Clinical trial NCT04713072: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: ACELYRIN Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: American College of Rheumatology 50 response rate (ACR50)
timeFrame: 16 weeks
measure: ACR50
timeFrame: 12 weeks
Secondary outcomes:
measure: ACR20/70
timeFrame: 16 weeks
measure: ACR20/70
timeFrame: 12 weeks
measure: ACR20/50/70
timeFrame: 16 weeks
measure: ACR20/50/70
timeFrame: 12 weeks
measure: ACR 20/50/70
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Rheumatologie und Immunologie
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck/Tirol Kliniken GmbH Universitätsklinik für Innere Medizin II
city: Vienna
country: Austria
facility: Vienna Medical University Department of Internal Medicine III Division of Rheumatology
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Ostrava
country: Czechia
facility: VESALION s.r.o.
city: Praha
country: Czechia
facility: Revmatologický ústav
city: Uherské Hradiště
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Zlín
country: Czechia
facility: PV Medical Services s.r.o.
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Schlosspark Klinik
city: Frankfurt
country: Germany
facility: Centrum für Innovative Diagnostik und Therapie Rheumatologie/Immunologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet Herne
city: München
country: Germany
facility: Klinikum der Universität München Rheumatologie
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd
city: Szolnok
country: Hungary
facility: MÁV Kórház és Rendelőintézet, Reumtólegia
city: Veszprém
country: Hungary
facility: Vital Medical Center
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Ośrodek Badań Klinicznych
city: Kraków
country: Poland
facility: PRATIA MCM Krakow
city: Olsztyn
country: Poland
facility: ETYKA Ośrodek Badań Klinicznych
city: Skierniewice
country: Poland
facility: ETG Skierniewice
city: Warsaw
country: Poland
facility: ETG Warszawa
city: Warsaw
country: Poland
facility: Centrum Medyczne AMED
city: Łódź
country: Poland
facility: Centrum Medyczne AMED oddział w Łodzi
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía 1 Planta Derecha Servicio Reumatología- IMIBIC
city: Madrid
country: Spain
facility: Cliníca Ceta - Unidad de Ensayos Clínicos
city: Sabadell
country: Spain
facility: Hospital Parc Tauli de Sabadell
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela Hospital Clinico Universitario
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa Unidad De Investigación De Reumatología
Study officials:
affiliation: ACELYRIN Inc.
name: Myreen Tomas, MD
role: STUDY_DIRECTOR
References: