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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Sylvia
Vetrhus
+47 922 01 571
sylvia.vetrhus@arxxtx.com
Prof
Dave
Singh
+44 (0)161 946 4073
dsingh@meu.org.uk
Dr
Jonas
Hallén
+47 92826003
jonas.hallen@arxxtx.com
Healthy volunteers and patients with mild to moderate chronic plaque psoriasis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The Sponsor, Arxx Therapeutics, is developing a new experimental medication called AX-202 for the purpose of treating inflammatory diseases (when the immune system attacks the body's own tissues, resulting in inflammation) and fibrotic diseases (diseases caused by the thickening or scarring of tissue). Psoriasis is a chronic, relapsing inflammatory disease of the skin affecting approximately 1-3% of the world’s population. The most common form is plaque psoriasis representing 80-90% of all cases. Plaque psoriasis is defined by well-defined red, scaly plaques or patches which can occur anywhere on the body. The immune system normally defends the body against harmful substances, diseases and infections. However, in people who have an autoimmune disease such as psoriasis, the immune system becomes overactive and attacks its own healthy cells. S100A4 is a protein released in the body which can cause harm, contributing to over-activation of the immune system (inflammation) and tissue damage in diseases like psoriasis. AX-202 is a type of medication called a ‘monoclonal antibody’, which are antibodies designed to specifically bind to a disease-causing protein. AX-202 binds to and blocks the activity of S100A4, so may reduce inflammation and tissue damage in psoriasis.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current exclusion criteria as of 03/03/2023:Part A1. History/presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject’s safety or expose the subject to undue risk as judged by the Investigator.2. Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months.3. Smoking history of > 5 pack years. 4. Positive urine cotinine test at screening or Day -1.
Part B1. History/presence of any clinically relevant acute or chronic medical or psychiatric condition other than psoriasis that could interfere with the patient’s safety or expose the patient to undue risk as judged by the Investigator.2. A diagnosis of non-plaque psoriasis.3. Plaque psoriasis restricted to the scalp, palms, soles and face.4. Pustular, erythrodermic, inverse and guttate psoriasis.5. Drug-induced psoriasis.6. Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a patient requires current systemic immunosuppressant medical treatment.7. Presence of other skin conditions that could interfere with psoriasis evaluation or assessments. 8. Sunbed use in the 4 weeks prior to screening or planned use prior to the final study visit. 9. Any clinically significant infection requiring antimicrobial treatment in the 2 weeks prior to Day 1.
Parts A & B1. After a min 10 minutes supine rest at the time of screening or on Day -1: 1.1. Systolic blood pressure <90 or >140 mmHg, or 1.2. Diastolic blood pressure <50 or >90 mmHg, or 1.3. Pulse <40 or >90 bpm 2. Any clinically significant abnormalities in ECG at the time of screening or on Day -1 incl. prolonged QTcF (>450 ms for males; >470 ms for females) and cardiac arrhythmias, as judged by the Investigator.3. Clinically significant abnormalities in renal function at screening including:eGFR <60 mL/min4. Clinically significant abnormalities in liver function at screening including:4.1. Bilirubin >1.0 x ULN4.2. Aminotransferases >1.0 x ULN4.3. ALP >1.0 x ULN 5. Haemoglobin <130 g/l for males or <120 g/l for females at screening6. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first dose of IMP.7. Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps. 8. Any planned major surgery within the duration of the study or in the 30 days following study completion.9. History of latent or active tuberculosis or a positive Quantiferon test at screening. Patients with an indeterminate result at screening will be allowed one retest; if not negative on retesting, the subject will be excluded.10. Females who are pregnant, breastfeeding, lactating or plan to be pregnant during the study period or 120 days after. 11. Female subjects with a positive serum or urine pregnancy test at screening or on Day -1. 12. Positive serum HBsAg, HCVAb or HIV 1 and/or 2 antibodies at screening. 13. A Positive test for active COVID-19 prior to dosing on Day 1. 14. History of any drug and/or alcohol abuse in the 2 years prior to screening.15. Regular alcohol consumption of >14 units per week.16. Positive urine drugs of abuse test and/or alcohol breath test at screening or on Day -1 that cannot be accounted for by concomitant medication in the opinion of the Investigator. 17. Receiving any of the prohibited concomitant medications.18. Plasma donation within one month of screening, blood donation (or corresponding blood loss) ≥400ml during the three months prior to screening or planned donation during the study until 4 months after the final study visit.19. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or designee at screen.20. Subject has dietary restrictions incompatible with the diet that can be provided by the study site, in the opinion of the Investigator or is unwilling to refrain from consuming restricted foods and beverages during the study.21. Regular excessive caffeine consumption defined as a daily intake of >5 cups of caffeine-containing beverages. 22. Known history of intolerance or hypersensitivity to AX-202 or to any other component of the formulation.23. Known history of intolerance to placebo or excipients.24. Clinically significant serious adverse reaction, allergy or serious hypersensitivity, including to any drug or food, as judged by the Investigator.25. Involvement in the planning and conduct of the study.26. Participation in another clinical study with an experimental drug within 3 months (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the administration of IMP.27. Considered unsuitable for entry into the study in any other way at the discretion of the Investigator, e.g. Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
Previous exclusion criteria:Part A1. History/presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject’s safety or expose the subject to undue risk as judged by the Investigator.2. Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months.3. Smoking history of > 5 pack years. 4. Positive urine cotinine test at screening or Day -1.
