Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patients (BOMOGUMIP)

Association pour la Recherche Clinique et Immunologique

Status

Unknown

Conditions

Psoriasis

Treatments

Procedure: Fecal sample collection

Study type

Interventional

Funder types

Other

Identifiers

NCT04680624

20071A0005

Details and patient eligibility

About

BOMOGUMIP is an interventional research with minimal risk and constraints (cat.2), exploratory, intra-individual, prospective, multi-site study. The main objective of this intra individual prospective study is to determine the evolution of microbial composition of fecal samples issued to 15 patients after 6 months of Brodalumab treatment.

The population will consist of 15 adult patients suffering from moderate to severe skin psoriasis and starting, after having received a methotrexate treatment during at least 4 months, a brodalumab treatment in the first line of biological treatment.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Woman with no childbearing potential is defined as: woman with amenorrhea for at least 12 months (without an alternative medical cause); woman who had undergone a permanent sterilization method (eg bilateral tubal occlusion which includes tubal ligation procedures, hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy.

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. Thus, all recommendation and contraindication to the use of Brodalumab will be applicable (see section 6. Treatment).

Exclusion criteria

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
Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated)
Subject in an exclusion period from a previous study or who is participating in another clinical trial