Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07170917

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Led by Sanofi · Updated on 2026-04-08

208

Participants Needed

69

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

CONDITIONS

Official Title

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months before baseline
  • HS lesions present in at least 2 different areas, with at least one area being Hurley Stage II or III
  • Inadequate response, recurrence, intolerance, or contraindication to oral antibiotics for HS
  • Biologic-naive or biologic-experienced participants
  • Total abscess and inflammatory nodule count of 5 or more at baseline
  • Draining tunnel count of 20 or fewer at baseline
Not Eligible

You will not qualify if you...

  • Presence of other active skin diseases or infections that interfere with HS assessment
  • History of recurrent or recent serious infections
  • Known significant immunosuppression
  • History of solid organ or stem cell transplant
  • History of splenectomy
  • Moderate to severe congestive heart failure
  • History of demyelinating disease or related neurological symptoms
  • History of malignancy or lymphoproliferative disease except certain treated skin cancers
  • Any condition that poses risk for participation per investigator's judgment
  • Active suicidality or significant suicide risk
  • Prior serious adverse events related to anti-TNF therapy contraindicating re-administration
  • Sensitivity or allergy to study interventions or components
  • History of significant prescription drug or substance abuse including alcohol within 2 years prior to baseline

AI-Screening

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Trial Site Locations

Total: 69 locations

1

Northridge Clinical Trials - Northridge- Site Number : 8400005

Northridge, California, United States, 91325

Actively Recruiting

2

FXM Clinical Research - Miami- Site Number : 8400017

Miami, Florida, United States, 33175

Actively Recruiting

3

FXM Clinical Research Miramar, LLC - Site Number: 8400004

Miramar, Florida, United States, 33027

Actively Recruiting

4

Advanced Medical Research - Atlanta- Site Number : 8400011

Atlanta, Georgia, United States, 30342

Actively Recruiting

5

Georgia Skin & Cancer Clinic- Site Number : 8400009

Savannah, Georgia, United States, 31419

Actively Recruiting

6

The Iowa Clinic West Des Moines Campus- Site Number : 8400007

West Des Moines, Iowa, United States, 50266

Actively Recruiting

7

Louisiana Dermatology Associates- Site Number : 8400006

Baton Rouge, Louisiana, United States, 70809

Actively Recruiting

8

JDR Dermatology Research - Site number: 8400012

Las Vegas, Nevada, United States, 89145

Actively Recruiting

9

Clinical Partners- Site Number : 8400002

Johnston, Rhode Island, United States, 02919

Actively Recruiting

10

AMR Clinical South Strand, South Carolina- Site Number : 8400018

Myrtle Beach, South Carolina, United States, 29588

Actively Recruiting

11

Alpine Research Association- Site Number : 8400008

Layton, Utah, United States, 84041

Actively Recruiting

12

Investigational Site Number: 0360001

Liverpool, New South Wales, Australia, 2170

Actively Recruiting

13

Alfred Hospital - Site Number: 0360002

Melbourne, Victoria, Australia, 3004

Actively Recruiting

14

Interior Dermatology Centre - Site Number: 1240003

Kelowna, British Columbia, Canada, V1W 4V5

Actively Recruiting

15

Lima's Excellence in Allergy and Dermatology Research (LEADER) Inc.

