Brivekimig for the treatment of moderate to severe hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

23 Jan 2026 → ongoing

Decision date (initial)

2026-01-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-522333-61-00

WHO UTN

U1111-1318-3453

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Dose response, Safety

Evaluate the efficacy of different dosing regimens of brivekimig for the treatment of study participants with moderate to severe Hidradenitis suppurativa.

Secondary objectives 5

1. Evaluate the effect of different dosing regimens of brivekimig on Hidradenitis suppurativa Clinical Parameters.
2. Evaluate the effect of different dosing regimens of brivekimig on pain
3. Evaluate the effect of different dosing regimens of brivekimig on quality of life.
4. Evaluate the safety of different dosing regimens of brivekimig.
5. Evaluate pharmacokinetics and the potential for immunogenicity of brivekimig in treated study participants

Conditions and MedDRA coding

Hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. - Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline.
2. - 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.
3. - 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
4. - Participants must be either biologic-naive or biologic-experienced
5. - Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit
6. - Participant must have a draining tunnel count of ≤20 at the Baseline visit.

Exclusion criteria 13

1. - Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
2. - History of recurrent or recent serious infection
3. - Known history of significant immunosuppression
4. - History of solid organ transplant or stem cell transplant.
5. - History of splenectomy.
6. - History of moderate to severe congestive heart failure.
7. - History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
8. - 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.
9. - History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
10. - Active suicidality and therefore significant suicide risk, as judged by the Investigator
11. - 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 re-administration of an anti-TNF class therapy.
12. - 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.
13. - History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Secondary endpoints 10

1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
2. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
3. Change from Baseline in draining tunnel count at Week 16.
4. Change from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
5. 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
6. Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.
7. Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.
8. Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.
9. Serum brivekimig concentration throughout the study
10. Incidence of treatment-emergent (TE) anti-drug antibody responses.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 11

Locations

9 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 135 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications