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Brivekimig

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Sanofi|Last Updated: Aug 20, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment208

FDA Designations

No designations recorded

Clinical trial landscape

Brivekimig · 2 trials · 2 indications

Phase 2 2
NCT07170917Brivekimig for the Treatment of Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa
RECRUITING208 Analytics
NCT06812988Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® MoleculeType 1 Diabetes Mellitus
ACTIVE NOT_RECRUITING84 Analytics
PHASE2RECRUITING
Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
Type 1 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Up to Week 16

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.

Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration
From Baseline to Week 26

Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)

Secondary Endpoints

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Up to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Up to Week 16
Change from Baseline in draining tunnel count at Week 16.
From Baseline to Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Brivekimig dose regimen AEXPERIMENTALParticipants will receive Brivekimig dose regimen A.
Brivekimig dose regimen BEXPERIMENTALParticipants will receive Brivekimig dose regimen B.
Brivekimig dose regimen CEXPERIMENTALParticipants will receive Brivekimig dose regimen C.
PlaceboPLACEBO_COMPARATORParticipants will receive Brivekimig matching placebo.
BrivekimigEXPERIMENTALParticipants will receive subcutaneous injection of brivekimig.

Interventions

NameTypeDescription
BrivekimigDRUG* 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: * 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), ...

Countries:United StatesAustraliaCanadaChileChinaCzechiaFranceGermanyGreeceHungaryIsraelItalyJapanNetherlandsPolandPuerto RicoSpainUnited Arab EmiratesUnited KingdomArgentinaBrazilSaudi Arabia
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Recent Changes (Last 90 Days)

MEDIUMAug 20, 2026NCT07170917primaryCompletionDate: changed
MEDIUMAug 20, 2026NCT07170917primaryCompletionDate: changed
LOWJun 12, 2026NCT07170917lastUpdatePostDate: changed
LOWJun 12, 2026NCT07170917lastUpdatePostDate: changed

Frequently asked questions about Brivekimig

What is Brivekimig used for?

Brivekimig is an investigational small molecule being developed for hidradenitis suppurativa and type 1 diabetes mellitus. It is in Phase 2 clinical development for both conditions. Brivekimig is not approved by the FDA and remains under investigation.

Who makes Brivekimig?

Brivekimig is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting Phase 2 clinical trials to evaluate the drug for hidradenitis suppurativa and type 1 diabetes mellitus.

What phase is Brivekimig in?

Brivekimig is in Phase 2 clinical development. It is being studied in two separate Phase 2 trials, one for hidradenitis suppurativa and one for type 1 diabetes mellitus. The drug is investigational and has not received FDA approval.

What clinical trials is Brivekimig in?

Brivekimig is being evaluated in two Phase 2 clinical trials. NCT06812988 is studying the drug in type 1 diabetes mellitus with an enrollment of 84 participants. NCT07170917 is studying the drug in moderate to severe hidradenitis suppurativa with an enrollment of 208 participants.

Is Brivekimig the same as a Nanobody molecule?

Brivekimig is being studied in a Phase 2 trial for type 1 diabetes mellitus that describes the treatment as an anti-OX40L bispecific with anti-TNF activity in a single Nanobody molecule. This trial is registered under NCT06812988.