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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABY-035 40 mg | Experimental | 40 mg ABY-035 SC |
|
| ABY-035 80 mg | Experimental | 80 mg ABY-035 SC |
|
| Placebo | Placebo Comparator | Placebo, switching to 80 mg ABY-035 after 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABY-035 | Biological | ABY-035 solution for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| ACR20/70 | ACR20/70 response rate, percentage of patients achieving MDA: at V7 (Week 12) for higher Dose vs. Placebo |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myreen Tomas, MD | ACELYRIN Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie | Graz | 8036 | Austria |
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| Placebo |
| Biological |
Placebo to ABY-035 solution for injection |
|
| 12 weeks |
| ACR20/50/70 | ACR20/50/70 response rate, percentage of patients achieving MDA: at V9 (Week 16) for Lower Dose vs. Placebo | 16 weeks |
| ACR20/50/70 | 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 | ACR 20/50/70 response rate, percentage of patients achieving MDA: at V5 (Week 8) for higher Dose vs. Placebo | 8 weeks |
| Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II | Innsbruck | 6020 | Austria |
| Vienna Medical University Department of Internal Medicine III Division of Rheumatology | Vienna | 1090 | Austria |
| Katholieke Universiteit Leuven | Leuven | 3000 | Belgium |
| VESALION s.r.o. | Ostrava | 702 00 | Czechia |
| Revmatologický ústav | Prague | 128 00 | Czechia |
| MEDICAL PLUS s.r.o. | Uherské Hradiště | Czechia |
| PV Medical Services s.r.o. | Zlín | 760 01 | Czechia |
| Rheumatologische Schwerpunktpraxis | Berlin | 12161 | Germany |
| Schlosspark Klinik | Berlin | 14059 | Germany |
| Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie | Frankfurt | 60590 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Rheumazentrum Ruhrgebiet Herne | Herne | 79106 | Germany |
| Klinikum der Universität München Rheumatologie | München | 80336 | Germany |
| Rheumazentrum Ratingen | Ratingen | 40878 | Germany |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| CRU Hungary Ltd | Miskolc | 3529 | Hungary |
| MÁV Kórház és Rendelőintézet, Reumtólegia | Szolnok | 5000 | Hungary |
| Vital Medical Center | Veszprém | 8200 | Hungary |
| Nasz Lekarz Ośrodek Badań Klinicznych | Bydgoszcz | 85-065 | Poland |
| PRATIA MCM Krakow | Krakow | 30-510 | Poland |
| Centrum Medyczne AMED oddział w Łodzi | Lodz | 91-363 | Poland |
| ETYKA Ośrodek Badań Klinicznych | Olsztyn | 10-117 | Poland |
| ETG Skierniewice | Skierniewice | 96-100 | Poland |
| ETG Warszawa | Warsaw | 02-793 | Poland |
| Centrum Medyczne AMED | Warsaw | 03-291 | Poland |
| Complejo Hospitalario Universitario de A Coruña | A Coruña | 15006 | Spain |
| Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC | Córdoba | 14004 | Spain |
| Cliníca Ceta - Unidad de Ensayos Clínicos | Madrid | 28915 | Spain |
| Hospital Parc Tauli de Sabadell | Sabadell | 8208 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario | Santiago de Compostela | 15706 | Spain |
| Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología | Seville | 41011 | Spain |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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