Biotech company conducts a clinical trial of ABY-035 in Patients With Active Psoriatic Arthritis

Affibody is recruiting patients for the clinical trial of A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis.

This is 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 ABY-035 drug molecule is a selective inhibitor of interleukin 17A (IL-17A) that binds with high affinity and with a potency corresponding to clinically tested monoclonal antibodies in terms of blocking the biological activity of IL-17A. ABY-035 has the potential to be an efficacious treatment for a variety of IL-17A-related diseases, including psoriasis and psoriatic arthritis.

The indicative completion of the clinical trial will be expected in June 2022.

The study will take place at the Centrum für innovative Diagnostik und Therapie Rheumatologie / Immunologie (CIRI GmbH), Frankfurt am Main, Germany.

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.
  • Precedent failure or insufficient treatment response to or contraindication or intolerability to nonsteroidal antiphlogistic drug (NSAID) and / or DMARD.
  • Rheumatoid factor (RF) and anti-CCP antibody negative.
  • Presence or history of plaque psoriasis.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04713072

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