WHO ICTRP trial

A double-blind study in subjects with active psoriatic arthritis to evaluate…

EUCTR2019-003405-94-HU · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2019-003405-94-HU
Public title A double-blind study in subjects with active psoriatic arthritis to evaluate efficacy, tolerability, safety of two different dose levels of ABY-035 compared to placebo.
Scientific title A multicenter, randomized, double-blind, placebo-controlled, dose-finding clinical trial inpatients with active psoriatic arthritis to investigate efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035
Primary sponsor Affibody AB
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Czechia;Hungary;Spain;Poland;Belgium;Austria;Germany;Sweden
Conditions Active Psoriatic Arthritis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Interventions Product Name: ABY-035 Pharmaceutical Form: Solution for injection CAS Number: 2226130-02-3 Current Sponsor code: ABY-035 Other descriptive name: Recombinant protein comprising two IL-17A binding domains and an albumin binding domain…
Registration date Nov 21, 2019
Target size 129
Secondary IDs ABY-035-202
Registry page clinicaltrialsregister.eu

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