Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patients

NCT04680624 | Unknown

• 1 other identifier: 20071A0005
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Evolution of microbial composition of fecal samples after 6 months of Brodalumab treatment.

  Microbial features impacted by anti-interleukin-17 treatment (Brodalumab).

  At 6 months (Comparison V3/V1)

Study Arms (1)

Single Group

OTHER

Procedure: Fecal sample collection

Interventions

Fecal sample collection PROCEDURE

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.

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Association pour la Recherche Clinique et Immunologique: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sophie Gilibert

CONTACT

+33478861859; sophie.gilibert@lyonrechercheclinique.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 23, 2020

Record last verified: 2020-12