Hidradenitis SuppurativaPhase 2BRIGHTENNCT07170917
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing Brivekimig in people with Hidradenitis Suppurativa, run by Sanofi at 85 sites in 19 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Brivekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 85 sitesin 19 countries
- Study dates
- 6 Nov 2025to 23 Nov 2029
- Phase
- Phase 2
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
- Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
- 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 Investigator 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.
Who cannot join
- 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
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- 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 protocol
- Active suicidality and therefore significant suicide risk, as judged by the Investigator
- A history of an Adverse Event (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 Investigator, contraindicates participation in the study
- History (within last 2 years prior to Baseline visit) 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 trial.
Trial locations and contacts
85 sites in 19 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
85 sites in 19 countries
United States17 sites, 17 recruiting
- Recruiting
Advanced Medical Research - Atlanta- Site Number : 8400011
Atlanta, Georgia, 30342
- Recruiting
Louisiana Dermatology Associates- Site Number : 8400006
Baton Rouge, Louisiana, 70809
- Recruiting
University of North Carolina at Chapel Hill- Site Number : 8400025
Chapel Hill, North Carolina, 27514
- Recruiting
Ut Southwestern Medical Center, Department Of Dermatology- Site Number : 8400022
Dallas, Texas, 75235
- Recruiting
Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8400001
Fort Myers, Florida, 33919
- Recruiting
Clinical Partners- Site Number : 8400002
Johnston, Rhode Island, 02919
- Recruiting
JDR Dermatology Research- Site Number : 8400012
Las Vegas, Nevada, 89145
- Recruiting
FXM Clinical Research - Miami- Site Number : 8400017
Miami, Florida, 33175
- Recruiting
FXM Clinical Research - Miramar- Site Number : 8400004
Miramar, Florida, 33027
- Recruiting
AMR Clinical South Strand, South Carolina- Site Number : 8400018
Myrtle Beach, South Carolina, 29588
- Recruiting
Icahn School of Medicine at Mount Sinai- Site Number : 8400021
New York, New York, 10029
- Recruiting
Northridge Clinical Trials - Northridge- Site Number : 8400005
Northridge, California, 91325
- Recruiting
Medical Dermatology Specialists- Site Number : 8400019
Phoenix, Arizona, 85006
- Recruiting
Georgia Skin & Cancer Clinic- Site Number : 8400009
Savannah, Georgia, 31419
- Recruiting
Mayo Clinic in Arizona - Scottsdale- Site Number : 8400014
Scottsdale, Arizona, 85259
- Recruiting
Washington University- Site Number : 8400010
St Louis, Missouri, 63110
- Recruiting
The Iowa Clinic West Des Moines Campus- Site Number : 8400007
West Des Moines, Iowa, 50266
Germany7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 2760002
Bochum, 44791
- Recruiting
Investigational Site Number : 2760008
Bramsche, 49565
- Recruiting
Investigational Site Number : 2760003
Frankfurt, 60590
- Recruiting
Investigational Site Number : 2760005
Kiel, 24105
- Recruiting
Investigational Site Number : 2760004
Mainz, 55131
- Recruiting
Investigational Site Number : 2760001
Münster, 48149
- Recruiting
Investigational Site Number : 2760006
Würzburg, 97080
Spain7 sites, 7 recruiting
- Recruiting
Investigational Site Number : 7240004
Cadiz, Andalusia, 11009
- Recruiting
Investigational Site Number : 7240007
Granada, 18014
- Recruiting
Investigational Site Number : 7240003
Las Palmas de Gran Canaria, Las Palmas, 35010
- Recruiting
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad de, 28046
- Recruiting
Investigational Site Number : 7240005
Madrid, 28007
- Recruiting
Investigational Site Number : 7240002
Manises, Valencia, 46940
- Recruiting
Investigational Site Number : 7240006
Santiago de Compostela, A Coruña [La Coruña], 15706
Canada6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 1240008
Edmonton, Alberta, T6H 4J8
- Recruiting
Investigational Site Number : 1240001
Hamilton, Ontario, L8L 3C3
- Recruiting
Investigational Site Number : 1240003
Kelowna, British Columbia, V1W 4V5
- Recruiting
Investigational Site Number : 1240005
Québec, Quebec, G1W 4R4
- Recruiting
Investigational Site Number : 1240007
Sherwood Park, Alberta, T8H 0P1
- Recruiting
Investigational Site Number : 1240009
Toronto, Ontario, M4E 1R7
France6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 2500001
Antony, 92160
- Recruiting
Investigational Site Number : 2500004
Bezannes, 51430
- Recruiting
Investigational Site Number : 2500003
Bordeaux, 33000
- Recruiting
Investigational Site Number : 2500002
Lyon, 69003
- Recruiting
Investigational Site Number : 2500006
Saint-Priest-en-Jarez, 42270
- Recruiting
Investigational Site Number : 2500007
Toulouse, 31059
Chile5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7580206
- Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7640881
- Recruiting
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8380465
- Recruiting
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 8420383
- Recruiting
Investigational Site Number : 1520004
Talcahuano, Biobio, 2687000
Italy5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 3800001
Catania, 95123
- Recruiting
Investigational Site Number : 3800002
Milan, Milano, 20122
- Recruiting
Investigational Site Number : 3800004
Rome, Lazio, 00144
- Recruiting
Investigational Site Number : 3800006
Rome, Roma, 00167
- Recruiting
Investigational Site Number : 3800005
Rozzano, Milano, 20089
China4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 1560002
Chengdu, 610041
- Recruiting
Investigational Site Number : 1560001
Guangzhou, 510018
- Recruiting
Investigational Site Number : 1560004
Shanghai, 200040
- Recruiting
Investigational Site Number : 1560005
Ürümqi, 830001
Czechia4 sites
- Active, not recruiting
Investigational Site Number : 2030002
Ostrava, 702 00
- Active, not recruiting
Investigational Site Number : 2030003
Ostrava, 708 52
- Active, not recruiting
Investigational Site Number : 2030001
Prague, 110 00
- Active, not recruiting
Investigational Site Number : 2030004
Prague, 150 06
Greece4 sites, 4 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 124 62
- Recruiting
Investigational Site Number : 3000001
Athens, 16121
- Recruiting
Investigational Site Number : 3000005
Athens, 16121
- Recruiting
Investigational Site Number : 3000004
Thessaloniki, 564 29
Poland4 sites
- Active, not recruiting
Investigational Site Number : 6160003
Lodz, Lódzkie, 90-265
- Active, not recruiting
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, 02-507
- Active, not recruiting
Investigational Site Number : 6160004
Wroclaw, Lower Silesian Voivodeship, 50-088
- Active, not recruiting
Investigational Site Number : 6160001
Wroclaw, Lower Silesian Voivodeship, 50-566
Hungary3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3480001
Debrecen, 4032
- Recruiting
Investigational Site Number : 3480003
Pécs, 7632
- Recruiting
Investigational Site Number : 3480004
Székesfehérvár, 8000
Israel3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3760003
Haifa, 3109601
- Recruiting
Investigational Site Number : 3760002
Jerusalem, 9112001
- Recruiting
Investigational Site Number : 3760001
Tel Aviv, 6423906
Japan3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3920002
Nishihara, Okinawa, 903-0215
- Recruiting
Investigational Site Number : 3920003
Nishinomiya, Hyōgo, 663-8186
- Recruiting
Investigational Site Number : 3920001
Tokyo, 173-8610
Australia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0360003
Liverpool, New South Wales, 2170
- Recruiting
Investigational Site Number : 0360002
Melbourne, Victoria, 3004
United Kingdom2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 8260006
Leeds, LS9 7TF
- Recruiting
Investigational Site Number : 8260008
London, England, E1 1BB
Netherlands1 site, 1 recruiting
- Recruiting
Investigational Site Number : 5280002
Groningen, 9713 GR
Puerto Rico1 site, 1 recruiting
- Recruiting
Grupo Dermatologico de Carolina- Site Number : 8400023
Carolina, 00985
United Arab Emirates1 site, 1 recruiting
- Recruiting
Investigational Site Number : 7840001
Abu Dhabi
About this study
Official title: 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
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
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Brivekimig, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivekimigDrug
Also called SAR442970
- Pharmaceutical form: Solution for injection in vial
- Route of administration: Subcutaneous injection
PlaceboDrug
- Pharmaceutical form: Solution for injection in vial
- Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Brivekimig dose regimen A | Experimental | Participants will receive Brivekimig dose regimen A. Receives: Drug: Brivekimig |
| Brivekimig dose regimen B | Experimental | Participants will receive Brivekimig dose regimen B. Receives: Drug: Brivekimig |
| Brivekimig dose regimen C | Experimental | Participants will receive Brivekimig dose regimen C. Receives: Drug: Brivekimig |
| Placebo | Placebo comparator | Participants will receive Brivekimig matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Measured: Up to Week 16
Secondary outcomes (10)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Measured: Up to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) is defined as ≥90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.
Measured: Up to Week 16
Change from Baseline in draining tunnel count at Week 16.
Measured: From Baseline to Week 16
Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Measured: From Baseline to Week 16
Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. The HS-SAQ Skin Pain is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). HS-SAQ skin pain NRS response is defined as ≥3-unit reduction from baseline in the weekly average of daily HS-SAQ Skin Pain NRS.
Measured: From Baseline to Week 8
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.
The Hidradenitis Suppurativa Quality of Life is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
Measured: From Baseline to Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Measured: From Baseline to Week 16
Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.
Measured: Up to End of Study (approximately 164 weeks)
Serum brivekimig concentration throughout the study.
Measured: From Baseline to Week 160
Incidence of treatment-emergent (TE) anti-drug antibody responses.
Measured: Up to End of Study (approximately 164 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start6 Nov 2025
- Primary completion9 Feb 2027 (estimated)
- Study completion23 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170917
- Sponsor's protocol ID
- DRI19220
- Other IDs
- 2025-522333-61-00, U1111-1318-3453, 2025
- Acronym
- BRIGHTEN
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org