Back to resultsA Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABY-035
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility Criteria
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
Sites / Locations
- LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
- Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
- Vienna Medical University Department of Internal Medicine III Division of Rheumatology
- Katholieke Universiteit Leuven
- VESALION s.r.o.
- Revmatologický ústav
- MEDICAL PLUS s.r.o.
- PV Medical Services s.r.o.
- Rheumatologische Schwerpunktpraxis
- Schlosspark Klinik
- Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie
- Universitätsklinikum Freiburg
- Rheumazentrum Ruhrgebiet Herne
- Klinikum der Universität München Rheumatologie
- Rheumazentrum Ratingen
- Qualiclinic Kft.
- CRU Hungary Ltd
- MÁV Kórház és Rendelőintézet, Reumtólegia
- Vital Medical Center
- Nasz Lekarz Ośrodek Badań Klinicznych
- PRATIA MCM Krakow
- ETYKA Ośrodek Badań Klinicznych
- ETG Skierniewice
- ETG Warszawa
- Centrum Medyczne AMED
- Centrum Medyczne AMED oddział w Łodzi
- Complejo Hospitalario Universitario de A Coruña
- Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC
- Cliníca Ceta - Unidad de Ensayos Clínicos
- Hospital Parc Tauli de Sabadell
- Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario
- Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ABY-035 40 mg
ABY-035 80 mg
Placebo
Arm Description
40 mg ABY-035 SC
80 mg ABY-035 SC
Placebo, switching to 80 mg ABY-035 after 16 weeks
Outcomes
Primary Outcome Measures
American College of Rheumatology 50 response rate (ACR50)
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
Secondary Outcome Measures
ACR20/70
ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo
ACR20/70
ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo
ACR20/50/70
ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo
ACR 20/50/70
ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04713072
Brief Title
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
January 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACELYRIN Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABY-035 40 mg
Arm Type
Experimental
Arm Description
40 mg ABY-035 SC
Arm Title
ABY-035 80 mg
Arm Type
Experimental
Arm Description
80 mg ABY-035 SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, switching to 80 mg ABY-035 after 16 weeks
Intervention Type
Biological
Intervention Name(s)
ABY-035
Intervention Description
ABY-035 solution for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo to ABY-035 solution for injection
Primary Outcome Measure Information:
Title
American College of Rheumatology 50 response rate (ACR50)
Description
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
Time Frame
16 weeks
Title
ACR50
Description
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ACR20/70
Description
ACR20/70 response rate, percentage of patients achieving Minimal Disease Activity (MDA): at V9 (Week 16) for higher Dose vs. Placebo
Time Frame
16 weeks
Title
ACR20/70
Description
ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo
Time Frame
12 weeks
Title
ACR20/50/70
Description
ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo
Time Frame
16 weeks
Title
ACR20/50/70
Description
ACR20/50/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for Lower Dose vs. Placebo
Time Frame
12 weeks
Title
ACR 20/50/70
Description
ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apinya Lert, MD
Organizational Affiliation
ACELYRIN Inc.
Official's Role
Study Director
Facility Information:
Facility Name
LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Vienna Medical University Department of Internal Medicine III Division of Rheumatology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Katholieke Universiteit Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
VESALION s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Revmatologický ústav
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
MEDICAL PLUS s.r.o.
City
Uherské Hradiště
Country
Czechia
Facility Name
PV Medical Services s.r.o.
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Rheumatologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Schlosspark Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet Herne
City
Herne
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum der Universität München Rheumatologie
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Rheumazentrum Ratingen
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
CRU Hungary Ltd
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
MÁV Kórház és Rendelőintézet, Reumtólegia
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Nasz Lekarz Ośrodek Badań Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
PRATIA MCM Krakow
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
ETYKA Ośrodek Badań Klinicznych
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Facility Name
ETG Skierniewice
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
ETG Warszawa
City
Warsaw
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warsaw
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Centrum Medyczne AMED oddział w Łodzi
City
Łódź
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Complejo Hospitalario Universitario de A Coruña
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Cliníca Ceta - Unidad de Ensayos Clínicos
City
Madrid
ZIP/Postal Code
28915
Country
Spain
Facility Name
Hospital Parc Tauli de Sabadell
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología
City
Sevilla
ZIP/Postal Code
41011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
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