NCT04979520

Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Completed EARLY_PHASE1 Last updated 27 July 2022

What this trial tests

EARLY_PHASE1 trial testing Brodalumab in Hidradenitis Suppurativa in 4 participants. Completed in 25 July 2022.

Timeline

5 August 2021

Primary endpoint
25 July 2022

25 July 2022

Quick facts

Lead sponsor	Rockefeller University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	4
Start date	5 August 2021
Primary completion	25 July 2022
Estimated completion	25 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Brodalumab (BRODALUMAB) — full drug profile →

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →
• Acne Inversa — all drugs for Acne Inversa →

Sponsor

Rockefeller University

Who can join

Adults 18 to 99, any sex, with Hidradenitis Suppurativa or Acne Inversa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interactions between neutrophils and T-helper 17 cells.
   Fan X, Shu P, Wang Y, Ji N, et al · · 2023 · cited 51× · PMID 37920459 · DOI 10.3389/fimmu.2023.1279837
2. New and Emerging Targeted Therapies for Hidradenitis Suppurativa.
   Markota Čagalj A, Marinović B, Bukvić Mokos Z. · · 2022 · cited 46× · PMID 35409118 · DOI 10.3390/ijms23073753
3. Insights into the Pathogenesis of HS and Therapeutical Approaches.
   Rosi E, Fastame MT, Scandagli I, Di Cesare A, et al · · 2021 · cited 27× · PMID 34572354 · DOI 10.3390/biomedicines9091168
4. IL-17 Inhibition: A Valid Therapeutic Strategy in the Management of Hidradenitis Suppurativa.
   Malvaso D, Calabrese L, Chiricozzi A, Antonelli F, et al · · 2023 · cited 19× · PMID 37896210 · DOI 10.3390/pharmaceutics15102450
5. New Insight into the Molecular Pathomechanism and Immunomodulatory Treatments of Hidradenitis Suppurativa.
   Molinelli E, Gioacchini H, Sapigni C, Diotallevi F, et al · · 2023 · cited 17× · PMID 37176138 · DOI 10.3390/ijms24098428
6. The Current Clinical Trial Landscape for Hidradenitis Suppurativa: A Narrative Review.
   Hunt A, Qian V, Olds H, Daveluy S. · · 2023 · cited 10× · PMID 37261652 · DOI 10.1007/s13555-023-00935-x
7. Emerging Treatments and the Clinical Trial Landscape for Hidradenitis Suppurativa Part I: Topical and Systemic Medical Therapies.
   Fragoso NM, Masson R, Gillenwater TJ, Shi VY, et al · · 2023 · cited 9× · PMID 37402031 · DOI 10.1007/s13555-023-00956-6
8. Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa.
   Pinto Salgueiro G, Yilmaz O, Nogueira M, Torres T. · · 2025 · cited 8× · PMID 39604776 · DOI 10.1007/s40259-024-00687-w