Part B 1. History/presence of any clinically relevant acute or chronic medical or psychiatric condition other than psoriasis that could interfere with the patient’s safety or expose the patient to undue risk as judged by the Investigator.2. A diagnosis of non-plaque psoriasis.3. Plaque psoriasis restricted to the scalp, palms, soles and face.4. Pustular, erythrodermic, inverse and guttate psoriasis.5. Drug-induced psoriasis.6. Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a patient requires current systemic immunosuppressant medical treatment.7. Presence of other skin conditions that could interfere with psoriasis evaluation or assessments. 8. Sunbed use in the 4 weeks prior to screening or planned use prior to the final study visit. 9. Any clinically significant infection requiring antimicrobial treatment in the 2 weeks prior to Day 1.
Parts A & B1. After a min 10 minutes supine rest at the time of screening or on Day -1: 1.1. Systolic blood pressure <90 or >150 mmHg, or 1.2. Diastolic blood pressure <50 or >95 mmHg, or 1.3. Pulse <40 or >90 bpm 2. Any clinically significant abnormalities in ECG at the time of screening or on Day -1 incl. prolonged QTcF (>450 ms for males; >470 ms for females) and cardiac arrhythmias, as judged by the Investigator.3. Clinically significant abnormalities in renal function at screening including:eGFR <60 mL/min4. Clinically significant abnormalities in liver function at screening including:4.1. Bilirubin >1.5 x ULN4.2. Aminotransferases >1.5 x ULN (Part A) or > 2 x ULN (Part B)4.3 ALP >1.5 x ULN5. Haemoglobin < 10 g/dL at screening.6. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first dose of IMP.7. Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps. 8. Any planned major surgery within the duration of the study or in the 30 days following study completion.9. History of latent or active tuberculosis or a positive Quantiferon test at screening. Patients with an indeterminate result at screening will be allowed one retest; if not negative on retesting, the subject will be excluded.10. Females who are pregnant, breastfeeding, lactating or plan to be pregnant during the study period or 120 days after. 11. Female subjects with a positive serum or urine pregnancy test at screening or on Day -1. 12. Positive serum HBsAg, HCVAb or HIV 1 and/or 2 antibodies at screening. 13. A Positive test for active COVID-19 prior to dosing on Day 1. 14. History of any drug and/or alcohol abuse in the 2 years prior to screening.15. Regular alcohol consumption of >14 units per week.16. Positive urine drugs of abuse test and/or alcohol breath test at screening or on Day -1 that cannot be accounted for by concomitant medication in the opinion of the Investigator. 17. Receiving any of the prohibited concomitant medications.18. Plasma donation within one month of screening, blood donation (or corresponding blood loss) ≥400ml during the three months prior to screening or planned donation during the study until 4 months after the final study visit.19. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator or designee at screen.20. Subject has dietary restrictions incompatible with the diet that can be provided by the study site, in the opinion of the Investigator or is unwilling to refrain from consuming restricted foods and beverages during the study.21. Regular excessive caffeine consumption defined as a daily intake of >5 cups of caffeine-containing beverages. 22. Known history of intolerance or hypersensitivity to AX-202 or to any other component of the formulation.23. Known history of intolerance to placebo or excipients.24. Clinically significant serious adverse reaction, allergy or serious hypersensitivity, including to any drug or food, as judged by the Investigator.25. Involvement in the planning and conduct of the study.26. Participation in another clinical study with an experimental drug within 3 months (non-biologic), 6 months (biologic) or 5 half-lives, whichever is longer, before the administration of IMP.27. Considered unsuitable for entry into the study in any other way at the discretion of the Investigator, e.g. Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Dave
Singh
+44 (0)161 946 4073
dsingh@meu.org.uk
Dr
Jonas
Hallén
+47 92826003
jonas.hallen@arxxtx.com
Dr
Sylvia
Vetrhus
+47 922 01 571
sylvia.vetrhus@arxxtx.com
The study is sponsored by Arxx Therapeutics and funded by Arxx Therapeutics.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