Hamilton, Ontario, Canada, L8L 3C3

Actively Recruiting

16

Investigational Site Number : 1240009

Toronto, Ontario, Canada, M4E 1R7

Actively Recruiting

17

Investigational Site Number: 1240005

Québec, Quebec, Canada, G1W 4R4

Actively Recruiting

18

Park Dermatology - Site number: 1240007

Sherwood Park, Canada, T8H 0P1

Actively Recruiting

19

Investigational Site Number: 1520003

Santiago, Reg Metropolitana de Santiago, Chile, 7580206

Actively Recruiting

20

Investigational Site Number: 1520002

Santiago, Reg Metropolitana de Santiago, Chile, 7640881

Actively Recruiting

21

Investigational Site Number: 1520001

Santiago, Reg Metropolitana de Santiago, Chile, 8380465

Actively Recruiting

22

Investigational Site Number: 1520005

Santiago, Reg Metropolitana de Santiago, Chile, 8420383

Actively Recruiting

23

Investigational Site Number : 1560002

Chengdu, China, 610041

Actively Recruiting

24

Investigational Site Number : 1560001

Guangzhou, China, 510018

Actively Recruiting

25

Investigational Site Number : 1560005

Ürümqi, China, 830001

Actively Recruiting

26

Investigational Site Number: 2030002

Ostrava, Czechia, 702 00

Actively Recruiting

27

Investigational Site Number: 2030003

Ostrava, Czechia, 708 52

Actively Recruiting

28

Investigational Site Number: 2030001

Prague, Czechia, 110 00

Actively Recruiting

29

Investigational Site Number: 2030004

Prague, Czechia, 150 06

Actively Recruiting

30

Investigational Site Number: 2500001

Antony, France, 92160

Actively Recruiting

31

Investigational Site Number: 2500004

Bezannes, France, 51430

Actively Recruiting

32

Investigational Site Number : 2500003

Bordeaux, France, 33000

Actively Recruiting

33

Investigational Site Number : 2500002

Lyon, France, 69003

Actively Recruiting

34

Investigational Site Number : 2500006

Saint-Priest-en-Jarez, France, 42270

Actively Recruiting

35

Investigational Site Number: 2500007

Toulouse, France, 31059

Actively Recruiting

36

Investigational Site Number : 2760002

Bochum, Germany, 44791

Actively Recruiting

37

Investigational Site Number : 2760008

Bramsche, Germany, 49565

Actively Recruiting

38

Investigational Site Number : 2760003

Frankfurt, Germany, 60590

Actively Recruiting

39

Investigational Site Number : 2760005

Kiel, Germany, 24105

Actively Recruiting

40

Investigational Site Number : 2760004

Mainz, Germany, 55131

Actively Recruiting

41

Investigational Site Number : 2760001

Münster, Germany, 48149

Actively Recruiting

42

Investigational Site Number : 2760006

Würzburg, Germany, 97080

Actively Recruiting

43

Investigational Site Number : 3000001

Athens, Greece, 161 21

Actively Recruiting

44

Investigational Site Number : 3000005

Athens, Greece, 161 21

Actively Recruiting

45

Investigational Site Number : 3000004

Thessaloniki, Greece, 564 29

Actively Recruiting

46

Site Number: 3480001

Debrecen, Gangwon-do, Hungary, 4032

Actively Recruiting

47

Investigational Site Number: 3480003

Pécs, Hungary, 7632

Actively Recruiting

48

Investigational Site Number : 3480004

Székesfehérvár, Hungary, 8000

Actively Recruiting

49

Investigational Site Number: 3760002

Jerusalem, Israel, 9112001

Actively Recruiting

50

Investigational Site Number: 3760001

Tel Aviv, Israel, 6423906

Actively Recruiting

51

Investigational Site Number: 3800002

Milan, Milano, Italy, 20122

Actively Recruiting

52

Istituto Dermatologico San Gallicano, IRCCS - Site Number : 3800004

Roma, Italy, 00144

Actively Recruiting

53

Meiwa Hospital

Nishinomiya, Hyōgo, Japan, 663-8186

Actively Recruiting

54

University of the Ryukyus Hospital - Site Number: 3920002

Nishihara, Okinawa, Japan, 903-0215

Actively Recruiting

55

Nihon University Itabashi Hospital

Tokyo, Japan, 173-8610

Actively Recruiting

56

Investigational Site Number : 5280002

Groningen, Netherlands, 9713 GR

Actively Recruiting

57

Investigational Site Number: 6160001

Wroclaw, Lower Silesian Voivodeship, Poland, 50-566

Actively Recruiting

58

Investigational Site Number: 6160003

Lodz, Lódzkie, Poland, 90-265

Actively Recruiting

59

Investigational Site Number: 6160002

Warsaw, Masovian Voivodeship, Poland, 02-507

Actively Recruiting

60

Grupo Dermatologico de Carolina- Site Number : 8400023

Carolina, Puerto Rico, 00985

Actively Recruiting

61

Investigational Site Number: 7240006

Santiago de Compostela, A Coruña [La Coruña], Spain, 15706

Actively Recruiting

62

Investigational Site Number: 7240003

Las Palmas de Gran Canaria, Las Palmas, Spain, 35010

Actively Recruiting

63

Investigational Site Number: 7240002

Manises, Valencia, Spain, 46940

Actively Recruiting

64

Investigational Site Number: 7240004

Cadiz, Spain, 11009

Actively Recruiting

65

Investigational Site Number : 7240007

Granada, Spain, 18014

Actively Recruiting

66

Investigational Site Number: 7240005

Madrid, Spain, 28007

Actively Recruiting

67

Investigational Site Number: 7240001

Madrid, Spain, 28046

Actively Recruiting

68

Investigational Site Number : 8260008

London, England, United Kingdom, E1 1BB

Actively Recruiting

69

Investigational Site Number : 8260006

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa | DecenTrialz