NCT04713072

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2

Geographic Reach
7 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
Last Updated

February 9, 2024

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

January 14, 2021

Last Update Submit

February 8, 2024

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • ACR20/70

    16 weeks

  • ACR20/70

    12 weeks

  • ACR20/50/70

    16 weeks

  • ACR20/50/70

    12 weeks

  • ACR 20/50/70

    8 weeks

Study Arms (3)

ABY-035 40 mg

EXPERIMENTAL

40 mg ABY-035 SC

Biological: ABY-035

ABY-035 80 mg

EXPERIMENTAL

80 mg ABY-035 SC

Biological: ABY-035

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

ABY-035BIOLOGICAL

ABY-035 solution for injection

ABY-035 40 mgABY-035 80 mg
PlaceboBIOLOGICAL

Placebo to ABY-035 solution for injection

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

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

Graz, 8036, Austria

Location

Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II

Innsbruck, 6020, Austria

Location

Vienna Medical University Department of Internal Medicine III Division of Rheumatology

Vienna, 1090, Austria

Location

Katholieke Universiteit Leuven

Leuven, 3000, Belgium

Location

VESALION s.r.o.

Ostrava, 702 00, Czechia

Location

Revmatologický ústav

Prague, 128 00, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Location

PV Medical Services s.r.o.

Zlín, 760 01, Czechia

Location

Rheumatologische Schwerpunktpraxis

Berlin, 12161, Germany

Location

Schlosspark Klinik

Berlin, 14059, Germany

Location

Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie

Frankfurt, 60590, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Rheumazentrum Ruhrgebiet Herne

Herne, 79106, Germany

Location

Klinikum der Universität München Rheumatologie

München, 80336, Germany

Location

Rheumazentrum Ratingen

Ratingen, 40878, Germany

Location

Qualiclinic Kft.

Budapest, 1036, Hungary

Location

CRU Hungary Ltd

Miskolc, 3529, Hungary

Location

MÁV Kórház és Rendelőintézet, Reumtólegia

Szolnok, 5000, Hungary

Location

Vital Medical Center

Veszprém, 8200, Hungary

Location

Nasz Lekarz Ośrodek Badań Klinicznych

Bydgoszcz, 85-065, Poland

Location

PRATIA MCM Krakow

Krakow, 30-510, Poland

Location

Centrum Medyczne AMED oddział w Łodzi

Lodz, 91-363, Poland

Location

ETYKA Ośrodek Badań Klinicznych

Olsztyn, 10-117, Poland

Location

ETG Skierniewice

Skierniewice, 96-100, Poland

Location

ETG Warszawa

Warsaw, 02-793, Poland

Location

Centrum Medyczne AMED

Warsaw, 03-291, Poland

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC

Córdoba, 14004, Spain

Location

Cliníca Ceta - Unidad de Ensayos Clínicos

Madrid, 28915, Spain

Location

Hospital Parc Tauli de Sabadell

Sabadell, 8208, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario

Santiago de Compostela, 15706, Spain

Location

Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología

Seville, 41011, Spain

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Myreen Tomas, MD

    ACELYRIN Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

August 4, 2020

Primary Completion

October 1, 2021

Study Completion

January 27, 2022

Last Updated

February 9, 2024

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(4)DE(7)PL(7)AU(3)BE(1)HU(4)ES(6)