A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis

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

This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of ABY-035 in adult patients with PsA.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Biological: ABY-035; Biological: Placebo

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
  • Vienna, Austria, 1090
    • Vienna Medical University Department of Internal Medicine III Division of Rheumatology
• Belgium
  • Leuven, Belgium, 3000
    • Katholieke Universiteit Leuven
• Czechia
  • Ostrava, Czechia, 702 00
    • Vesalion s.r.o.
  • Praha, Czechia, 128 00
    • Revmatologicky Ustav
  • Uherské Hradiště, Czechia
    • MEDICAL Plus s.r.o.
  • Zlín, Czechia, 760 01
    • PV Medical Services s.r.o.
• Germany
  • Berlin, Germany, 12161
    • Rheumatologische Schwerpunktpraxis
  • Berlin, Germany, 14059
    • Schlosspark Klinik
  • Frankfurt, Germany, 60590
    • Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Herne, Germany, 79106
    • Rheumazentrum Ruhrgebiet Herne
  • München, Germany, 80336
    • Klinikum der Universität München Rheumatologie
  • Ratingen, Germany, 40878
    • Rheumazentrum Ratingen
• Hungary
  • Budapest, Hungary, 1036
    • Qualiclinic Kft.
  • Miskolc, Hungary, 3529
    • CRU Hungary Ltd
  • Szolnok, Hungary, 5000
    • MÁV Kórház és Rendelőintézet, Reumtólegia
  • Veszprém, Hungary, 8200
    • Vital Medical Center
• Poland
  • Bydgoszcz, Poland, 85-065
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Kraków, Poland, 30-510
    • PRATIA MCM Kraków
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych
  • Skierniewice, Poland, 96-100
    • ETG Skierniewice
  • Warsaw, Poland, 02-793
    • ETG Warszawa
  • Warsaw, Poland, 03-291
    • Centrum Medyczne AMED
  • Łódź, Poland, 91-363
    • Centrum Medyczne AMED oddział w Łodzi
• Spain
  • Coruña, Spain, 15006
    • Complejo Hospitalario Universitario de A Coruña
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC
  • Madrid, Spain, 28915
    • Cliníca Ceta - Unidad de Ensayos Clínicos
  • Sabadell, Spain, 8208
    • Hospital Parc Taulí de Sabadell
  • Santiago De Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario
  • Sevilla, Spain, 41011
    • Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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:
• ≥3 swollen joints out of 66 joints (SJC66) at Screening visit and Baseline visit
• ≥3 tender joints out of 68 (TJC68) at Screening visit and Baseline visit
• Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal anti-inflammatory drug (NSAID), csDMARD (i.e. MTX, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A), and/or TNFi (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab)
• Rheumatoid factor (RF) and anti-CCP antibody negative
• Presence or history of plaque psoriasis

Exclusion Criteria:

• 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
• Presence or history of recurrent or medically important infections in the last 6 months prior to Baseline visit
• Clinically relevant Candida infection requiring systemic treatment within the last 6 months prior to Baseline visit
• History or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years
• Insufficiently controlled heart failure
• Current uncontrolled arterial hyper- or hypotension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABY-035 80 mg; 80 mg ABY-035 SC	Biological: ABY-035; ABY-035 solution for injection
Experimental: ABY-035 40 mg; 40 mg ABY-035 SC	Biological: ABY-035; ABY-035 solution for injection
Placebo Comparator: Placebo; Placebo, switching to 80 mg ABY-035 after 16 weeks	Biological: Placebo; Placebo to ABY-035 solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American College of Rheumatology 50 response rate (ACR50)	ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo	16 weeks
ACR50	ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR20/70	ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo	16 weeks
ACR20/70	ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo	12 weeks
ACR20/50/70	ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo	16 weeks
ACR20/50/70	ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo	12 weeks
ACR 20/50/70	ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo	8 weeks

Collaborators and Investigators

• Sponsor: ACELYRIN Inc.
• Investigators: Study Director: Myreen Tomas, MD, ACELYRIN Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): January 27, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: ABY-035-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No