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Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patients | Clinical Trials | Clareo Health

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

Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patient - BOMOGUMIP

NCT04680624•Association pour la Recherche Clinique et Immunologique

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

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
+5 more criteria

Key Dates

Start Date

January 1, 2021

Primary Completion Date

January 1, 2022

Completion Date

January 1, 2022

Last Updated

December 23, 2020

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

Fecal sample collection

PROCEDURE

Contacts

Sophie Gilibert

CONTACT

+33478861859 sophie.gilibert@lyonrechercheclinique.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments