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

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713072
• Other study ID #: ABY-035-202
• Status: Completed
• Phase: Phase 2
• Start date: August 4, 2020
• Est. completion date: January 27, 2022

Study information

• Verified date: November 2022
• Source: ACELYRIN Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 27, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• ABY-035
ABY-035 solution for injection
• Placebo
Placebo to ABY-035 solution for injection

Locations

Country	Name	City	State
Austria	LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie	Graz
Austria	Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II	Innsbruck
Austria	Vienna Medical University Department of Internal Medicine III Division of Rheumatology	Vienna
Belgium	Katholieke Universiteit Leuven	Leuven
Czechia	VESALION s.r.o.	Ostrava
Czechia	Revmatologický ústav	Praha
Czechia	MEDICAL PLUS s.r.o.	Uherské Hradište
Czechia	PV Medical Services s.r.o.	Zlín
Germany	Rheumatologische Schwerpunktpraxis	Berlin
Germany	Schlosspark Klinik	Berlin
Germany	Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie	Frankfurt
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Rheumazentrum Ruhrgebiet Herne	Herne
Germany	Klinikum der Universität München Rheumatologie	München
Germany	Rheumazentrum Ratingen	Ratingen
Hungary	Qualiclinic Kft.	Budapest
Hungary	CRU Hungary Ltd	Miskolc
Hungary	MÁV Kórház és Rendelointézet, Reumtólegia	Szolnok
Hungary	Vital Medical Center	Veszprém
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	PRATIA MCM Krakow	Kraków
Poland	Centrum Medyczne AMED oddzial w Lodzi	Lódz
Poland	ETYKA Osrodek Badan Klinicznych	Olsztyn
Poland	ETG Skierniewice	Skierniewice
Poland	Centrum Medyczne AMED	Warsaw
Poland	ETG Warszawa	Warsaw
Spain	Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC	Córdoba
Spain	Complejo Hospitalario Universitario de A Coruña	Coruña
Spain	Cliníca Ceta - Unidad de Ensayos Clínicos	Madrid
Spain	Hospital Parc Tauli de Sabadell	Sabadell
Spain	Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario	Santiago De Compostela
Spain	Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 50 response rate (ACR50)	ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo	16 weeks
Primary	ACR50	ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo	12 weeks
Secondary	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
Secondary	ACR20/70	ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo	12 weeks
Secondary	ACR20/50/70	ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo	16 weeks
Secondary	ACR20/50/70	ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo	12 weeks
Secondary	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