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

Phase 2

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Biological: Placebo; Biological: ABY-035

• Registration Number: NCT04713072
• Lead Sponsor: ACELYRIN Inc.

Brief Summary

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-04
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Primary Completion: 2021-10-01
• Study Completion: 2022-01-27
• Status Verified: 2022-11
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, switching to 80 mg ABY-035 after 16 weeks
ABY-035 40 mg	ABY-035	40 mg ABY-035 SC
ABY-035 80 mg	ABY-035	80 mg ABY-035 SC

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ACR20/70	12 weeks	ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
ACR20/50/70	12 weeks	ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo
ACR 20/50/70	8 weeks	ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo

Trial Locations

Locations (32)

Revmatologický ústav; 🇨🇿 Praha, Czechia

Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II; 🇦🇹 Innsbruck, Austria

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 Coruña, Spain

CRU Hungary Ltd; 🇭🇺 Miskolc, Hungary

Qualiclinic Kft.; 🇭🇺 Budapest, Hungary

LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie; 🇦🇹 Graz, Austria

Rheumatologische Schwerpunktpraxis; 🇩🇪 Berlin, Germany

PRATIA MCM Krakow; 🇵🇱 Kraków, Poland

Vital Medical Center; 🇭🇺 Veszprém, Hungary

Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie; 🇩🇪 Frankfurt, Germany

MEDICAL PLUS s.r.o.; 🇨🇿 Uherské Hradiště, Czechia

Schlosspark Klinik; 🇩🇪 Berlin, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

MÁV Kórház és Rendelőintézet, Reumtólegia; 🇭🇺 Szolnok, Hungary

Rheumazentrum Ruhrgebiet Herne; 🇩🇪 Herne, Germany

Rheumazentrum Ratingen; 🇩🇪 Ratingen, Germany

Hospital Parc Tauli de Sabadell; 🇪🇸 Sabadell, Spain

ETG Warszawa; 🇵🇱 Warsaw, Poland

Cliníca Ceta - Unidad de Ensayos Clínicos; 🇪🇸 Madrid, Spain

Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC; 🇪🇸 Córdoba, Spain

Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología; 🇪🇸 Sevilla, Spain

PV Medical Services s.r.o.; 🇨🇿 Zlín, Czechia

Vienna Medical University Department of Internal Medicine III Division of Rheumatology; 🇦🇹 Vienna, Austria

VESALION s.r.o.; 🇨🇿 Ostrava, Czechia

Klinikum der Universität München Rheumatologie; 🇩🇪 München, Germany

Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario; 🇪🇸 Santiago De Compostela, Spain

ETG Skierniewice; 🇵🇱 Skierniewice, Poland

ETYKA Ośrodek Badań Klinicznych; 🇵🇱 Olsztyn, Poland

Centrum Medyczne AMED; 🇵🇱 Warsaw, Poland

Centrum Medyczne AMED oddział w Łodzi; 🇵🇱 Łódź, Poland

Nasz Lekarz Ośrodek Badań Klinicznych; 🇵🇱 Bydgoszcz, Poland

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium