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

Study Purpose

This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled, dosefinding 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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 antiphlogistic drug (NSAID) and / or DMARD.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04713072
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Affibody
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Frank Behrens
Principal Investigator Affiliation Affibody
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: ABY-035 40 mg

40 mg ABY-035 SC

Experimental: ABY-035 80 mg

80 mg ABY-035 SC

Placebo Comparator: Placebo

Placebo, switching to 80 mg ABY-035 after 16 weeks

Interventions

Biological: - ABY-035

ABY-035 solution for injection

Biological: - Placebo

Placebo to ABY-035 solution for injection

Contact a Trial Team

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International Sites

Frankfurt am Main, Germany

Status

Recruiting

Address

Centrum für innovative Diagnostik und Therapie Rheumatologie / Immunologie (CIRI GmbH)

Frankfurt am Main, ,

Site Contact

Frank Behrens

[email protected]

+46705415413

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