Completed

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035

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What is being tested

ABY-035

+ Placebo

Biological
Who is being recruted

Arthritis+10

+ Bone Diseases

+ Joint Diseases

From 18 to 75 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2020
See protocol details

Summary

Principal SponsorACELYRIN Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 4, 2020

Actual date on which the first participant was enrolled.

The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit) comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of follow-up. Treatment Periods are: * Treatment Period I: from V1 (Week 0) to V9 (Week 16) * Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing) At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal rates (1:1:1) to one of three parallel groups (A, B, C). The treatment will be administered once every 2 weeks (Q2W). Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A = 40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80 mg ABY-035 from V9 to V16).

Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Clinical Trial in Patients With Active Psoriatic Arthritis to Investigate Efficacy, Tolerability, Safety, Pharmacokinetics and Immunogenicity of ABY-035
NCT04713072
Principal SponsorACELYRIN Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

129 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesPsoriasisSkin DiseasesSpinal DiseasesSpondylitisArthritis, PsoriaticSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathies

Criteria

9 inclusion criteria required to participate
Patient who has given his / her signed declaration of consent and data protection declaration
At least 18 years and less than 75 years of age at Screening visit
Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ≥3 points from the five categories of the Classification Criteria for Psoriatic Arthritis (CASPAR) at any timepoint in medical history.
Active psoriatic arthritis defined by:
Show More Criteria
9 exclusion criteria prevent from participating
Underlying conditions which significantly immunocompromise the patient and / or place the patient at unacceptable risk for receiving an immunomodulatory therapy
History of or current relevant autoimmune diseases (e.g. rheumatoid arthritis, primary ankylosing spondylitis, systemic lupus erythematosus) other than psoriasis or psoriatic arthritis
History of or current fibromyalgia or pain syndrome
Uncontrolled inflammatory bowel disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
40 mg ABY-035 SC

Group II

Experimental
80 mg ABY-035 SC

Group III

Placebo
Placebo, switching to 80 mg ABY-035 after 16 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Suspended

Rheumazentrum Ratingen

Ratingen, GermanyOpen Rheumazentrum Ratingen in Google Maps
Suspended

Qualiclinic Kft.

Budapest, Hungary
Suspended

CRU Hungary Ltd

Miskolc, Hungary
Suspended

LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie

Graz, Austria
Completed32 Study Centers