY-035 in Subjects With Moderate-to-severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Affibody · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The Core study evaluates four doses of ABY-035, in comparison to placebo, in subjects with moderate to severe plaque psoriasis. The treatment periods in the Core study are: * Induction (Week 0-12) - four dose levels and placebo (Q2W) * Optimization (Week 12-24) - starting with a possible dose adjustment (all subjects on Q2W) depending on PASI score. Subjects on placebo switch to active drug (Q4W). * Individualization (Week 24-52) - starting with a switch to Q4W for all subjects. From week 32 dosing interval alters depending on PASI score. The study is unblinded after completion of the Core study. During the optional Extension and Prolongation of Extension periods, dose levels and intervals alter depending on PASI score.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	ABY-035	ABY-035 solution for injection
BIOLOGICAL	Placebo	Placebo to ABY-035 solution for injection

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-03-27
• Completion: 2021-12-03
• First posted: 2018-07-19
• Last updated: 2023-06-08

Locations

18 sites across 1 country: Germany