PsoriasisBOMOGUMIPNCT04680624
Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patients
A study testing Fecal sample collection in people with Psoriasis, run by Association pour la Recherche Clinique et Immunologique.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Fecal sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patient - BOMOGUMIP
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
- Being tested
- Fecal sample collection
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal sample collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Other | Not described Receives: Procedure: Fecal sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of microbial composition of fecal samples after 6 months of Brodalumab treatment.
Microbial features impacted by anti-interleukin-17 treatment (Brodalumab).
Measured: At 6 months (Comparison V3/V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche Clinique et Immunologique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680624
- Sponsor's protocol ID
- 20071A0005
- Acronym
- BOMOGUMIP
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Brodalumab in the Modulation of Gut Microbiome in Psoriatic Patient - BOMOGUMIP
- ClinicalTrials.gov ID
- NCT04680624
- Acronym / sponsor ID
- BOMOGUMIP / 20071A0005
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Association pour la Recherche Clinique et ImmunologiqueUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Procedure: Fecal sample collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal sample collectionDuring 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. | Procedure or surgery | Single Group |
Primary outcome
Evolution of microbial composition of fecal samples after 6 months of Brodalumab treatment.
Time frame: At 6 months (Comparison V3/V1)
Microbial features impacted by anti-interleukin-17 treatment (Brodalumab).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal sample collection in people with Psoriasis, run by Association pour la Recherche Clinique et Immunologique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Gilibert (+33478861859, sophie.gilibert@lyonrechercheclinique.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of microbial composition of fecal samples after 6 months of Brodalumab treatment. (time frame: At 6 months (Comparison V3/V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.