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 and Over|
- - Subject over 18 years of age.
- - Subject able to read, understand and give documented informed consent.
- - Subject willing and able to comply with the protocol requirements for the duration of the study.
- - Subject with health insurance coverage according to local regulations.
- - For woman with childbearing potential; - Use of a highly effective method of birth control from at least 1 month prior to study enrollment until the last visit.
- - Negative urine pregnancy test at inclusion visit A highly effective method of birth controlled is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, combined oral contraceptives, intrauterine device, barrier methods, sexual abstinence or vasectomized partner.
- - Subject diagnosed with plaque psoriasis.
- - Subject treated with methotrexate (≥ 15mg/weeks) for at least 4 months and having inadequate response or intolerance to methotrexate treatment.
- - Subject starting a Brodalumab treatment as a first line of biological treatment (switching from methotrexate to Brodalumab treatment) Note: treatment decision must has been taken by the investigator prior to, and independently of the patient inclusion into the study.
- - Pregnancy or breast-feeding women, or planning to change contraception method or become pregnant or breastfeed during the study.
- - Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of psoriasis.
- - Subject treated by immunosuppressant drug except methotrexate (e.g. phototherapy, ciclosporin, apremilast, steroids or other systemic immunosuppressive) within 3 months before inclusion.
- - Subject treated by Non-Steroidal Anti-Inflammatory Drugs (NSAID), antibiotics or proton-pump inhibitors within 4 weeks before inclusion or foreseeable use during the study.
- - Subject previously treated by a biologic therapy.
- - Subject with a concomitant diagnosis of cirrhosis, coeliac disease or sign of bacterial infection.
- - Subject having a personal or familial history of psoriatic arthritis or inflammatory bowel disease.
- - Subject with a Body Mass Index (BMI)<18.5 or BMI>35.
- - Subject consuming probiotics or using specific diet (e.g. gluten-free, vegetarian, vegan, intermittent fasting) or planning to adopt a specific diet during the study.
- - Subject having a planned surgery during the study.
- - Subject presenting clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact patient's ability to participate in the study or to impact the study efficacy or safety assessments.
- - Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk.
- - Linguistic or mentally incapacity to sign the consent form.
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.
|Association pour la Recherche Clinique et Immunologique|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Other: Single Group
Procedure: - Fecal sample collection
During the study, patients will be ask to collect fecal samples using sample collection kits. A total of 4 stool samples per patient will be collected.