Testing Brivekimig against a placebo for hidradenitis suppurativa
Official title: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study of Brivekimig Followed by a Maintenance Period in Participants With Moderate to Severe Hidradenitis Suppurativa
- Phase 2
- 4 groups
- Sites in Sherwood Park, Edmonton and 4 more cities
- Recruiting
Interventions
- Medication
Brivekimig
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
- Medication
Placebo
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Investigational Site Number : 1240008
Edmonton, Alberta
- Recruiting
Interior Dermatology Centre - Site Number: 1240003
Kelowna, British Columbia
- Recruiting
Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.
Hamilton, Ontario
- Recruiting
Investigational Site Number : 1240009
Toronto, Ontario
- Recruiting
Investigational Site Number: 1240005
Québec, Quebec
- Recruiting
Park Dermatology - Site number: 1240007
Sherwood Park
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to BaselineBaselineYour starting measurements, taken before treatment begins.Read more →
- +Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
- +Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → through participant interview and review of medical history.
- +Participants must be either biologic-naive or biologic-experienced.
- +Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit.
- +Participant must have a draining tunnel count of ≤20 at the Baseline visit.
Exclusion
- −A history of an Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- −Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, contraindicates participation in the study
- −Participants are excluded from the study if any of the following criteria apply:
- −Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
- −History of recurrent or recent serious infection
- −Known history of significant immunosuppression
- −History of solid organ transplant or stem cell transplant
- −History of splenectomy
- −History of moderate to severe congestive heart failure.
- −History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- −Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- −History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocolProtocolThe detailed plan a study must follow.Read more →
- −Active suicidality and therefore significant suicide risk, as judged by the Investigator
- −History (within last 2 years prior to Baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- −The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trialInterventional studyA study where participants are given something to see what happens.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A, B and C receive Brivekimig.
Registry label: A: Brivekimig dose regimen A · B: Brivekimig dose regimen B · C: Brivekimig dose regimen C
Group D, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: D: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 208 people.
The study is currently expected to finish around November 2029.
The main measurement is taken over: Up to Week 16.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) — measured over Up to Week 16.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07170917 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BrivekimigDrug
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
* Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to Week 16.
The study as a whole is currently expected to finish around 2029-11-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 208 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Sherwood Park, Canada; Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 164 weeks for participants transitioning into the long-term extension (LTE) period and will be up to approximately 60 weeks for participants not transitioning into the LTE period. The randomized treatment duration will be up to approximately 152 weeks
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.