Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Affibody|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
Biological: - ABY-035
ABY-035 solution for injection
Biological: - Placebo
Placebo to ABY-035 solution for injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.