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

February 8, 2024 updated by: ACELYRIN Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Universitatsklinikum 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 Krakow
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 50 response rate (ACR50)
Time Frame: 16 weeks
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
16 weeks
ACR50
Time Frame: 12 weeks
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ACR20/70
Time Frame: 16 weeks
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
Time Frame: 12 weeks
ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
12 weeks
ACR20/50/70
Time Frame: 16 weeks
ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo
16 weeks
ACR20/50/70
Time Frame: 12 weeks
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
Time Frame: 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ACELYRIN Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Myreen Tomas, MD, ACELYRIN Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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